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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04117269
• Other study ID #: 19/337-E
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: Universidad Complutense de Madrid
• Contact: Raúl Juan Molines Barroso, Phd
• Phone: 639059104
• Email: rauljmolines[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Treatment Adherence and Compliance
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Spain	Diabetic foot Unit Complutense University	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of diabetic foot ulcers healed	Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate	12 weeks
Secondary	Percentage of diabetic foot ulcers healed	Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate	20 weeks
Secondary	Adherence to offloading device	Two pedometer will be used (one inside the vendaje and the other into the offloading device)	3 days
Secondary	Time to healing	Time in weeks of diabetic foot ulcer healing	30 weeks