Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

NCT03796793 | Active Not Recruiting DMC

• 2 other identifiers: 20180256R01AR073614
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in the genetic profile after debridement in the intervention group.

  RNA sequencing will be used to determine the number of differentially expressed genes of the intervention group in samples collected pre-debridement to samples collected post-debridement.

  Baseline and 4 weeks

Secondary Outcomes (1)

• Percent rate of healing

  Up to 4 weeks

Study Arms (2)

Wound Edge Debridement Group

EXPERIMENTAL

Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.

Procedure: Wound Edge Debridement; Other: Standard of Care Treatment

Standard care group

ACTIVE COMPARATOR

Participants in this group will receive only the standard care of treatment for up to 4 weeks.

Other: Standard of Care Treatment

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.

Wound Edge Debridement Group

Standard of Care Treatment OTHER

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

Standard care group; Wound Edge Debridement Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Conformation of venous disease by non-invasive venous studies with either Doppler-confirmed venous reflux, or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclersosis, venous dermatitis, atrophie blanche, edema)
• have a venous ulcer between the knee and ankle, at or above the malleolus
• wound size would be greater than or equal to 5cm2 in area without exposed tendon, muscle or bone
• wound duration of at least 6 months
• VLU containing yellow/white slough with or without fibrous/scar tissue and/or non-viable tissue
• ability of subject to tolerate limb compression bandage

You may not qualify if:

• history of diabetes mellitus and a HbA1c \> 12% (obtained within past 6 months)
• Ankle brachial index(ABI) less than 0.80
• any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in remission for at least 5 years
• suspicion of malignancy within VLU
• life expectancy \<6 months
• history of kidney disease and creatinine greater than 2.0 (obtained within past 6 months)
• history of liver disease and liver function test (ALT, AST, ALK PHOS, and bilirubin) \>2x upper limit of normal (obtained within past 6 months)
• requirement for long-term systemic corticosteroids or immunosuppressive therapy, or history of corticosteroid or immunosuppressive use in the 4 weeks prior to study entry
• history of immunodeficiency
• ulcers due to none venous etiology and leg ulcers associated with mixed etiology
• Untreated osteomyelitis
• Hepatitis
• acute deep venous thrombosis
• allergy to lidocaine and/or epinephrine
• Subject's inability to successfully tolerate compression therapy that is changed weekly

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marjana Tomic-Canic, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Robert Kirsner, MD/PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chairman

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 8, 2019
• Study Start: March 18, 2019
• Primary Completion: February 13, 2025
• Study Completion: December 31, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)