sTANDARD TREATMENT Guidelines

3
The Diabetic Foot
Prevention and Management in India

August 2017
HEALTH M
AL
Ministry of Health & Family Welfare
NATION

ISSI N
O

Government of India
 HEALTH M
AL

NATION

ISSI N
O
sTANDARD TREATMENT Guidelines
The Diabetic Foot
Prevention and Management in India

August 2017

Ministry of Health & Family Welfare

Government of India
©2017

Ministry of Health and Family Welfare

Government of India, Nirman Bhawan
New Delhi-110 011

Reproduction of any excerpts from this documents does not require permission from
the publisher so long it is verbatim, is meant for free distribution and the source is
acknowledged.

ISBN: 978-93-82655-21-3

Design by: Macro Graphics Pvt. Ltd. (www.macrographics.com)

 Table of Contents

Introduction 1

Case Definition 3

Incidence of Diabetic foot in India 5

Recommendations 7

Prevention 9

Assessment, Classification and Referral 10

Diabetic Foot Infections 16

Wound Care 19

Footwear 21

Treatment of Diabetic foot with Osteomyelitis 23

Charcot’s Foot 24

Surgical Interventions and Revascularization 26

Guideline Development Process  29

Background 29

Overview 29

Table of Contents iii

 Introduction

I ndia is set to become the diabetes capital of the world with a projected 109 million
individuals with diabetes by 2035. India ranks second (after China) with more than 66.8
million diabetics in the age group of 20-70. The prevalence of Diabetes in India is 8.6% and,
as of 2013, more than 1 million Indians die each year due to diabetes related causes.

Diabetic foot care is one of the most ignored aspects of diabetes care in India. Due to
social, religious, and economic compulsions, many people walk barefoot. Poverty and
lack of education lead to usage of inappropriate footwear and late presentation of foot
lesions. Many non-medically qualified persons are interfering in the treatment of diseases,
including diabetes. Patients also try home remedies before visiting their physicians. It
estimated that 90% of diabetic patients in India do not see a specialist in their lifetime.
Problem is further worsened by a delay in accessing healthcare due to patient approaching
informal care providers and alternative medicine prescribers.

There is a lack of a good evidence-based standard guideline on Diabetic foot care

in India. Currently, diabetic feet are treated by individual practitioners. Physicians,
General surgeons, or thopaedic surgeons, primary care physicians, endocrinologists and
podiatrists all look after the diabetic feet. But neither their roles, responsibilities nor the
protocols are clearly defined in the public domain. Moreover, in the Indian context, due
to the pronounced variability in the health care system, a common national guidance
for providing curative as well as preventive methods to curb the growth of diabetic foot
in the future is essential. Hence, it is a public health imperative to create an integrated
framework for comprehensive management of diabetic foot.

Introduction 1
 Case Definition

D iabetic foot as defined by the World Health Organization is, “The foot of a diabetic
patient that has the potential risk of pathologic consequences, including infection,
ulceration, and/or destruction of deep tissues associated with neurologic abnormalities,
various degrees of peripheral vascular disease, and/or metabolic complications of diabetes
in the lower limb”.

Case Definition 3
 Incidence of
Diabetic foot in India

D iabetic Foot (DF) is one of the most common complications for admissions imposing
tremendous medical and financial burden on our healthcare system. The lifetime risk
of a person with diabetes having a foot ulcer could be as high as 25% and is the commonest
reason for hospitalization of diabetic patients (about 30%) and absorbs about 20% of the
total health-care costs, more than all other diabetic complications. The prevalence of foot
ulcers in diabetics attending a centre managing diabetic foot (both indoor and outdoor
setup) in India is 3%. Foot ulcers among outpatient and inpatient diabetics attending
hospitals in rural India was found to be 10.4%.

Peripheral vascular disease (PVD) occurs in about 3.2% diabetics below 50 years of age
and rises to 55% in those above 80 years of age. 15% of those with diabetes for a decade
suffer from diabetic foot, where as it increases to almost 50% by another decade.

Approximately, 85% of non-traumatic lower limb amputations are seen in patients with
prior history of diabetic foot ulcer. Each year, more than 1 million people with diabetes lose
at least a part of their leg due to diabetic foot. It shows that every 20 seconds a limb is lost
in the world somewhere. In India, though recent population based data is not available, it
is estimated that approximately 45,000 legs are amputated every year in India. The vast
majority (75%) of these are probably preventable because the amputation often results
from an infected neuropathic foot. More than half of all foot ulcers become infected,
requiring hospitalization, while 20% of infections result in amputation. After a major
amputation, 50% of people will have the other limb amputated within two years’ time.
People with a history of diabetic foot ulcer have a 40% greater 10-year death rate than
people with diabetes alone.

Incidence of Diabetic foot in India 5

 Recommendations

Clinical pathway 1:
Overview of Foot care in Diabetes

FOOT CARE
in Diabetes
(Pathway no. 1)

REDUCE the risk of

Diabetic Foot problem
(Go to pathway no. 2)

MANAGE the
Diabetic Foot problem
(Go to pathway no. 3)

Recommendations 7
 Clinical pathway 2 : Prevention of Diabetic Foot

REDUCE the risk of Diabetic Foot problem

(Pathway no. 2)

Educate the patient regarding DF care

(Go to the Patient Information Document)

Assessing the Risk

(Go to the Recommendation no. 4.2.1)

Frequency of follow up
(Go to the Recommendation no. 4.1.1)

Managing the Risk

(Go to the Recommendation nos. 4.1.2 to
4.1.10 and also 4.5.1 to 4.5.8)

MANAGE the Diabetic Foot problem

(Go to pathway no. 3)

8 The Diabetic foot | Prevention and management in India

4.1 PREVENTION
Overview
yy Identification of the at-risk foot
yy Regular inspection and examination of the at-risk foot
yy Education of patient, family and healthcare providers
yy Routine wearing of appropriate footwear
yy Treatment of pre-ulcerative signs

Prevention of Diabetic foot problems

4.1.1 To identify a person with diabetes at risk for foot ulceration, examine the feet annually /
six monthly / quarterly / monthly (depending on patient’s risk category) to seek evidence
for signs or symptoms of peripheral neuropathy and peripheral artery disease.

