Interventional Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Diabetic Foot Wounds (NCT04537520) | Clinical Trial Compass
CompletedNot Applicable
Interventional Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Diabetic Foot Wounds
France180 participantsStarted 2020-07-02
Plain-language summary
The KereFish study is a randomized controlled study to study the efficacy of Kerecis Omega3 Wound on deep diabetic ulcers. This study is probably the first in his field: in this one, the Kerecis Omega3 Wound dies are used on the types of wounds for which they are ultimately intended. This study aims to document the cost benefits of earlier closure of severe diabetic wounds, or the change of the deep and chronic wound into a smaller and shallower ulcer, and to radically alter its prognosis. The study, carried out in France, uses the pre-existing home nursing system with the transmission of photographs to the reference centre. The study was largely designed to ensure transparency of the financial calculations involved.
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 patients, regardless of the age of their diabetes, with a grade UT 2 or 3 lower limb sore; grade 2: wound penetrating to the tendon or capsule. UT grade 3: wound penetrating to the bone or joint OR hospitalized/ambulatory patients for diabetic foot sores or amputations, which have not closed or are dehiscent.
* Patients who can tolerate aggressive surgical debridement
* Patients without severe ischemia IPS - 0.6 or pressure of the big toe - 50mmHg
* Longness of the wound: 30 days (does not apply to amputation wounds; patients may be included when the wound is less than 30 days old) OR if the amputation level is under the ankle
* Patients willing and able to give informed consent to participate in the clinical trial.
* Male or female over the age of 18
* Patients living at a geographical distance compatible with referral nurse visits
* Negative pregnancy test for women of childbearing age who do not use contraception.
* Patients covered by social security
* Patients who are capable (in the investigator's opinion) and willing to comply with all clinical trial requirements
Exclusion Criteria:
* Patients whose wound surface is not measurable
* Patients with unsealed osteomyelitis
* Patients with fever related to a foot infection (it may be reassessed at a later time when the infection is gone)
* Patients with a necrotic wound that will not tolerate aggressive surgical debridement
* Immunosuppressed patients
* Patients with systemic corticosteroid…
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
Wound area
Timeframe: Week 0
2
Wound area
Timeframe: Week 16
Trial details
NCT IDNCT04537520
SponsorCentre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète