NCT06160817

Ulcer Location and Debridement Frequency: Weekly vs. Biweekly Sharp Debridement in Diabetic Foot Ulcers

Effect of Ulcer Location on Debridement Frequency: A Pilot Randomized Controlled Trial Comparing Weekly and Second-weekly Sharp Debridement in Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to determine the optimal frequency for sharp debridement in promoting the healing of diabetic foot ulcers (DFUs). The main questions it aims to answer are: 1. What is the comparative effect of weekly sharp debridement versus biweekly sharp debridement in combination with conventional treatment on granulation tissue and healing time in patients with DFUs? 2. What is the optimal modality or frequency of debridement based on the location of the DFU? Participants (ulcerated diabetic patients) will: * Undergo sharp debridement on a weekly basis (Group A). * Undergo sharp debridement on a biweekly basis (Group B). Researchers will compare Group A (weekly sharp debridement) with Group B (biweekly sharp debridement ) to see if the frequency of sharp debridement has a significant effect on granulation tissue and healing time in diabetic foot ulcers. In each group, there will be patients with ulcers in different locations (toes, metatarsal heads, and midfoot/hindfoot) to assess the effect of debridement based on the lesion location

Conditions

• Diabetic Foot Ulcer
• Diabetic Foot
• Wound Heal

Interventions

Type	Name	Description
PROCEDURE	Conservative sharp debridement	The debridement method for all patients, regardless of the assigned sequence, will involve the removal of non-viable tissue from the ulcer bed, edges, and perilesional skin using a scalpel (No. 3) with a No. 10 and/or No. 15 blade, along with Adson forceps and straight dissecting forceps.

Timeline

• Start date: 2024-01-11
• Primary completion: 2024-04-30
• Completion: 2024-05-06
• First posted: 2023-12-07
• Last updated: 2024-05-08

Locations

1 site across 1 country: Spain