N/A
N=41
Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers
Venous Leg Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT03796793 ↗Enrolled (actual)
41
Serious AEs
2.4%
Results posted
May 2026
Primary outcome: Primary: Change in the Genetic Profile After Debridement in the Intervention Group. — 1031 Number of Differentially Expressed Genes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Wound Edge Debridement (Procedure); Standard of Care Treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Genetic Profile After Debridement in the Intervention Group. |
1031 | — |
| SECONDARY Percent Rate of Healing Versus Non-healing Wounds Within Each Treatment Group |
62.5; 21.4; 37.5; 78.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- >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
Exclusion Criteria
- 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 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
- Skin ulcer previously treated within the last 4 weeks with biologic therapies (e.g. cell therapy or growth factors)
- if currently incarcerated
- known pregnancy
Data sourced from ClinicalTrials.gov (NCT03796793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.