Malaysian clinical practice guidelines for management of diabetic foot: A synopsis for the primary care physician

Abstract

Diabetic foot requires careful attention and coordinated management by a dedicated team. Screening, prevention, adequate assessment, and appropriate referral are crucial to prevent complications. Multimodal treatment and rehabilitation are recommended to ensure a better quality of life and reduction of amputation rate in people with diabetic foot.

Introduction

Diabetic foot is defined as infection, ulceration, or destruction of tissues of the foot associated with neuropathy and/or peripheral arterial disease (PAD) of people with diabetes mellitus (DM).¹

According to the Malaysian National Health and Morbidity Surveys, the prevalence of diabetes has been increasing from 11.6% in 2006 to 15.2% in 2011 and further to 17.5% in 2015. The prevalence increased across age groups from 5.5% among those 18 to 19 years of age to a peak of 39.1% among those 70 to 74 years of age.² Overall, the cost of management of type 2 DM (T2DM) in 2011 was RM1.40 billion, which corresponded to 9.21% of the entire Ministry of Health (MoH) budget.³

The high prevalence of diabetes in adults increases the risk of foot problems, mainly due to neuropathy and/or PAD.⁴ Up to 50% of people with DM are asymptomatic of diabetic peripheral neuropathy (DPN)5 and about one million amputations are performed on people with diabetes each year worldwide.¹ Diabetic foot requires careful attention and coordinated management, preferably by a multidisciplinary foot care team.

Methods of Clinical Practice Guidelines Development

The evidence-based Clinical Practice Guidelines (CPG) on Management of Diabetic Foot (Second Edition) were developed by a multidisciplinary Development Group from the MoH and Ministry of Education, guided by a multidisciplinary Review Committee. A systematic review method was used, starting with a protocol including objectives and clinical questions. Then a systematic literature search was carried out primarily using the Medline and Cochrane Systemic Review databases. The reference lists of all retrieved literature and guidelines were also searched to identify relevant studies. Experts in the field were also contacted for further relevant studies. References were also made to other existing CPGs on diabetic foot.

All literature retrieved were appraised using Critical Appraisal Skill Programme checklist, presented in evidence tables, and further discussed in each Development Group meeting. All statements and recommendations formulated were agreed upon by both the Development Group and Review Committee. Where evidence was insufficient, the recommendations were made using the expert opinion of the teams. The CPG was largely based on the findings of systematic reviews or meta-analyses and clinical trials, with local practices taken into consideration. The level of evidence was based on the US/Canadian Preventive Services Task Force Level of Evidence, while the grading of recommendation used the principles of Grading Recommendations, Assessment, Development, and Evaluation (GRADE). The writing of the CPG followed strictly the requirement of Appraisal of Guidelines for Research and Evaluation (AGREE) II.

On completion, the draft of the CPG was reviewed by external reviewers and posted on the MoH Malaysia official website for any interested parties to give feedback. The draft was finally presented to the Technical Advisory Committee for CPG, and the Health Technology Assessment and CPG Council MoH Malaysia for final review and approval. The manuscript was then written based on the approved CPG as mentioned in Supporting Information section.

Diagnosis and Assessment

All people with diabetes should be assessed for diabetic foot at risk. They should be screened, diagnosed, investigated, classified, and stratified to ensure optimal management. Assessment of DPN should be performed at diagnosis and repeated annually.⁶ Early detection of diabetic foot at risk and appropriate interventions will minimize complications and healthcare costs.⁷

History Taking

Proper management of diabetic foot is initiated by good history taking, which includes general (risk factors for diabetic foot), medical (underlying concurrent medical condition), and individual diabetic foot history (vascular or neuropathic symptoms). Predictors for increased risk of foot ulceration in diabetes include a previous history of ulceration or lower extremity amputations and a longer duration of diabetes.⁸ Refer to the Diabetic Foot Assessment Form for full history taking on diabetic foot.