Risk Classification System and preventive screening frequency

Category Characteristic Frequency

0 No peripheral neuropathy Once a year

1 Peripheral neuropathy Once every six months

2 Peripheral neuropathy with peripheral artery disease Once every 3-6 months
and/or a foot deformity

3 Peripheral neuropathy and a history of foot ulcer Once every 1-3 months
or lower-extremity amputation
Source : The IWGDF guidelines 2015.

4.1.2 In a person with diabetes who has peripheral neuropathy, screen for: a history of
foot ulceration or lower-extremity amputation; peripheral artery disease; foot
deformity; pre-ulcerative signs on the foot; poor foot hygiene; and ill-fitting or
inadequate footwear.

4.1.3 Treat any pre-ulcerative sign on the foot of a patient with diabetes. This includes:
removing callus; protecting blisters and draining when necessary; treating ingrown
or thickened toe nails; treating haemorrhage when necessary; and prescribing
antifungal treatment for fungal infections.

Recommendations 9
4.1.4 To protect their feet, instruct an at-risk patient with diabetes not to walk barefoot,
in socks, or in thin-soled standard slippers, whether at home or when outside.

4.1.5 Instruct an at-risk patient with diabetes to: daily inspect their feet and the inside of
their shoes; daily wash their feet (with careful drying particularly between the toes);
avoid using chemical agents or plasters to remove callus or corns; use emollients to
lubricate dry skin; and cut toe nails straight across.

4.1.6 Instruct an at-risk patient with diabetes to wear properly fitting footwear to prevent
a first foot ulcer, either plantar or non-plantar, or a recurrent non-plantar foot ulcer.
When a foot deformity or a pre-ulcerative sign is present, consider prescribing
therapeutic shoes, custom-made insoles, or toe orthosis.

4.1.7 Instruct a high-risk patient with diabetes to monitor foot skin temperature at home
to prevent a first or recurrent plantar foot ulcer. This aims at identifying the early
signs of inflammation, followed by action taken by the patient and care provider to
resolve the cause of inflammation.

4.1.8 To prevent a first foot ulcer in an at-risk patient with diabetes, provide education
aimed at improving foot care knowledge and behaviour, as well as encouraging the
patient to adhere to this foot care advice.

4.1.9 To prevent a recurrent plantar foot ulcer in an at-risk patient with diabetes,
prescribe therapeutic footwear that has a demonstrated plantar pressure relieving
effect during walking and encourage the patient to wear this footwear.

4.1.10 To prevent a recurrent foot ulcer in an at-risk patient with diabetes, provide
integrated foot care, which includes professional foot treatment, adequate footwear
and education. This should be repeated or re-evaluated once every one to three
months as necessary.

4.2 Assessment, Classification and Referral

4.2.1 Assessing the risk of developing a diabetic foot problem:

4.2.1a. Evaluate a diabetic patient presenting with a foot wound at 3 levels: the
patient as a whole, the affected foot or limb, and the infected wound.

4.2.1 b. Assess the affected limb and foot for arterial ischemia, venous
insufficiency, presence of protective sensation, and biomechanical
problems.

10 The Diabetic foot | Prevention and management in India

 Explanatory note: Biomechanical problems means anatomical and physiological
disturbances of the foot, i.e., structural changes which happen in the bones, joints
and muscles of the foot of diabetics and the changes in the blood circulation and
nerve sensation of the foot of diabetics.

Table 1: Infectious Diseases Society of America and International Working Group on the
Diabetic Foot Classifications of Diabetic Foot Infection

Clinical Manifestation of Infection PEDIS Grade IDSA

Infection
Uninfected: No symptoms or signs of infection 1 Uninfected
Infected: 2 Mild
At least two of the following items are present:
•• Local swelling or induration
•• Erythema >0.5cm around the wound
•• Local tenderness or pain
•• Local warmth
•• Purulent discharge (thick, opaque to white or sanguineous
secretion)
Exclude other causes of an inflammatory response of the skin (eg,
trauma, gout, acute Charcot neuro-osteoarthropathy, fracture,
thrombosis, venous stasis).
Local infection involving only the skin and the subcutaneous tissue
(without involvement of deeper tissues and without systemic signs
as described below).
An erythema, must be </=2 cm around the ulcer.
Local infection (as described above) with erythema > 2 cm, or 3 Moderate
involving structures deeper than skin and subcutaneous tissues
(eg, abscess, osteomyelitis, septic arthritis, fasciitis), and
No systemic inflammatory response signs (as described below)
Local infection (as described above) with the signs of SIRS, as 3 Severea
manifested by ≥2 of the following:
•• Temperature >38°C or <36°C
•• Heart rate >90 beats/min
•• Respiratory rate >20 breaths/min or PaCO2 <32 mm Hg
•• White blood cell count >12,000 or <4000 cells/μL or ≥10%
immature (band) forms

Recommendations 11
4.2.2 Classification of Diabetic foot:
4.2.2a. Assess the severity of any diabetic foot infection using the Infectious
Diseases Society of America/ International Working Group on the
Diabetic Foot Classification system.
Abbreviations: IDSA, Infectious Diseases Society of America; PaCO2,
partial pressure of arterial carbon dioxide; PEDIS, perfusion, extent/size,
depth/tissue loss, infection, and sensation; SIRS, systemic inflammatory
response syndrome.
4.2.2 b. Do not use the Wagner classification system to assess the severity of a
diabetic foot ulcer.
4.2.3 Referral for Diabetic foot problems
4.2.2a. Initially hospitalize all patients with a severe infection, selected patients
with a moderate infection with complicating features (eg, severe
peripheral arterial disease [PAD] or lack of home support), and any patient
unable to comply with the required outpatient treatment regimen for
psychological or social reasons. Also hospitalize patients who do not meet
any of these criteria, but are failing to improve with outpatient therapy.
(Also refer to Table 3 and 4 for explanatory notes.)

