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

NCT04117269 | Unknown

• 1 other identifier: 19/337-E
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer; Peripheral Neuropathy; Treatment Adherence and Compliance

Outcome Measures

Primary Outcomes (1)

• Percentage of diabetic foot ulcers healed

  Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate

  12 weeks

Secondary Outcomes (3)

• Percentage of diabetic foot ulcers healed

  20 weeks

• Adherence to offloading device

  3 days

• Time to healing

  30 weeks

Study Arms (2)

External shoe lift

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

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

Interventions

External shoe lift DEVICE

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

External shoe lift

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Diabetic foot Unit Complutense University

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Peripheral Nervous System Diseases; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Neuromuscular Diseases; Nervous System Diseases; Health Behavior; Behavior

Central Study Contacts

Raúl Juan Molines Barroso, Phd

CONTACT

639059104; rauljmolines@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: November 15, 2019
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)