Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons With Diabetes and Remission — Diatime  

Diabetic Foot Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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 4-6 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.

Clinical Trial 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 two weeks.

• Group 2: patients revised every four weeks.

• Group 3: patients revised every six weeks.

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. ;

Related Conditions & MeSH terms

• Diabetic Foot

• NCT number: NCT06143215
• Study type: Interventional
• Source: Universidad Complutense de Madrid
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Completion date: February 15, 2025