Table 3: Characteristics suggesting a more serious diabetic foot infection

A - Findings suggesting a more serious diabetic foot infection
Wound specific
Wound Penetrates to subcutaneous tissues, (e.g., fascia, tendon, muscle, joint, bone)
Cellulitis Extensive (>2 cm), distance from ulceration or rapidly progressive
Local signs Severe inflammation or induration, crepitus, bullae, discoloration, necrosis or
gangrene, ecchymoses or petechiae, new anaesthesia
General
Presentation Acute onset/worsening or rapidly progressive
Systemic signs Fever, chills, hypotension, confusion, volume depletion
Laboratory tests Leukocytosis, very high C-reactive protein or erythrocyte sedimentation
rate, severe/worsening hyperglycemia, acidosis, new/worsening azotaemia,
electrolyte abnormalities
Complicating Presence of a foreign body (accidental or surgically implanted), puncture
features wound, deep abscess, arterial or venous insufficiency, lymphedema,
immunosuppressive illness or treatment
Current treatment Progression while on apparently appropriate antibiotic and supportive therapy
Source : From the IWGDF guidelines 2015

12 The Diabetic foot | Prevention and management in India

Table 4: Factors indicating that hospitalization may be necessary

B - Factors suggesting hospitalization may be necessary

•• Severe infection (See Table 4A)

•• Metabolic or hemodynamic instability
•• Intravenous therapy needed (and not available/appropriate as outpatient)
•• Diagnostic tests needed that are not available as outpatient
•• Critical foot ischemia present
•• Surgical procedures (more than minor) required
•• Failure of outpatient management
•• Patient unable or unwilling to comply with outpatient-based treatment
•• Need for more complex dressing changes than patient/caregivers can provide
•• Need for careful, continuous observation

Note: A
 deep space infection may have deceptively few superficial signs, but clinicians should
consider this possibility in a patient with evidence of systemic toxicity, inflammation distant
from the skin wound, persistent infection or elevated inflammatory markers despite apparently
appropriate therapy, deterioration of previously controlled glycaemia or pain in a previously
insensate foot (21, 47, 125). The presence of foot ischemia is of particular concern, as it can
both diminish clinical findings and worsen prognosis. if in doubt, consider seeking consultation
from an experienced surgeon and evaluating with ultrasound, MRI or potentially other imaging
techniques.
Source : From the IWGDF guidelines 2015.

4.2.2 b. Prior to being discharged, make sure that a patient with a DFI (Diabetic
Foot Infection) is clinically stable; has had any urgently needed surgery
performed; has achieved acceptable glycemic control; is able to manage
(on his/her own or with help) at the designated discharge location; and
has a well defined plan that includes an appropriate antibiotic regimen
to which he/she will adhere, an off-loading scheme (if needed), specific
wound care instructions, and appropriate outpatient follow-up.

Recommendations 13
 clinical pathway 2.1: assessment of patients
Clinical Assessment at three levels

Patient as a whole Affected limb Wound/Ulcer

Duration of DM Glycaemic No wound Charcot’s Foot

Control (HbA1c) Anti-DM
medications Other
co-morbidities (HTN, IHD, CKD, Refer to higher
etc) Control of HTN centre
Management of IHD (Aspirin/
Clopidogrel/ Statin) Smoking
cessation Past history of
Ulceration/Infection/ No Cellulitis Cellulitis present
Amputation/Charcot’s foot
Look for
Oral Antibiotics
Scaling in OPD Mild Bed Rest
Corns/Calluses Follow up
Footwear modification

Web space Moderate Refer to

Topical Antifungal
fungal infection higher
Severe centre
Adequate trimming In-growing toe-nails

Protective Footwear
Gross Deformities
Corrective Surgery

Suspect PAD Skin changes

Absent sweating
Absent pedal
Refer to pulses ABI < 0.9
higher centre

10-gm
Suspect Monofilament
Neuropathy test Ipswich
touch test

14 The Diabetic foot | Prevention and management in India

 clinical pathway 3:
Overview of Management of Diabetic Foot

MANAGEMENT
of the Diabetic
Foot problem
(Pathway no. 3)

When to Refer ?
(Go to the Recommendation
nos. 4.2.3 and 4.7.2)

Inform the patient his/her clinical

condition and what all investigations and treatment
are needed

DF infection/ Ulcer /
Vasculopathy Charcot’s Foot
Osteomyelitis
(4.8.14) (4.7.1)
(4.2.2, 4.3.1, 4.3.2)

Investigations Investigations Inves�ga�ons

(4.3.3, 4.3.4, (4.8.9 to 4.8.13, 4.8.15, (4.7.3 to 4.7.5)
4.6.1 to 4.6.4) 4.8.16)

Treatment Treatment Treatment

(4.3.5, (4.8.12, 4.8.13, 4.8.17 to (4.7.6 to 4.7.10)
4.4.1 to 4.4.11, 4.8.24)
4.5.1 to 4.5.8,
4.6.5 to 4.6.7,
4.8.1 to 4.8.8
4.8.12 to 4.8.13,
4.8.21 to 4.8.24)

Recommendations 15
4.3 DIABETIC FOOT INFECTIONS
4.3.1 Consider the possibility of infection occurring in any foot wound in a patient with
diabetes. Evidence of infection generally includes classic signs of inflammation
(redness, warmth, swelling, tenderness, or pain) or purulent secretions, but may
also include additional or secondary signs (e.g., non-purulent secretions, friable or
discolored granulation tissue, undermining of wound edges, foul odor).

4.3.2 Be aware of factors that increase the risk for diabetic foot infections (DFI) and
especially consider infection when these factors are present; these include a wound
for which the probe-to-bone (PTB) test is positive; an ulceration present for >30
days; a history of recurrent foot ulcers; a traumatic foot wound; the presence
of peripheral vascular disease in the affected limb; a previous lower extremity
amputation; loss of protective sensation; the presence of renal insufficiency; or a
history of walking barefoot.

