Diabetic Foot UlcerOdinnNCT04257370
Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot Amputations
A study testing Kerecis™ Omega3 Wound in people with Diabetic Foot Ulcer and Dehiscence of Amputation Stump, run by Kerecis Ltd. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Dehiscence of Amputation Stump, Amputation
- What is being tested?
- Kerecis™ Omega3 Wound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2020to 25 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 willing to comply with all the clinical trial requirements.
Who cannot join
- Patient whose wound surface is not measurable.
- Patients suffering from unmanaged osteomyelitis. With adequate treatment the patient can be re-screened for the study.
- Patient with severe ischemia (Ankle Brachial Index (ABI) <0.6).
- Patient with necrotic wound who will not tolerate aggressive debridement.
- Patient with immune deficiency or autoimmune disease.
- Patients having done arterial reconstruction within one month. These patients can be re-screened later.
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- Patient on systemic corticosteroids or other treatments causing delayed wound healing.
- Female participants who are pregnant, breast feeding or planning pregnancy during the course of the clinical trial.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the clinical trial, or may influence the result of the clinical trial, or the participant's ability to participate in the clinical trial.
- Patient with known allergy to fish.
- Patient deprived of liberty by judicial or administrative decision, person subject to a legal protection measure.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Sud Francilien
Évry, Corbeil-Essonnes Cedex, 91106
About this study
Official title: An Open Label, Randomized Controlled Study to Compare Healing of Severe Diabetic Foot Ulcers and Forefoot Amputations in Diabetics With and Without Moderate Peripheral Arterial Disease Treated With Kerecis Omega3 Wound and SOC vs. SOC Alone
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.
Read the detailed description
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.
- Being tested
- Kerecis™ Omega3 Wound, Standard of care
- Keywords
- Diabetic foot ulcer, DFU, Dehisced amputation, Acute amputation, Fish skin, Kerecis
- Medical subject headings
- Diabetic Foot, Ichthyosis Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kerecis™ Omega3 WoundDevice
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Kerecis™ Omega3 Wound | Experimental | Not described Receives: Device: Kerecis™ Omega3 Wound |
| Standard of care | Active comparator | Not described Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing at Week 16
Percentage of patients with complete wound epithelialisation at 16 weeks as assessed from photographs by a blinded assessor
Measured: 16 weeks
Secondary outcomes (8)
Ulcer grade
Change in grade of ulcer according to the University of Texas diabetic wound classification at each weekly visit
Measured: 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").
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start9 Jul 2020
- Primary completion30 Sep 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised to receive either Kerecis™ Omega3 Wound plus standard of care, or standard or care alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerecis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète, Allderma Pharmaceuticals, Endospin
- Responsible party
- Sponsor
- Investigators
- Dured Dardari, MD, PhD, Principal investigator, CHSF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257370
- Sponsor's protocol ID
- KS-0370
- Acronym
- Odinn
- Status last verified
- Feb 2023
- First submitted
- 4 Feb 2020
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Margolis DJ, Allen-Taylor L, Hoffstad O, Berlin JA. Diabetic neuropathic foot ulcers: predicting which ones will not heal. Am J Med. 2003 Dec 1;115(8):627-31. doi: 10.1016/j.amjmed.2003.06.006.
PubMed 14656615Barshes NR, Sigireddi M, Wrobel JS, Mahankali A, Robbins JM, Kougias P, Armstrong DG. The system of care for the diabetic foot: objectives, outcomes, and opportunities. Diabet Foot Ankle. 2013 Oct 10;4. doi: 10.3402/dfa.v4i0.21847.
PubMed 24130936Dardari D, Piaggesi A, Potier L, Sultan A, Diener H, Francois M, Dorweiler B, Bouillet B, M'Bemba J, Chaillous L, Clerici G, Kessler L, Wetzel-Roth W, Storck M, Davidsson OB, Baldursson B, Kjartansson H, Lantis JC, Charpentier G. Intact Fish Skin Graft to Treat Deep Diabetic Foot Ulcers. NEJM Evid. 2024 Dec;3(12):EVIDoa2400171. doi: 10.1056/EVIDoa2400171. Epub 2024 Oct 4.
PubMed 39365895
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized Controlled Study to Compare Healing of Severe Diabetic Foot Ulcers and Forefoot Amputations in Diabetics With and Without Moderate Peripheral Arterial Disease Treated With Kerecis Omega3 Wound and SOC vs. SOC Alone
- ClinicalTrials.gov ID
- NCT04257370
- Acronym / sponsor ID
- Odinn / KS-0370
- Keywords
- Diabetic foot ulcer, DFU, Dehisced amputation, Acute amputation, Fish skin, Kerecis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Kerecis Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète, Allderma Pharmaceuticals, Endospin
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomised to receive either Kerecis™ Omega3 Wound plus standard of care, or standard or care alone.
| Arm | Type | Receives |
|---|---|---|
| Kerecis™ Omega3 Wound | Experimental | Device: Kerecis™ Omega3 Wound |
| Standard of care | Active comparator | Other: Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- Patient whose wound surface is not measurable.
- Patients suffering from unmanaged osteomyelitis. With adequate treatment the patient can be re-screened for the study.
- Patient with severe ischemia (Ankle Brachial Index (ABI) <0.6).
- Patient with necrotic wound who will not tolerate aggressive debridement.
- Patient with immune deficiency or autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kerecis™ Omega3 WoundKerecis™ 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. | Device | Kerecis™ Omega3 Wound |
| Standard of careStandard 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. | Other | Standard of care |
Primary outcome
Wound healing at Week 16
Time frame: 16 weeks
Percentage of patients with complete wound epithelialisation at 16 weeks as assessed from photographs by a blinded assessor
8 secondary outcomes
Ulcer grade
Time frame: 16 weeks
Change in quality of life
Time frame: 16 weeks
Change in pain
Time frame: 16 weeks
Healing trajectory
Time frame: 16 weeks
Cost effectiveness
Time frame: 16 weeks
Number of participants with fully healed ulcers at 20 weeks
Time frame: 20 weeks
Number of participants with fully healed ulcers at 24 weeks
Time frame: 24 weeks
Percentage of ulcers healed 50% or more at 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Background: PubMed 14656615Margolis DJ, Allen-Taylor L, Hoffstad O, Berlin JA. Diabetic neuropathic foot ulcers: predicting which ones will not heal. Am J Med. 2003 Dec 1;115(8):627-31. doi: 10.1016/j.amjmed.2003.06.006.
- Background: PubMed 24130936Barshes NR, Sigireddi M, Wrobel JS, Mahankali A, Robbins JM, Kougias P, Armstrong DG. The system of care for the diabetic foot: objectives, outcomes, and opportunities. Diabet Foot Ankle. 2013 Oct 10;4. doi: 10.3402/dfa.v4i0.21847.
- Derived from this study: PubMed 39365895Dardari D, Piaggesi A, Potier L, Sultan A, Diener H, Francois M, Dorweiler B, Bouillet B, M'Bemba J, Chaillous L, Clerici G, Kessler L, Wetzel-Roth W, Storck M, Davidsson OB, Baldursson B, Kjartansson H, Lantis JC, Charpentier G. Intact Fish Skin Graft to Treat Deep Diabetic Foot Ulcers. NEJM Evid. 2024 Dec;3(12):EVIDoa2400171. doi: 10.1056/EVIDoa2400171. Epub 2024 Oct 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dured Dardari, MD, PhD principal investigator
CHSF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kerecis™ Omega3 Wound in people with Diabetic Foot Ulcer and Dehiscence of Amputation Stump, run by Kerecis Ltd. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing at Week 16 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04257370, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.