Physical Examination

Physical assessment is an important step in the screening and diagnosing of diabetic foot problems, including complications. This includes proper inspection and palpation of the foot.

• Skin

Skin changes due to vascular insufficiency may be present, for example, skin atrophy, nail atrophy, diminished pedal hair, prolonged capillary refill time (>2 seconds), and reduced skin temperature.

• Neurological

A monofilament test and vibration perception are used to assess DPN, which is a major independent risk factor for diabetic foot ulceration. It may involve large fiber nerves (for touch, vibration, position perception, and muscle control), small fiber nerves (for thermal perception, pain, and autonomic function), or both. The commonly used screening tools are:

Semmes-Weinstein Monofilament Examination

A Semmes-Weinstein monofilament examination (SWME) is easy to perform and widely available locally. The examination uses a 5.07/10-g monofilament which exerts a buckling force when it bends. Inability to sense touch or pressure (>3 out of 10 sites) indicates loss of protective sensation. SWME should be combined with another modality in the screening of peripheral neuropathy. Refer to Figure 1.

Figure 1. Semmes-Weinstein monofilament examination (SWME).

Tuning Fork Test

A tuning fork is used to detect the loss of vibration sense. The most commonly used tuning fork is 128 Hz. Refer to Figure 2.

Figure 2. Tuning fork examination.

Neuropathy should be assessed with 10-g monofilament and one other modality (e.g. pin prick, vibration sense with 128 Hz tuning fork, etc.). These increase the sensitivity of detecting peripheral neuropathy by 87%.⁶

• Vascular

Vascular assessment includes mandatory palpation of the femoral, popliteal, posterior tibial, and dorsalis pedis artery pulses. Critical limb ischemia is defined as rest pain with ulcers or tissue loss attributed to arterial occlusive disease. It is associated with substantial loss of limb and life.⁹

Palpation of foot pulses should be the initial screening method for PAD. Among the tests that can be used to exclude PAD are¹:

• Ankle-brachial index (normal value 0.9—1.3)

• Toe-brachial index (normal value ≥0.75)

• Continuous wave Doppler (presence of triphasic waveforms)

Thus’ screening for DPN and PAD should be performed on all patients with diabetes at diagnosis and repeated at least annually. Those with DPN and PAD should be referred appropriately. Refer to Algorithm A.

Algorithm A. Screening of diabetic foot.

• Musculoskeletal

Musculoskeletal complications in diabetic foot include ulcers, infections, and deformities (e.g. Charcot neuroarthropathy).

Conventional radiography may be helpful in diabetic foot for initial imaging to detect osteolysis, arterial calcification, gas shadow, malalignment, and peri-articular fragmentation.

Refer to the Diabetic Foot Assessment Form for the full physical examination of diabetic foot.

Diabetic Foot Assessment Form¹⁰

Risk Stratification

A patient’s current risk of developing a diabetic foot or requiring amputation is assessed using a practical risk stratification, as shown in Table 1.

Table 1. Diabetic foot risk stratification⁴.

Diabetic foot risk	Findings
Normal	No abnormalities
Low Risk	Callus alone
Moderate Risk	Any of the following: deformity neuropathy non-critical limb ischemia
High Risk	One of the following: previous ulceration previous amputation on renal replacement therapy neuropathy and non-critical limb ischemia neuropathy with callus and/or deformity non-critical limb ischemia with callus and/or deformity
Active Diabetic Foot Problem	Any of the following: ulceration infection critical limb ischemia gangrene suspicion of an acute Charcot neuroarthropathy, or an unexplained hot, red, swollen foot with or without pain

Classification

The University of Texas Classification¹¹ is the preferred classification for diabetic foot and is useful to decide on the further management of the diabetic foot (refer Table 2). Refer to Algorithm B.

Table 2. University of Texas classification of diabetic foot ulcers.