4.3.3 Take plain radiographs of the affected foot of all patients presenting with a new
Diabetic Foot Infection to look for bony abnormalities (deformity, destruction) as
well as for soft tissue gas and radio-opaque foreign bodies.

4.3.4 When and how to obtain culture from Diabetic foot patients?

4.3.4a. For clinically uninfected wounds, do not collect a specimen for culture.
4.3.4 b. Send a specimen for culture that is from deep tissue, obtained by biopsy
or curettage and after the wound has been cleansed and debrided. Avoid
swab specimens, especially of inadequately debrided wounds, as they
provide less accurate results.
Explanatory note: Wash the wound with saline and the surrounding skin
with antiseptic solution before taking culture to avoid contamination of
the specimen obtained for culture.
4.3.4c. Do not obtain repeat cultures unless the patient is not clinically
responding to treatment.
Explanatory note - Expert consensus says that if the signs of inflammation
do not subside even after 72 hours of starting treatment, then it should be
considered that patient is not responding.
4.3.4d. For infected wounds, clinicians should send appropriately obtained
specimens for culture prior to starting empiric antibiotic therapy, if

16 The Diabetic foot | Prevention and management in India

 possible. Cultures may be unnecessary for a mild infection in a patient
who has not recently received antibiotic therapy.

4.3.5 Selection of Antibiotic and when should it be modified?

4.3.5a. Do not treat clinically uninfected wounds with antibiotic therapy.
4.3.5b. Prescribe antibiotic therapy for all infected wounds but caution that this is
often insufficient unless combined with appropriate wound care.
4.3.5 c. Base the route of therapy largely on infection severity. Prefer parenteral
therapy for all severe, and some moderate DFls, at least initially with a
switch to oral agents when the patient is systemically well and culture
results are available. Clinicians can probably use highly bioavailable
oral antibiotics alone in most mild, and in many moderate infections and
topical therapy for selected mild superficial infections.
4.3.5d. Select an empiric antibiotic regimen on the basis of the severity of the
infection and the likely etiologic agent (s):

a. For mild to moderate infections in patients who have not recently

received antibiotic treatment, therapy just targeting aerobic gram-
positive cocci (GPC) is sufficient

b. For most severe infections, start broad-spectrum empiric antibiotic

therapy, pending culture results and antibiotic susceptibility data.

c. Empiric therapy directed at P. aeruginosa is usually unnecessary

except for patients with risk factors* for true infection with this
organism.

d. Consider providing empiric therapy directed against MRSA in a

patient with a prior history of MRSA infection; when the local
prevalence** of MRSA colonization or infection is high; or if the
infection is clinically severe.

Explanatory notes
*Risk factors for true infection with Pseudomonas aeruginosa include Immunocompromised status, Chronic
Kidney Disease, warm climate and frequent exposure of foot to water.

**The local prevalence of MRSA (i.e., percentage of all S. aureus clinical isolates in that locale that are
methicillin resistant) is high enough (perhaps 50% for a mild and 30% for a moderate soft tissue infection)
that there is a reasonable probability of MRSA infection.

Recommendations 17
 clinical pathway 3: Care of Acute Wound

Wound/Ulcer

Acute Chronic

Not Infected Infected

Simple Off-loading Rule out Osteomyelitis (PTB Separate Flowchart

dressings only test, X-ray) Take adequate specimen for [Clinical Pathway 3.1-
No antibiotics culture Assess patient’s clinical condition Care of Acute Wound]

Patient stable Patient unstable Wet Gangrene

No Sepsis Sepsis present

Oral Antibiotics AMPUTATION

Wound
Care/Dressings Hospitalization i.v.
antibiotics Glycaemic
control Debridement
Wound care/Dressings
Follow-up

Improvement No Improvement

Continue same No threat to life Threat to life present

Protective Footwear
after ulcer heals Periodic
Evaluation to prevent Evaluate further for Osteomyelitis,
recurrence PAD, Neuropathy, Charcot’s foot

18 The Diabetic foot | Prevention and management in India

 4.3.5e. Give an initial antibiotic course for a soft tissue infection of about 1–2
weeks for mild infections and 2–3 weeks for moderate to severe infections.
4.3.5f. Continue antibiotic therapy until, but not beyond, resolution of findings of
infection, but not through complete healing of the wound.
4.3.5g Administer parenteral therapy initially for most severe infections and
some moderate infections, with a switch to oral therapy when the
infection is responding.

4.1 WOUND CARE

4.4.1 Clean ulcers regularly with clean water or saline*, debride them when possible
in order to remove debris from the wound surface and dress them with a sterile,
inert dressing in order to control excessive exudate and maintain a warm, moist
environment in order to promote healing**.

Explanatory note:
*Clean water is boiled cooled water (distilled water)
** Do not use H2O2, EUSOL, etc

4.4.2 Select dressings principally on the basis of exudate control, comfort and cost.

4.4.3 Do not use antimicrobial dressings with the goal of improving wound healing or
preventing secondary infection.

4.4.4 Do not offer the following to treat diabetic foot ulcers, unless as part of a clinical trial:

• Electrical stimulation therapy, autologous platelet-rich plasma gel, regenerative

wound matrices and dalteparin.

• Growth factors (granulocyte colony-stimulating factor [G-CSF], platelet-

derived growth factor [PDGF], epidermal growth factor [EGF] and transforming
growth factor beta [TGF-β]).

• Hyperbaric oxygen therapy.

4.4.5 Consider dermal or skin substitutes as an adjunct to standard care when treating
diabetic foot ulcers, only when healing has not progressed and on the advice of the
multidisciplinary foot care service.

