Status:
COMPLETED
Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons with Diabetes and Remission
Lead Sponsor:
Universidad Complutense de Madrid
Conditions:
Diabetic Foot
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this three arms randomized clinical trial is to compare different revision times in persons with diabetes at high risk of suffering a diabetic foot reulceration (patients in remission). Th...
Detailed Description
The planned RCT try to elucidate if there exist any difference in ulcer recurrence between different revisions times in persons with a previous healed diabetic foot ulcer and currently under remission...
Eligibility Criteria
Inclusion
- Patients aged 18 years or older.
- Type 1 or type 2 diabetes.
- Presence of diabetic polyneuropathy (diagnosed as an inability to sense the pressure of a 10-g Semmes-Weinstein monofilament at three plantar foot sites and/or a vibration perception threshold \>25 V, as assessed using a bio-tensiometer.
- Patients classified as high-risk patients (risk 3 patients according to the IWGDF guidance). Previous healed diabetic foot ulcer.
Exclusion
- Active diabetic foot ulcers during inclusion.
- Active Charcot foot process.
- Conditions other than diabetes also associated with foot ulcers were excluded from the study as well.
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2025
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT06143215
Start Date
January 10 2024
End Date
February 15 2025
Last Update
March 19 2025
Active Locations (1)
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1
Clínica Universitaria de Podología de la Universidad Complutense de Madrid
Madrid, Madrid, Spain, 28040