Status:
ACTIVE_NOT_RECRUITING
Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- \>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
- 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
Key Trial Info
Start Date :
March 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT03796793
Start Date
March 18 2019
End Date
December 31 2025
Last Update
May 1 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136