Recommendations 19
 clinical pathway 3.2: Care of Chronic Wound

Chronic Wound / Ulcer

(non healing for > 6 weeks)

Assess Check for LOPS Assess for Gross

Vascularity (Loss of Protective Sensation) Osteomyelitis Deformities

Palpate pedal
pulses Calculate
Inability to feel the
ABI Arterial Colour Therapeutic
10-gm monofilament
Doppler Footwear

No
Neuropathy present relief

Corrective surgery
PAD present Off-loading
Protective Footwear

PTB test Inconclusive

X-ray High Suspicion

Patient moribund Patient Fit for Surgery

Microangiopathy Large vessel disease
Confirmed MRI
MR Angio / CT Osteomyelitis
Angio DSA

Medical Plan for Hospitalization

management Revasularisation i.v. antibiotics for 4-6 weeks
Debridement & Dressings
Off-loading

Protective Footwear after cure

20 The Diabetic foot | Prevention and management in India

4.4.6 Consider negative pressure wound therapy after surgical debridement for diabetic
foot ulcers, on the advice of the multidisciplinary foot care service.

4.4.7 Do not select agents reported to improve wound healing by altering the biology of
the wound, including growth factors, bioengineered skin products and gases, in
preference to accepted standards of good quality care.

4.4.8 Do not select agents reported to have an impact on wound healing through alteration
of the physical environment, including through the use of electricity, magnetism,
ultrasound and shockwaves, in preference to accepted standards of good
quality care.

4.4.9 Do not select systemic treatments reported to improve wound healing, including
drugs and herbal therapies, in preference to accepted standards of good quality
care. Redistribution of pressure off the wound to the entire weight-bearing surface
of the foot (“off-loading”). While particularly important for plantar wounds, this is
also necessary to relieve pressure caused by dressings, footwear, or ambulation to
any surface of the wound.

4.4.11 When deciding about wound dressings and offloading when treating diabetic foot
ulcers, take into account the clinical assessment of the wound and the person’s
preference, and use devices and dressings with the lowest acquisition cost
appropriate to the clinical circumstances.

4.5 FOOTWEAR
4.5.1 To heal a neuropathic plantar forefoot ulcer without ischemia or uncontrolled
infection in a patient with diabetes, offload with a non-removable knee-high device
with an appropriate foot-device interface.

Non-removable (cast) walker: Same as removable (cast) boot/walker but then with
a layer (s) of fibreglass cast material circumferentially wrapped around it rendering
it irremovable (also known as “instant total contact cast”)

4.5.2 When a non-removable knee-high device is contraindicated or not tolerated by the

patient, consider off loading with a removable knee-high walker with an appropriate
foot-device interface to heal a neuropathic plantar forefoot ulcer in a patient with
diabetes, but only when the patient can be expected to be adherent to wearing the
device.

Recommendations 21
 Removable (cast) boot/walker: Prefabricated removable knee-high boot with
a rocker or roller outsole configuration, padded interior, and an insertable and
adjustable insole which may be total contact.

4.5.3 When a knee-high device is contraindicated or cannot be tolerated by the patient,

consider offloading with a forefoot offloading shoe, cast shoe, or custom-made
temporary shoe to heal a neuropathic plantar forefoot ulcer in a patient with
diabetes, but only and when the patient can be expected to be adherent to wearing
the shoes.

4.5.4 Instruct an at-risk patient with diabetes to wear properly fitting footwear to prevent
a first foot ulcer, either plantar or non-plantar, or a recurrent non-plantar ulcer.
When a foot deformity or a pre-ulcerative sign is present, consider prescribing
therapeutic shoes, custom-made insoles, or toe orthosis*.
*Toe orthosis:- An in-shoe orthosis to achieve some alteration in the function of the toe.

4.5.5 To prevent a recurrent plantar foot ulcer in an at-risk patient with diabetes,
prescribe therapeutic footwear that has a demonstrated plantar pressure relieving
effect during walking and encourage the patient to wear this footwear.

4.5.6 Instruct a patient with diabetes not to use conventional or standard therapeutic
footwear to heal a plantar foot ulcer.
Explanatory note: Use footwear with following features:

Sandals: Should have adjustable straps, insole, full heel counter and rigid outsole.

Shoes: Should have wide toe box extra depth and without laces.

4.5.7 Consider using shoe modifications, temporary footwear, toe spacers or orthoses to
offload and heal a non-plantar foot ulcer without ischemia or uncontrolled infection
in a patient with diabetes. The specific modality will depend on the type and location
of the foot ulcer.

4.5.8 If other forms of biomechanical relief are not available, consider using felted foam*
in combination with appropriate footwear to offload and heal a neuropathic foot
ulcer without ischemia or uncontrolled infection in a patient with diabetes.

Felted foam - A fibrous, unwoven material backed by foam with absorbing and
cushioning characteristics. The foam is generally ‘rubber foam’ or ‘PU foam’ which
is formed by either a polyester or polyether polyol resin, in conjunction with water

22 The Diabetic foot | Prevention and management in India

 and Toluene di Isocyanate, along with various catalysts and blowing agents and
colouring pigments to give the desired compression.

4.6 Treatment of Diabetic foot with osteomyelitis

4.6.1 For an infected open wound, perform a probe-to-bone test; in a patient at low risk
for osteomyelitis a negative test largely rules out the diagnosis, while in a high risk
patient a positive test is largely diagnostic.

4.6.2 Markedly elevated ESR is suggestive of osteomyelitis in suspected cases.

Explanatory note: Tests for serum inflammatory markers are costly and not widely available, except ESR. Also
these tests are not diagnostic of DFO .

4.6.3 If osteomyelitis is suspected in a person with diabetes but is not confirmed by initial
X-ray, consider an MRI to confirm the diagnosis. In places where MRI is unavailable,
diagnose osteomyelitis by the PTB test (clinically) and/or taking a Bone biopsy and
culture.
Explanatory note: “Expert Consensus says that as availability of MRI is limited across the country, it is
recommended to use MRI wherever available.” At the primary and secondary health centre levels, the PTB
test and bone biopsy and culture are more feasible and economical and reasonably accurate.

4.6.4 A definite diagnosis of bone infection usually requires positive results on both
histological and microbiological examinations of an aseptically obtained bone
sample, but this is usually required only when the diagnosis is in doubt or determining
the causative pathogen’s antibiotic susceptibility is crucial.

