External Shoe Lift to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers

Universidad Complutense de Madrid

Status: Unknown

Conditions: Peripheral Neuropathy; Treatment Adherence and Compliance; Diabetic Foot Ulcer

Treatments: Device: External shoe lift

Study type: Interventional

Funder types: Other

Identifiers

NCT04117269

19/337-E

Details and patient eligibility

About

Previous researches hipothesize that imposed limb-length discrepancies may discourage adherence in patients with active diabetic foot ulcer and using offloading devices. Our hipothesis is that the use of an external shoe lift contralaterally to the affected foot may improve adherence to offloading devices and improve healing.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Plantar diabetic foot ulcer.
• Wagner I and II classification.
• Ulcer area between 1-30 cm square centimeters.
• HbA1c values in the last three months below 11%
• Ankle brachial Index (ABI) value > 0.5.

Exclusion criteria

• Diagnosis of Critical Limb Ischaemia definid by TASCC II guideline.
• Presence of foot ulcer in both feet.
• Presence of soft tissue infection.
• Osteomyelitis suspicion.
• Peripheral neuropathy due to different causes than diabetes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

External shoe lift

Experimental group

Description:

Those patients allocated in the experimental group will be supplemented with a external shoe lift in the contralateral limb in their conventional shoes to compensate the differences with the affected foot (using a offloading device to active ulcer).

Treatment:

Device: External shoe lift

Standard of care

No Intervention group

Description:

Those patients allocated in the control group will not be supplemented, they will be treated with a standard of care treatment.