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

Clinical Efficacy of an External Shoe Lift in the Contralateral Limb to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer; Peripheral Neuropathy; Treatment Adherence and Compliance
• Intervention / Treatment: Device: External shoe lift

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Diabetic foot Unit Complutense University
    • Sub-Investigator: Marta García-Madrid Martín de Almagro, Phd
    • Sub-Investigator: Mateo López Moral, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: External shoe lift; Height compensation will be made with cork or EVA (polyurethane + Ethylene Vinyl Acetate) depending the characteristics of the shoe. It will be made by the same orthophaedic technician. The prescription of the heigh of the lift will be made with the patient in a barefoot standing position, a calibre will be used to mark the femoro-tibial joint in both lower limbs in order to rule out the asymmetry. After this, the patient will shod the offloading device in the ulcerated feet and their conventional footwear in the other foot (with the use of their own foot orthosis). 5 millimeters splints will be added under the non affected footwear until the previous mark in both limbs been balanced. The difference in the heigh between limbs will be assessed measuring all the splints used previously
No Intervention: Standard of care; Those patients allocated in the control group will not be supplemented, they will be treated with a standard of care treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of diabetic foot ulcers healed	Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Neuromuscular Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Peripheral Nervous System Diseases
• Other Study ID Numbers: 19/337-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No