4.6.5 Avoid using results of soft tissue or sinus tract specimens for selecting antibiotic
therapy for osteomyelitis as they do not accurately reflect bone culture results.

4.6.6 When a radical resection leaves no remaining infected tissue*, we suggest prescribing
antibiotic therapy for only a short duration (2–5 days). When there is persistent
infected or necrotic bone, we suggest prolonged (≥4 weeks) antibiotic treatment.
Explanatory note: *A proximal bone histopath to be done if available to get a clear margin and confirm that no
infected bone remains.

4.6.7 For specifically treating Diabetic foot osteomyelitis, we do not currently support
using adjunctive treatments such as hyperbaric oxygen therapy, growth factors
(including granulocyte colony stimulating factor), maggots (larvae), or topical
negative pressure therapy (eg, vacuum-assisted closure).

Recommendations 23
4.7 Charcot’s Foot
4.7.1 Suspect acute Charcot arthropathy if there is redness, warmth, swelling or deformity
(in particular, when the skin is intact), especially in the presence of peripheral
neuropathy or renal failure. Think about acute Charcot arthropathy even when
deformity is not present or pain is not reported.

4.7.2 Refer the person with suspected charcot’s foot early (within one week) to the
“Diabetic Foot Care Center” to confirm the diagnosis, and offer non-weight-bearing
treatment until definitive treatment can be started.

Diabetic Foot care centre:- In India, since there are no minimum standards of
services offered to the diabetic foot patients, in our recommendations we have used
this term to denote this facility, which may exist at the General Practitioner’s office,
Primary health centre, Secondary care centre or at a tertiary care centre. Preferably,
the diabetic foot care centre should consist of atleast a surgeon, a physician, and an
orthotist.

4.7.3 If acute Charcot arthropathy is suspected, X-ray the affected foot. Consider an MRI
if the X-ray is normal but clinical suspicion still remains.

4.7.4 Distinguishing the bony changes of osteomyelitis from those of the less common
entity of diabetic neuro-osteoarthropathy (Charcot foot) may be particularly
challenging and requires considering clinical information in conjunction with
imaging.

4.7.5 Clinical clues supporting neuro-osteoarthropathy in this context include midfoot

location and absence of a soft tissue wound, whereas those favoring osteomyelitis
include presence of an overlying ulcer (especially of the forefoot or heel), either
alone or superimposed on Charcot changes.

4.7.6 If the films show classic changes suggestive of osteomyelitis (cortical erosion,
periosteal reaction, mixed lucency, and sclerosis), and if there is little likelihood
of neuro-osteoarthropathy, it is reasonable to initiate treatment for presumptive
osteomyelitis, preferably after obtaining appropriate specimens for culture.

4.7.7 If the Diabetic Foot Care Center suspects acute Charcot arthropathy, offer
treatment with a non-removable off-loading device. Only consider treatment with
a removable off-loading device if a non-removable device is not advisable because
of the clinical or the person’s circumstances.

24 The Diabetic foot | Prevention and management in India

Clinical Pathway 3.3: Management of Charcot’s Foot

CHARCOT’S FOOT

Suspected when: Long-standing Diabetes, in the setting of peripheral

Swollen joint, Redness, neuropathy and/or CKD Warmth & Intact skin

Refer to Higher Centre

X-ray Inconclusive
High Suspicion

Confirmed
Charcot’s Foot MRI

Acute Chronic

Off-loading for 4-6 months Foot Unstable Foot Stable

Bracing Orthosis Therapeutic

Monitor for Resolution by Custom-made shoes Footwear Patient
• Serial X-rays Education
• Skin temperature Periodic
difference between Evaluation to
Convert to
both legs prevent
Stable Foot
recurrence

Foot remains Unstable not

Once quiescent, responsive to Off-loading Ulcer recurs
treat as Chronic and Immobilization

Treat
Consider Surgical Stabilization appropriately
as per flowchart
of ulcer
Remains Unstable Chronic
Ulceration Chronic Osteomyelitis

Consider AMPUTATION

Recommendations 25
4.7.8 Do not offer bisphosphonates to treat acute Charcot arthropathy, unless as part of
a clinical trial.

4.7.9 Monitor the treatment of acute Charcot arthropathy using clinical assessment. This
should include measuring foot–skin temperature difference and taking serial X-rays
until the acute Charcot arthropathy resolves. Acute Charcot arthropathy is likely to
resolve when there is a sustained temperature difference of less than 2˚ centigrade
between both feet and when X-ray changes show no further progression.

4.7.10 The Diabetic Foot care centre should care for people who have a foot deformity
resulting from a previous Charcot’s arthropathy as they are at high risk of ulceration.

4.8 SURGICAL INTERVENTIONS AND REVASCULARIZATION

4.8.1 Consult a surgical specialist in all cases of diabetic foot infections that are moderate
or severe.

4.8.2 Perform urgent surgical intervention in most cases of deep abscesses, compartment
syndrome and virtually all necrotizing soft tissue infections.

4.8.3 Debride any wound that has necrotic tissue or surrounding callus; the required
procedure may range from minor to extensive.

4.8.4 Perform urgent surgical intervention for most foot infections accompanied by gas
in the deeper tissues, an abscess, or necrotizing fasciitis, and less urgent surgery for
wounds with substantial nonviable tissue or extensive bone or joint involvement.

Additional note: In those with a non-severe infection, carefully observing the

effectiveness of medical therapy and the demarcation line between necrotic and
viable tissue before operating may be prudent.

4.8.5 Consider surgical intervention in cases of osteomyelitis accompanied by: spreading

soft tissue infection; destroyed soft tissue envelope; progressive bone destruction
on X-ray; or, bone protruding through the ulcer.

4.8.6 Remove slough, necrotic tissue & surrounding callus with sharp debridement in
preference to other methods, taking relative contraindications such as severe
ischemia into account.

4.8.7 Consider digital flexor tenotomy to prevent a toe ulcer when conservative treatment
fails in a high-risk patient with diabetes, hammer toes and either a pre-ulcerative
sign or an ulcer on the toe.

