Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Procedure: Wound Edge Debridement
* Other: Standard of Care Treatment


Participation Criteria
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Eligibility Criteria
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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 <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 Skin ulcer previously treated within the last 4 weeks with biologic therapies (e.g. cell therapy or growth factors) if currently incarcerated known pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wound Edge Debridement Group<br>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<br>* 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.<br>Other: Standard of Care Treatment<br>* Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.<br>|
| Active Comparator: Standard care group<br>Participants in this group will receive only the standard care of treatment for up to 4 weeks. | Other: Standard of Care Treatment<br>* Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent rate of healing | Percent rate of healing is measured at every weekly visit and divided by 4 to calculate the average percent wound healing rate in cm2/week. | Up to 4 weeks |