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

Not Applicable

• Conditions: Treatment Adherence and Compliance; Diabetic Foot Ulcer; Peripheral Neuropathy
• Interventions: Device: External shoe lift

• Registration Number: NCT04117269
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-07
• Study Start: 2019-11-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External shoe lift	External shoe lift	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).

Primary Outcome Measures

Name	Time	Method
Percentage of diabetic foot ulcers healed	12 weeks	Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate

Secondary Outcome Measures

Name	Time	Method
Time to healing	30 weeks	Time in weeks of diabetic foot ulcer healing
Percentage of diabetic foot ulcers healed	20 weeks	Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate
Adherence to offloading device	3 days	Two pedometer will be used (one inside the vendaje and the other into the offloading device)

Trial Locations

Locations (1)

Diabetic foot Unit Complutense University; 🇪🇸 Madrid, Spain