26 The Diabetic foot | Prevention and management in India

4.8.8 Consider Achilles tendon lengthening, joint arthroplasty, single or pan metatarsal
head resection or osteotomy to prevent a recurrent foot ulcer when conservative
treatment fails in a high-risk patient with diabetes and a plantar foot ulcer.

Management of Peripheral Artery Disease in patients with Diabetic foot problems

4.8.9 Examine a patient with diabetes annually for the presence of peripheral artery
disease (PAD); this should include, at a minimum, taking a history and palpating foot
pulses.

4.8.10 Evaluate a patient with diabetes and a foot ulcer for the presence of PAD. Determine,
as part of this examination, ankle or pedal Doppler arterial waveforms; measure
both ankle systolic pressure and systolic ankle brachial index (ABI).

4.8.11 Use bedside non-invasive tests to exclude PAD. No single modality has been
shown to be optimal. Measuring ABI (with <0.9 considered abnormal) is useful
for the detection of PAD. Tests that largely exclude PAD are the presence of
ABI 0.9-1.3, toe brachial index (TBI) ≥0.75 and the presence of triphasic pedal
Doppler arterial waveforms.

4.8.12 In patients with a non-healing ulcer with either an ankle pressure <50mmHg or ABI
<0.5 consider urgent vascular imaging and revascularisation.

4.8.13 Consider vascular imaging and revascularisation in all patients with a foot ulcer in
diabetes and PAD, irrespective of the results of bedside tests, when the ulcer does
not improve within 6 weeks despite optimal management.

4.8.14 Do not consider Diabetic microangiopathy to be the cause of poor wound healing in
patients with a foot ulcer.

4.8.15 To obtain anatomical information when revascularisation is being considered, use

one of these tests - Colour Doppler ultrasound, CT-angiography, MR-angiography or
intra-arterial digital subtraction angiography. Evaluate the entire lower extremity
arterial circulation, with detailed visualization of below-the-knee and pedal
arteries.

4.8.16 Offer duplex ultrasound as first-line imaging to all people with peripheral arterial
disease for whom revascularization is being considered. Take the decision of
revascularisation on the basis of colour doppler findings and use DSA for defining
the vascular anatomy prior to the procedure.

Recommendations 27
4.8.17 The aim of revascularisation is to restore direct flow to at least one of the foot
arteries, preferably the artery that supplies the anatomical region of the wound,
and adequate revascularization should be assessed post-operatively with colour
Doppler wave-fronts (preferable) or a hand held Doppler probe used bedside.

4.8.18 A centre treating patients with a foot ulcer in diabetes should have liaison /
association with a centre having the expertise necessary to diagnose and treat PAD;
both endovascular techniques and bypass surgery should be available.

4.8.19 The multidisciplinary team should treat the patient after a revascularisation
procedure for a foot ulcer in diabetes, as part of a comprehensive care plan.

4.8.20 There is inadequate evidence to establish which revascularisation technique

is superior and a multidisciplinary team should decide the technique of
revascularization for a patient based on a number of individual factors, such as
morphological distribution of PAD, availability of autogenous vein, patient co-
morbidities and local expertise.

4.8.21 Give emergency treatment to patients with signs of PAD and a foot infection as they
are at particularly high risk for major limb amputation.

4.8.22 Avoid revascularisation in patients in whom, from the patient perspective, the risk-
benefit ratio for the probability of success is unfavourable*.
*Explanatory note: Unfavorable risk benefit ratio would indicate those patients who are frail, elderly, bed
ridden, having low life expectancy, multiple co-morbidities imposing high risk for surgical intervention, etc.

4.8.23 All patients with diabetes and an ischemic foot ulcer should receive aggressive
cardiovascular risk management including support for cessation of smoking,
treatment of hypertension and prescription of a statin as well as low-dose aspirin or
clopidogrel.

4.8.24 Do not offer major amputation to people with critical limb ischaemia unless all
options for revascularisation have been considered by a vascular multidisciplinary
team. Major amputation without giving a chance for revascularization is indicated
only in lifesaving situations like foot causing septicemia, wet gangrene, or completely
destroyed foot (post charcot’s or osteomyelitis etc).

28 The Diabetic foot | Prevention and management in India

 Guideline Development Process

Background
A Task Force was constituted in December 2014 to guide the development of Standard
Treatment Guidelines (STG) in India. The Task Force subsequently approved the draft STG
development manual of India (Part 1) for development of adapted guidelines. A subgroup of the
task force was appointed to select prioritized topics for STG development and it recommended
a list of 14 topics which were then approved by the Task Force.” These 14 topics are from 10
clinical specialties for which the first set of STGs will be developed. The topic diabetic foot is
included in this first list and was ealt with by the General Surgery clinical subgroup.

Overview
The STG on Diabetic foot management, was developed by a team of experts and relevant
stakeholders. The recommendations in the STG were adopted/adapted from four source
guidelines which are the IWGDF (2015), IDSA (2012) and NICE guideline (26th August,
2015) on diabetic foot, and the NICE guidelines on PAD (Peripheral Arterial Disease)
November 2014.

Available from and full reference below:

http://www.iwgdf.org/files/2015/

http://www.idsociety.org

https://www.nice.org.uk/guidance/NG19

https://www.nice.org.uk/guidance/cg147

Guideline Development Process 29

 1. 2012 Infectious Diseases Society of America Clinical Practice Guideline for the
Diagnosis and Treatment of Diabetic Foot Infections

2. The National Institute for Health and Care Excellence (NICE) guidelines-
Diabetic foot problems: prevention and management (NG19) (Published: 26
August 2015)

3. International Working Group on the Diabetic Foot (IWGDF) 2015 - Prevention

and Management of Foot Problems in Diabetes Guidance Documents and
Recommendations

4. NICE guideline- Lower limb peripheral arterial disease: diagnosis and

management (NICE clinical guideline 147) (Issued: August 2012 last modified:
August 2015)

The processes and methods used in developing this STG draw on those outlined in the
STG development manual of India (Part 1) for development of adapted guidelines and
summarized in the Stepwise guide on STG development. The figure below contains
a schematic of the process followed and each of the steps are detailed in subsequent
sections below.

