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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04117269
Other study ID # 19/337-E
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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