Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

NCT03796793 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-05-14

Study results available
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Summary

The goal of this project is to use genomic profiling, candidate genes and proteins to develop guided surgical debridement to improve healing in chronic non-healing venous leg ulcers (VLUs) and to test the efficacy of this approach.

Conditions

  • Venous Leg Ulcer

Interventions

PROCEDURE

Wound Edge Debridement

Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base.

OTHER

Standard of Care Treatment

Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH
  • University of Miami

    lead OTHER

Principal Investigators

  • Marjana Tomic-Canic, PhD · University of Miami

  • Robert Kirsner, MD/PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-18
Primary Completion
2025-02-13
Completion
2025-03-25

Countries

  • United States

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 NCT03796793 on ClinicalTrials.gov