Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

Completed · Not applicable

Conditions studied: Venous Leg Ulcer

In brief

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 facts

Study ID

NCT03796793

Run by

University of Miami

People needed

41

Starts

2019-03-18

Expected to finish

2025-03-25

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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