STAGE	GRADE 0	GRADE I	GRADE II	GRADE III
STAGE A	Pre- or post-ulcerative lesion completely epithelialized	Superficial wound, not involving tendon, capsule, or bone	Wound penetrating to tendon or capsule	Wound penetrating to bone or joint
STAGE B	With infection	With infection	With infection	With infection
STAGE C	With ischemia	With ischemia	With ischemia	With ischemia
STAGE D	With infection and ischemia	With infection and ischemia	With infection and ischemia	With infection and ischemia

Algorithm B. Active foot problems (with risk stratification).

Prevention

Patient education should be an integral part of the management of diabetic foot. It should be given at least annually and more frequently in higher-risk patients. Glycemic control (with minimization of hypoglycemia) should be individualized.

Patients should be advised on appropriate footwear according to the foot risk. Its importance increases with a higher risk of developing diabetic foot ulcer. Recommendations of footwear according to foot risk status are shown in Table 3.¹²

Table 3. Footwear advice¹².

Risk status	Actions
All foot at risk	Advise the use of footwear that fits, protects, and accommodates the shape of the feet (with socks).
Moderate or high risk	Prescribe footwear with: custom-made in-shoe orthoses or insoles for people with a foot deformity or pre-ulcerative lesions off-loading orthoses or insoles for people with healed plantar foot ulcer Review prescribed footwear periodically to ensure it still fits, protects, and supports the foot Advise the wearing of footwear at all times, both indoors and outdoors
Foot ulceration	Prescribe appropriate off-loading devices for ulcer healing

Patients with diabetic foot should be referred early for preventive surgery if all other modalities have failed. It should be performed by orthopedic surgeons trained in the procedures to prevent ulceration or re-ulceration in diabetic patients with foot deformity e.g. restricted ankle dorsiflexion, equinus contracture, claw toe, hammer toe, or mallet toe.

Treatment

• Pharmacotherapy

Appropriate analgesia should be considered in painful diabetic foot. In neuropathic pain, adjuvants are used at all steps of the analgesic ladder.¹³ Examples of adjuvants are antidepressants (e.g. amitriptyline or duloxetine) and anticonvulsants (e.g. gabapentin or pregabalin).¹⁴

Antibiotics should not be used unless there are local or systemic symptoms of infection. Local treatment including surgical debridement is important to be considered as part of the management. Antibiotic used for treatment should be based on the most recent culture and sensitivity report.¹⁵

In diabetic foot, antibiotics should be given according to the disease severity, care setting, patient’s preference, clinical situation and medical history. If more than one regimen is appropriate, the regimen with lowest cost should be selected. For moderate and severe infections, broad spectrum antibiotics are used initially until culture and sensitivity results are available. Antibiotics should not be given for⁴:

• prevention of infections in diabetic foot

• >14 days for the treatment of mild soft tissue infection in diabetic foot

• Wound Management

Wound Dressings

Advanced wound dressings may be offered in diabetic foot ulcer; refer to Table 4

Table 4. Types of wound dressing in diabetic foot¹⁶.

No.	Types of dressing	Advantages	Disadvantages	Indications	Contraindications	Review intervals
Basic wound contact dressings
1.	Gauze/basic absorbent with paraffin or similar (antiseptics or antibiotics)	Reduces adherence of dressing to the wound Widely available	Minimal exudate absorption Requires secondary dressing	All wounds	Allergy	Daily
Advanced wound dressings
1.	Hydrogel	Provides moist environment Acts as enzymatic debridement Promotes granulation	Requires secondary dressing	Sloughy wound Dry wounds	Highly exudative wounds Allergy	1-2 days
2.	Alginate	Forms gel on wound and maintain moisture Acts as cavity filler Absorbent in exudative wounds Promotes hemostasis Low allergenic	Requires secondary dressing Gel can be confused with slough or pus in wound	Moderately or highly exudative wounds Need for hemostasis	Dry wounds Allergy	2-3 days
3.	Hydrofibre	Maintains moisture Longer wear time Non-traumatic upon removal Reduces risk of maceration Can be used on infected wounds	Not helpful for dry wounds Requires secondary dressings	Moderately or highly exudative wounds	Allergy	2-5 days
4.	Foam	Maintains moisture Highly absorbent Cushioning property	Limited size	Moderately or highly exudative wounds	Dry wounds Wounds that need frequent review	2-3 days
5.	Hydrocolloid	Maintains moisture Cleans and debrides by autolysis Easy to use Waterproof	Induces peri-wound maceration	Mildly to moderately exudative wounds	Dry wounds Infection Highly exudative wounds	2-3 days
6.	Silver	No known resistance Bactericidal	Some silver dressings discolor the wound	Infective wounds	Allergy	3-5 days
7.	Others	Not widely used - some may be used in specialized centers e.g. collagen, matrix, and regenerative dressings (cultured epidermis, growth factors, stem cells, etc.)

