NCT06143215

Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons with Diabetes and Remission

Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons with Diabetes and Remission: a Three Arm Double Blind Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). 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: \- Does different revision times could affect the reulceration rate in persons with diabetes in remission. Different revision time will be 2 weeks, 4 weeks and 6 weeks.

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. There will exist three different groups for analyses after randomization: * Group 1: patients revised every fourweeks. * Group 2: patients revised every eightweeks. * Group 3: patients revised every twelveweeks. Main outcome measure will include: \- Recurrence: the outcome measure was based on recurrent events in the foot in a binary basis (patient with a recurrent event or patient without a recurrent event), as defined according to the IWGDF guidelines. Recurrent events were considered as breaks in the foot skin at the epidermis and part of the dermis level. Secondary outcome measure will include: * Minor lesions: defined as non ulcerative lesions of the skin on the plantar aspect of the foot and included abundant callus, hemorrhage, or a blister. * Minor amputations: evaluated in a monthly basis during the 1-year prospective period 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.

Conditions

• Diabetic Foot

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-10
• Primary completion: 2024-12-09
• Completion: 2025-02-15
• First posted: 2023-11-22
• Last updated: 2025-03-19

Locations

1 site across 1 country: Spain