An interventional study of 4 weeks revision in Diabetic Foot, sponsored by Universidad Complutense de Madrid. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Prevention
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). The literature suggests to clinically check the patients in a 4-12 weeks basis, despite this, this recommendation is based in expert opinions.
The main question it aims to answer is:
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.
There will exist three different groups for analyses after randomization:
Main outcome measure will include:
Secondary outcome measure will include:
Follow-up period: all the sample will be followed-up depending on the randomization group up to a 1-year prospective period. In every visit de principal investigator will perform debridement of high-risk points, such as minor lesions or calluses.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 148 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Universidad Complutense de Madrid is the lead sponsor of 200 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be clinically revised in a 4-weeks basis
Behavioral: 4 weeks revision
Patients will be clinically revised in a 8-weeks basis
Behavioral: 4 weeks revision
Patients will be clinically revised in a 12-weeks basis
Behavioral: 4 weeks revision
In the literature is described to clinically revise patients in a 4-6 weeks basis, despite this expert recommendation, no previous research has clinically evaluated if 4-8-12 weeks revision times could change diabetic foot reulceration rate.
Recurrence rate
Defined as as break in the foot skin at the epidermis and part of the dermis level.
Time frame: From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.
Minor lesion rate
Defined as non ulcerative lesions of the skin on the plantar aspect of the foot and included abundant callus, hemorrhage, or a blister.
Time frame: From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.
Minor amputation rate
Need for minor amputation secondary to ulcer recurrence
Time frame: From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Universidad Complutense de Madrid