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

NCT06160817 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-05-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Universidad Complutense de Madrid

    lead OTHER

Principal Investigators

  • Francisco Javier Álvaro Afonso, Podiatrist · University Podiatry Clinic, "Universidad Complutense de Madrid"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2024-04-30
Completion
2024-05-06

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06160817 on ClinicalTrials.gov