The NHSRC with technical support from NICE Iternational carried out a training
workshop in May 2015 to guide the STG group members and chairs on the methodology
to follow in developing adapted STGs suitable for the Indian context. This workshop
was conducted on 29th & 30th May, 2015 and two members (NR, MK) of the surgery
STG team attended. Subsequently, NHSRC facilitated the STG development process
by providing resources approved by the Ministry of Health &Family Wlfare to the
expert group.

To assist widespread implementation of the diabetic foot STG, three implementation

tools have been developed in addition to the STG document. They include:

yy The Quick Reference Guide to help the clinical practitioner (Clinical

pathways)
yy “A Patient Information Document to create awareness among the patients and
their caregivers.
yy the Quality Standards developed from key priority recommendations.

30 The Diabetic foot | Prevention and management in India

 1 Establish STG Group &
conduct STG meetings Capacity
to adapt

2
Scope the STG
Relevance
to Topic
3 Search and Select Recently
guidelines Published
Outcomes
Considered
Considerd Guideline
4 synthesis
Compare and sift
Evidence
rating guidelines
Local Topic
Population Priorities
and Setting 5 Search and select
Context
recommendation

Resources
Factor for
adoption
1
6 Adopt 1
6 Adapt Record
Technical Review Edit/reword � Exclusions
recommendations recommendations & reasoning
individually & and document � Rationale
Cultural
transfer verbatim changes for rewording
to new guideline
Resources

1 Review
9

1 Compile adopted & adapted

7
recommendations
1
8 External
NEW STG
(Background doc & Consultation/
implementation tools) peer review

Guideline Development Process 31

Steps followed during the development of the STG on diabetic foot
are as follows:

Diabetic foot STG Subgroup established

A multi-disciplinary group consisting of health professionals, subject matter experts in
various fields and a patient representative undertook the development of this evidence-
based STG on diabetic foot. Official letters of invitation were sent from the NHSRC head
office. The members of the task force who worked for the Government experienced
delays and difficulties in procuring permissions from their respective departments for
this work. Subsequently, there were drop outs and new experts invited. The names of
the 14 group members in the STG sub-group on diabetic foot, their specialities and
organization affiliation are listed here:

Task Force: The STG Subgroup on Diabetic foot

None of the members report any conflict of interest in the development of this guideline
and all have signed their declarations.

Facilitator Nobhojit Roy, Prof & Head, Dept of Surgery, BARC hospital (HBNI
University), Mumbai

Rapporteurs/ Monty Khajanchi, Assistant Prof, Dept of Surgery, KEM Hospital and G S
Writing team Medical college, Mumbai
Satish Mishra, Associate Prof, Dept of Surgery, BARC Hospital, (HBNI
University), Mumbai
KunalChhatbar, Replace Senior registrar with “Senior Resident”., Jagjivan
Ram Hosptial, Mumbai
Dikpal Singh Jadhav, PGRMO, BARC Hospital, (HBNI University), Mumbai
Aditi S Kashikar, MGIMS Wardha (Research assistant)

Expert Arun Bal, President, Diabetic Foot Association of India and Raheja Hospital
for Diabetes.

Physician Usha Menon, Prof of Clinical Endocrinology,

Amrita Institute of Medical Sciences, Kochi-682041, Kerala, India.

Private Sanjay Vaidya, Plastic surgeon, Hinduja Hospital

Practitioner DFSI Exec committee member

32 The Diabetic foot | Prevention and management in India

 Paramedic GauthamGopalakrishna,Principal senior Scientist & Head, Footwear
/Nurse/ Design and Development, Central Leather Institute, Chennai
Rehabilitation
Experts

Primary Care TruptiPatil, Chembur CHSS dispensary, Chembur, Mumbai

Practitioners

Patient Right Raman Kataria, Surgery, Jan SwasthyaSahyog, Ganiyari Village, Bilaspur
Group/NGO District, Chhattisgarh
Nandakumar M, Senior secondary care surgeon, Ashwini, Gudalur, Tamil
Nadu
SushilPatil, JSS, Ganyari, Chattisgarh

Expert Adviser
Dr. Raghuram Sekhar, Vascular surgeon, Kokilaben Dhirubhai Ambani Hospital, Mumbai
Dr Abha Mehndiratta was the technical person providing oversight and guidelines in
the meetings. Satish Mishra and Sushil Patil were the patient right representatives in
the group.

The STG Subgroup met twice face-to-face and all meetings (including the smaller weekly
ones were quorate (50%=7 members). The working group met every tuesday evening,
before and after each of these meetings over a period of two months. Some of the members
joined the small group meetings via video-conference. In the induction and orientation
session held on 21st July 2015, the facilitator (Chair) welcomed all the members of the
subgroup, and set up the rules of operation based on the STG development manual, on
the consistent use of terminology and definitions, using the structured powerpoint
presentation provided by NHSRC/NICE.

The induction and orientation session was held on 21st July 2015 in which the facilitator
(Chair) welcomed all the members of the subgroup, and set up the rules of operation based
on the STG development manual, on the consistent use of terminology and definitions,
using the structured power-point presentation provided by NHSRC/NICE.The STG
Subgroup met face-to-face twice between July 2015 to November 2015. The writing team
met every week, on Tuesday evening during the same time period. All these meetings were
quorate (50% = 7 members). Those who could not attend physically joined in via video
conferencing (Skype). Also, the individual members in the writing team kept in touch via

Guideline Development Process 33

e-mails and Whatsapp. In the initial few meetings the recommendations were drafted, and
in the subsequent meetings, the recommendations were edited as per the peer review
comments from the NHSRC/NICE.

34 The Diabetic foot | Prevention and management in India

Note
Note
 HEALTH M
AL
NATION

ISSI N
O

MINISTRY OF HEALTH AND FAMILY WELFARE

Government of India
Nirman Bhawan, New Delhi