Adjuvant Therapy

Adjuvant therapy may be offered in delayed wound healing in diabetic foot with good vascularity.

• Negative pressure wound therapy is a procedure in which a vacuum dressing is used to promote wound healing. It is used for clean exudative wounds with poor granulation.¹⁷

• Maggot debridement therapy is used for the debridement of wounds with necrotic tissue. It shows better wound closure (>50% of wound area) after 10 days compared with autolytic debridement with hydrogel in diabetic foot ulcer.¹⁸

• Hyperbaric oxygen therapy is used to increase oxygenation and antimicrobial effect that can improve the healing of chronic ulcers.^19–21

Revascularization

Revascularization should be offered in diabetic patients with PAD. Surgical debridement by trained healthcare providers should be considered in diabetic foot ulcer that fails to respond to non-surgical debridement, or is deep and infected at presentation.

Rehabilitation

Off-loading should be offered to people with plantar diabetic foot ulcer. Those with diabetic foot who have had amputation should be referred for rehabilitation.

Algorithms A and B summarize the management of diabetic foot.

Referral

People who are at moderate or high risk of developing a diabetic foot problem are referred to multidisciplinary professionals in the field of podiatry, diabetology, biomechanics and orthoses, and wound care.⁴ People with a limb-threatening or life-threatening diabetic foot problem should be referred urgently and managed under specialist care. Examples of such conditions include ulceration with fever or any signs of sepsis, critical limb ischemia, deep-seated soft tissue or bone infection, and gangrene.

The recommended referral schedule for diabetic foot is shown in Table 5

Table 5. Recommended referral schedule.

Diabetic foot risk	Findings
Normal/Low risk	No referral needed-yearly review at primary care
Moderate risk	Referral within 3 months to foot protection services
High risk	Early referral within 2 weeks to foot protection services
Active diabetic foot problem	Urgent referral within 24 hours to multidisciplinary foot care team

The referral should be addressed to:

1. The Foot Protection Service, which provides prevention and treatment of simple active diabetic foot problems in the community that do not require admission. The team should be led by a Family Medicine Specialist or physician with special training in diabetic foot problems and supported by podiatrist, diabetic team (including diabetic educator), wound care team, and rehabilitation services.

2. The multidisciplinary foot care service, which manages active or complicated diabetic foot problems in the hospital. The team is led by an orthopedic surgeon and/or physician. Subsequent referral to other specialties is made according to the main problem presented by the patient.

Monitoring and Follow-up

Frequency of monitoring of patients with diabetic foot depends on risk stratification as shown in Table 6 below:

Table 6. Frequency of Monitoring for Diabetic Foot.

Risk	Low risk	Moderate risk	High risk
			No immediate concern	Immediate concern
Frequency	Annually	3–6 months	1–2 months	1–2 weeks

Supporting Information

Details of the evidence supporting the above statements can be found in Clinical Practice Guidelines on the Management of Diabetic Foot (Second Edition) 2018, available on the following websites: http://www.moh.gov.my (Ministry of Health Malaysia) and http://www.acadmed.org.my (Academy of Medicine). Corresponding organization: CPG Secretariat, Health Technology Assessment Section, Medical Development Division, Ministry of Health Malaysia; contactable at htamalaysia@moh.gov.my.