Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT03796793
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Wound Edge Debridement — PROCEDURE
    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.
  • Standard of Care Treatment — OTHER
    Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.

Study Details

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.

Key Dates

Start date
Mar 18, 2019
Status verified
Apr 2026
Primary completion
Feb 13, 2025
Completion
Mar 25, 2025

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Wound Edge Debridement Group
    Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.
  • Active Comparator: Standard care group
    Participants in this group will receive only the standard care of treatment for up to 4 weeks.

Primary Outcome Measure

Change in the Genetic Profile After Debridement in the Intervention Group. [ Time Frame: Baseline and 4 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-

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By research site
University of Miami· Miami, FL

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