Surgical Debridement for Venous Leg Ulcers
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those who require long-term systemic corticosteroids or immunosuppressive therapy, or have used them in the 4 weeks prior to the study.
Is surgical debridement generally safe for humans?
Surgical debridement is considered safe when the wound is properly prepared, meaning it has good blood flow, the right antibiotics are used, and other health issues are managed. Enzymatic debridement, a related method, is safe even in wounds with high bacteria levels if used with topical antimicrobials.12345
How is the treatment Wound Edge Debridement unique for venous leg ulcers?
Wound Edge Debridement is unique because it involves the physical removal of dead or infected tissue to promote healing, which can be done through various methods like surgical, mechanical, or enzymatic techniques. This treatment is essential for improving blood flow and reducing infection risk, making it different from other treatments that might focus solely on managing symptoms or underlying causes.678910
What data supports the effectiveness of the treatment for venous leg ulcers?
Debridement, which involves removing dead or infected tissue, is essential for wound healing as it improves blood flow, reduces inflammation, and lowers infection risk. Various debridement techniques, including surgical and enzymatic methods, have been shown to aid in the healing of leg ulcers by preparing the wound bed and promoting tissue regeneration.468911
Who Is on the Research Team?
Marjana Tomic-Canic, PhD
Principal Investigator
University of Miami
Robert Kirsner, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
Adults over 18 with chronic venous leg ulcers between the knee and ankle, larger than 5cm2, lasting at least 6 months can join. They must have signs of venous disease but no severe health issues like active cancer, uncontrolled diabetes, recent biologic therapy for ulcers, or allergies to certain anesthetics.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive wound edge debridement in addition to standard of care treatment or only standard care treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Wound Edge Debridement
Wound Edge Debridement is already approved in European Union, United States, Canada for the following indications:
- Venous Leg Ulcers
- Diabetic Foot Ulcers
- Pressure Ulcers
- Chronic Wounds
- Venous Leg Ulcers
- Diabetic Foot Ulcers
- Pressure Ulcers
- Chronic Wounds
- Venous Leg Ulcers
- Diabetic Foot Ulcers
- Pressure Ulcers
- Chronic Wounds
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator