Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot … (NCT04257370) | Clinical Trial Compass
CompletedNot Applicable
Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot Amputations
France260 participantsStarted 2020-07-09
Plain-language summary
This is a prospective, multi-national, multi-centre, randomized, non-blinded (photo evaluation is blinded), controlled clinical investigation in patients suffering from diabetic wounds reaching to tendon, bone, or joint. Patients will be randomised to received intact fish skin (Kerecis™ Omega3 Wound) plus standard of care or standard of care alone, and wound healing compared over 16 weeks.
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:
* Diabetic patient with chronic lower extremity wounds: Grade 2 or 3 according to University of Texas score: Grade 2: "Wounds that penetrate to tendon or capsule". Grade 3: "wounds that penetrate to bone or into the joint". In this context, probing gently to bone means that the wound reaches bone.
* OR patients with diabetes that are recently amputated below the ankle, where the wound has not been closed or has dehisced and bones/tendons are exposed.
* Patients that have moderately decreased or normal arterial circulation. In this study the cutoff point is Ankle Brachial Index (ABP) below 0.6. (Toe pressure and TPCO2 values will be obtained if possible. Toe pressure of 50mmHg and a TCPO2 value of 40mm on the dorsum of the foot is often considered as indicative of adequate perfusion.)
* Patients who will tolerate aggressive debridement. Light bleeding of the wound surface should be seen after debridement.
* Patient has had his/her ulcer for one month.
* Participant is willing and able to give informed consent for participation in the clinical trial.
* Male or Female, over 18 years.
* Geographical distance compatible with taking part in the study. Observe though that the patient can be treated at a "home clinic" every other week as long as the end point is not imminent and photos and acetate tracers with cm markers are fed into the photo portal.
* Negative pregnancy test for a woman of childbearing age.
* Patient is able (in the investigator's opinion) and …
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.