What is the best approach for a patient with a history of diabetes and potential foot ulcers to be fitted with orthotics (orthopedic devices)?

Orthotic Fitting for Diabetic Patients with Potential Foot Ulcers

Primary Recommendation

For diabetic patients with a healed plantar foot ulcer (highest risk category), prescribe therapeutic footwear with demonstrated plantar pressure-relieving effects during walking, and strongly emphasize consistent wear both indoors and outdoors to prevent ulcer recurrence. 1

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Risk-Stratified Orthotic Approach

The optimal orthotic intervention depends entirely on the patient's current foot status and ulcer history:

For Patients WITHOUT Active Ulcers:

Low-Risk Patients (No deformity, no ulcer history):

• Educate to wear properly fitting footwear that accommodates foot shape with adequate length, width, and depth 1
• Standard commercial footwear is acceptable if it fits properly 1
• Instruct patients to check inside shoes for foreign objects before donning 1

Moderate-Risk Patients (Foot deformity OR pre-ulcerative lesions):

• Consider prescribing extra-depth shoes, custom-made footwear, custom-made insoles, and/or toe orthoses 1
• These interventions help redistribute plantar pressures away from high-risk areas 1
• When custom insoles are prescribed, extra-depth footwear must accommodate the increased thickness 1

High-Risk Patients (Healed plantar ulcer):

• Prescribe therapeutic footwear with documented plantar pressure reduction during walking 1, 2
• This is a strong recommendation with moderate-quality evidence for preventing recurrent ulceration 1
• Patient adherence is critical—emphasize wearing prescribed footwear continuously, both indoors and outdoors 1
• The recurrence rate after ulcer healing is 65% within 3-5 years without appropriate preventive footwear 3

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For Patients WITH Active Plantar Ulcers:

The International Working Group on the Diabetic Foot (IWGDF) 2024 guidelines provide clear hierarchical recommendations:

First-Line Treatment:

• Use a non-removable knee-high offloading device (total contact cast or non-removable walker) 1, 2
• This is a strong recommendation with moderate-quality evidence 1
• Non-removable devices ensure adherence, which is the primary reason for their superiority 2
• Choose between total contact cast (TCC) or non-removable knee-high walker based on local resources, clinician skills, and patient factors 1

Second-Line Treatment (if non-removable contraindicated):

• Use removable knee-high OR ankle-high offloading device 1
• Contraindications for non-removable devices include heavily exudating wounds, moderate infection, or patient refusal 1
• Critical caveat: Removable devices show little-to-no difference in healing rates compared to each other (RR 1.00,95% CI 0.86-1.16), but both are inferior to non-removable options 1
• Strongly encourage wearing during ALL weight-bearing activities 1

Third-Line Treatment (if devices unavailable):

• Consider felted foam combined with appropriately fitting footwear 1, 2
• This is the weakest evidence-based option but better than conventional footwear alone 1

What NOT to Use:

• Do not use conventional footwear or standard therapeutic footwear alone for active ulcer treatment 1
• This is a strong recommendation despite low-quality evidence, as these will not promote healing 1

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Special Populations

Patients with Charcot Neuro-Osteoarthropathy (CNO):

• After acute CNO treatment and achieving remission, prescribe footwear that accommodates and supports the deformed foot/ankle shape 1
• When deformity or joint instability is present, use below-knee customized devices (Charcot Restraint Orthotic Walker [CROW] or contoured plastic ankle-foot orthosis) 1
• This is a strong recommendation with moderate-quality evidence for preventing CNO reactivation 1

Patients with Infection or Ischemia:

• Mild infection or mild ischemia: Consider non-removable knee-high device 1
• Moderate infection or moderate ischemia: Use removable offloading device for easier wound monitoring 1, 2
• Severe infection or severe ischemia: Prioritize treating the infection/ischemia first, then use removable offloading based on individual factors 1

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Critical Implementation Points

Ensuring Adherence:

• Non-removable devices are superior specifically because they enforce compliance 2
• Patient adherence with removable devices is notoriously poor—do not rely on removable options unless you have strong evidence the patient will comply 2
• Studies show removable devices are often worn less than 30% of the time 2

Contralateral Limb Protection:

• Consider using a shoe lift on the contralateral limb when the patient wears a knee-high or ankle-high offloading device 1, 4
• This improves comfort, balance, and prevents contralateral plantar fasciitis or ulceration 4

Common Pitfalls to Avoid:

• Never allow patients to walk barefoot, in socks only, or in thin slippers during ulcer treatment—this prevents healing 2
• Do not assume therapeutic footwear alone will heal an active ulcer—offloading devices are required 1
• Do not prescribe custom orthotics without ensuring extra-depth footwear to accommodate them 1

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Patient Education Essentials

Regardless of orthotic type, educate patients to:

• Check inside footwear for foreign objects before each use 1
• Wear seamless socks of natural materials, preferably light-colored to detect drainage from pre-ulcerative lesions 1
• Inspect feet daily and report temperature differences >2.2°C between feet, which may indicate impending ulceration 1
• Understand that consistent footwear use is non-negotiable—the lifetime ulcer risk is 19-34%, and recurrence after healing is 65% within 3-5 years without proper prevention 3, 5

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Surgical Considerations for Refractory Cases

If conservative offloading fails after appropriate trial:

• For plantar metatarsal head ulcers: Consider Achilles tendon lengthening (strongest evidence) or metatarsal head resection 1, 2
• For hallux ulcers: Consider joint arthroplasty 1, 2
• For flexible toe deformities with ulcers on digits 2-5: Perform digital flexor tenotomy (strong recommendation with moderate evidence) 1, 2

All surgical interventions must be combined with continued offloading devices 1, 2