An interventional study of Kerecis™ Omega3 Wound and Standard of care in Diabetic Foot Ulcer, Dehiscence of Amputation Stump and Amputation, sponsored by Kerecis Ltd.. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by Kerecis Ltd. (part of Coloplast A/S) · Not applicable, Interventional, and Treatment
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.
This study is a multi-center study in France, Germany, Italy, and Sweden on the healing effect of Kerecis™ Omega3 Wound in severe diabetic ulcers and open amputation wounds compared to standard of care treatment.
Cell and/or tissue based wound treatment products (CTPs) have been advancing in the treatment of non-healing ulcers in the last 20 years. In 2013, a new product was approved in Europe and by the FDA, intact fish skin, delivered as a sterilized, freeze-dried material, for the treatment of acute and chronic wounds. Fish skin has the benefit of not requiring treatment with antibiotics, or virus inactivating methods, thereby allowing the natural content of the skin to remain, and is a by-product of food industry. Therefore, the fish derived CTP is both ecologically sustainable as well as rich in naturally occurring soluble molecules and omega-3 fatty acids.
A study evaluating the prognosis of diabetic ulcers from large registry data found that the deeper, larger, and more long-standing ulcers would take longer to heal. If a wound was older than 2 months, larger than 2 cm2 and reached bone or tendon, the likelihood of healing in 20 weeks was 19%. The average cost to close a diabetic foot wound with advanced moist wound healing has been calculated at €2300 per cm2, so closing a 3 cm2 wound would cost €6900..
A wealth of clinical experience on diabetic wounds exists on the Kerecis fish skin material. This is, however, mainly in the form of case series and has been published through posters and case reports. The main indication for Kerecis is deep or non-healing diabetic ulcers, which are the biggest problem in diabetic wound care ultimately leading to amputation. Studies on CTPs have almost solely been done on shallow diabetic ulcers to get a homogeneous study population which then is randomized to treatment with the studied product or the control product. This means that in the case of a favourable outcome in the study, those products are not really tested on the ulcer for which they are ultimately intended, ulcers where the next step is amputation.
This randomized controlled study on deep diabetic wounds is designed to prove the efficacy of Kerecis™ Omega3 Wound for the indications it is intended for - severe diabetic foot ulcers - and to show the cost effectiveness of using Kerecis™ Omega3 Wound over standard of care. Wounds resulting from an amputation that are left open with an opening into bone, or from a dehisced amputation where the sutures have gone up, are included. Acute amputations where the metatarsal bones are exposed are included, provided that the patient has diabetes and the amputation is a result of an ulcer.
This study is probably the first study on severe diabetic ulcers where the CTP is used on the types of wounds that it is intended for, thereby giving a straight answer to the actual savings included in healing a serious diabetic wound earlier or changing the stage to a smaller shallower ulcer (changing grade of ulcer), thus, radically changing the prognosis.
1,077 studies on the registry are indexed under Diabetic Foot; 224 are open to participants now.
This study's enrollment of 260 is above the median of 60 across 845 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Kerecis Ltd. is the lead sponsor of 14 studies on the registry; 4 are open to participants now.
First submitted before Kerecis Ltd. became part of Coloplast A/S.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Device: Kerecis™ Omega3 Wound
Other: Standard of care
Kerecis™ Omega3 Wound is decellularised, intact fish skin from North Atlantic cod fish. Kerecis™ Omega3 Wound is FDA approved and EU cleared for the treatment of diabetic ulcers, chronic vascular ulcers, venous ulcers, trauma wounds (including abrasions, lacerations, and skin tears), acute surgical wounds (including debridement, amputation, and donor sites), surgical wounds (dehiscence or failed healing after surgery), imminent failure of STSG, and post-injection necrosis.
Standard of care wound treatment as defined by the local site, including debridement of the wound, standard wound dressing, and proper offloading of the wound site.
Wound healing at Week 16
Percentage of patients with complete wound epithelialisation at 16 weeks as assessed from photographs by a blinded assessor
Time frame: 16 weeks
Ulcer grade
Change in grade of ulcer according to the University of Texas diabetic wound classification at each weekly visit
Time frame: 16 weeks
Change in quality of life
Change in quality of life as assessed by a Wound Quality of Life questionnaire at each weekly visit. The questionnaire contains 17 questions about the patients' wounds and patients will be asked to rate between five values (e.g. Does your wound hurt? Available answers: "not at all", "a little", "moderately", "quite a lot", and "very much").
Time frame: 16 weeks
Change in pain
Pain will be assessed by a visual analogue scale (VAS) at each weekly visit. The VAS will range from 0-10, with 0 being no pain at all, and 10 being worst pain imaginable, and patients will be asked to self-evaluate the pain they experience.
Time frame: 16 weeks
Healing trajectory
Healing trajectories will be plotted via the change in wound surface area in cm2, vs original wound size, calculated at each weekly visit
Time frame: 16 weeks
Cost effectiveness
Better cost-effectiveness than standard of care as calculated by global cost of wound treatment of the two arms and projected costs for non-healed ulcers
Time frame: 16 weeks
Number of participants with fully healed ulcers at 20 weeks
The number of patients with wounds with complete epithelialisation at 20 weeks will be calculated for each arm (checkpoint only)
Time frame: 20 weeks
Number of participants with fully healed ulcers at 24 weeks
The number of patients with wounds with complete epithelialisation at 24 weeks will be calculated for each arm (checkpoint only)
Time frame: 24 weeks
Percentage of ulcers healed 50% or more at 12 weeks
The percentage of ulcers healed 50% or more at 12 weeks will be compared between groups. 50% healing indicates epithelialisation of 50% of the original wound area in cm2.
Time frame: 12 weeks
Plan to share: No
Ran from Jul 2020 to primary completion in Sep 2022, 26 months.
Of 100 industry-sponsored interventional studies with no phase under Diabetic Foot, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 26 months is close to that.
Counting every sponsor, half of 340 studies reached it within 22 months; a quarter within 9 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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