Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers (NCT03796793) | Clinical Trial Compass
CompletedNot Applicable
Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers
United States41 participantsStarted 2019-03-18
Plain-language 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 the efficacy of this approach.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. \>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 criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Genetic Profile After Debridement in the Intervention Group.
. 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