Clinical Study Of Affinity Versus SOC In The Management Of VLUs (NCT04901013) | Clinical Trial Compass
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Clinical Study Of Affinity Versus SOC In The Management Of VLUs
United States200 participantsStarted 2021-06-14
Plain-language summary
This prospective, multi-center, randomized, controlled clinical study compares Affinity® plus SOC to SOC alone in subjects with VLUs. Affinity® will be used along with standard of care on venous leg ulcers (VLUs) of greater than 4 weeks which have not adequately responded to conventional ulcer therapy.
Who can participate
Age range
18 Years – 85 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
. Ulcers of venous origin, as clinically determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and/or dermatitis) or other assessments (e.g. venous reflux test).
. Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy
. Venous insufficiency ulcers between 2 cm2 and 80 cm2
. Partial- or full-thickness VLU, including ulcers with tissue damage that extends through the epidermis and into the upper epidermis (papillary dermis), or into the deep dermis (reticular dermis) but not through muscle, tendon, capsule, or into bone.
. Subjects are between 18 and 85 years of age.
. IRB approved Informed Consent Form is signed before screening and treatment.
. Subject is expected to be available for 24 week follow-up
. Females of child-bearing potential must be practicing an acceptable means of birth control as determined by the investigator.
Exclusion criteria
. Ankle Brachial Index (ABI) of \<0.65
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
Length of time that a wound achieves complete wound closure (CWC)
. Venous insufficiency ulcers less than 2cm2 or greater than 80cm2
. Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases
. Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease
. Signs and symptoms of infection, cellulitis, osteomyelitis
. Necrotic or avascular ulcer beds
. Ulcer with exposed bone, tendon or fascia
. Subjects receiving hemodialysis or have uncontrolled diabetes