Status:
UNKNOWN
External Shoe Lift to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers
Lead Sponsor:
Universidad Complutense de Madrid
Conditions:
Diabetic Foot Ulcer
Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04117269
Start Date
November 15 2019
End Date
December 1 2023
Last Update
May 18 2022
Active Locations (1)
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1
Diabetic foot Unit Complutense University
Madrid, Spain, 28040