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Surgical Debridement for Venous Leg Ulcers
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Wound Edge Debridement Group
- Group 2: Standard care group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
How many participants are eligible for this clinical trial?
"Correct. Information on clinicaltrials.gov attests that this medical trial is actively recruiting patients, having been originally posted on March 18th 2019 and edited most recently on May 6th 2022. In total, 360 participants are required from a single research site."
Is enrollment for this trial available to individuals at the present time?
"Affirmative, clinicaltrials.gov highlights that this study is open to participants and has been since March 18th 2019 with the last edit occuring on May 6th 2022. 360 individuals are required for enrolment at one site."
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