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Procedure
Surgical Debridement for Venous Leg Ulcers
N/A
Recruiting
Led By Marjana Tomic-Canic, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights
Study Summary
This trial will use genomic profiling and candidate genes and proteins to develop a more effective surgical debridement for chronic non-healing venous leg ulcers, with the goal of improving healing.
Who is the study for?
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.Check my eligibility
What is being tested?
The study is testing a new surgical debridement strategy guided by genetic profiling against standard care for healing chronic non-healing venous leg ulcers. The effectiveness of this tailored approach will be evaluated.See study design
What are the potential side effects?
While specific side effects are not listed here, surgical debridement may include risks such as pain at the wound site, infection risk increase due to open wounds and potential bleeding during the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My tests show I have vein problems, or I have at least 2 symptoms like varicose veins or swelling.
Select...
I have a vein-related sore on my leg between my knee and ankle.
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My wound has yellow/white slough or non-viable tissue.
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My wound is larger than 5cm2 and does not show tendon, muscle, or bone.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the genetic profile after debridement in the intervention group.
Secondary outcome measures
Percent rate of healing
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Wound Edge Debridement GroupExperimental Treatment2 Interventions
Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.
Group II: Standard care groupActive Control1 Intervention
Participants in this group will receive only the standard care of treatment for up to 4 weeks.
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
913 Previous Clinical Trials
411,358 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
485 Previous Clinical Trials
1,086,521 Total Patients Enrolled
Marjana Tomic-Canic, PhDPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live less than 6 months.I cannot tolerate weekly compression therapy.I have hepatitis.I have no active cancer except for nonmelanoma skin cancer, and any past cancers have been in remission for 5 years or more.I have kidney disease with a creatinine level over 2.0 in the last 6 months.The ankle brachial index (ABI) is less than 0.80.I am 18 years old or older.My doctor suspects cancer in my venous leg ulcer.My leg ulcers are not caused by vein problems.My tests show I have vein problems, or I have at least 2 symptoms like varicose veins or swelling.I have a vein-related sore on my leg between my knee and ankle.You have had a weak immune system in the past.I haven't used steroids or immunosuppressants in the last 4 weeks.You are allergic to lidocaine or epinephrine.My wound has yellow/white slough or non-viable tissue.My wound is larger than 5cm2 and does not show tendon, muscle, or bone.I have not used biologic therapies for my skin ulcer in the last 4 weeks.I have a recent deep vein clot.I have diabetes with a recent HbA1c level over 12%.I have a bone infection that hasn't been treated.My wound has been present for at least 6 months.You can handle having a bandage wrapped around your limb.My liver tests are more than twice the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: Wound Edge Debridement Group
- Group 2: Standard care group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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