DiabetesKereFishNCT04537520
Interventional Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Diabetic Foot Wounds
A study testing Kerecis Omega3 Wound in people with Diabetes and Diabetic Foot Ulcer, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetic Foot Ulcer
- What is being tested?
- Kerecis Omega3 Wound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 12 sitesFrance
- Study dates
- 2 Jul 2020to 16 Dec 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 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
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- 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
Who cannot join
- 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 corticosteroids or other treatments that may delay wound healing
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- Pregnant, breast-feeding or planning pregnancy during the clinical trial
- Any other significant disease or disorder that the investigator believes may pose a risk to participants because of their participation in the clinical trial or that may influence the outcome of the clinical trial or the participant's ability to participate in the clinical trial.
- Patients with rheumatoid arthritis
- Patients with systemic lupus
- Patients with a known skin allergy to fish
- Patients deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CHU de Caen
Caen, 14033
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100
CHU de Dijon - Bocage Sud
Dijon, 21000
Hotel Dieu Le Creusot
Le Creusot, 71200
CHU de Montpellier
Montpellier, 34295
Hôpital Cochin
Paris, 75014
Hopital Bichat-Claude Bernard
Paris, 75018
CHU de Reims - Hôpital Debré
Reims, 51100
Hôpital de Roubaix - CETRADIM
Roubaix, 59100
CHU de Nantes Hôpital Nord Laennec
Saint-Herblain, 44093
CHRU de Strasbourg - Hopital Civil
Strasbourg, 67091
CHU de Toulouse Hôpital Rangueil
Toulouse, 31059
About this study
Official title: Interventional Multi-Center Post Market Randomized Controlled Open-Label Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Hard to Heal Diabetic Foot Wounds
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.
- Conditions
- Diabetes, Diabetic Foot Ulcer
- Being tested
- Kerecis Omega3 Wound
- Keywords
- Complex diabetic foot wounds, Kerecis Omega3Wound, extracellular matrix
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kerecis Omega3 WoundDevice
Treatment of the wound with Kerecis Omega3 Wounds matrices
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | treatment with the device Kerecis Omega3 Wound Receives: Device: Kerecis Omega3 Wound |
| Control Group | No intervention | treatment with SOC treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound area
measuring the surface of the wound with planimetry software
Measured: Week 0
Wound area
measuring the surface of the wound with planimetry software
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start2 Jul 2020
- Primary completion9 Jul 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Collaborators
- Kerecis Ltd., RCTs, Clininfo S.A.
- Responsible party
- Sponsor
- Investigators
- Dured DARDARI, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537520
- Sponsor's protocol ID
- 2018-A01743-52
- Acronym
- KereFish
- Status last verified
- Feb 2023
- First submitted
- 25 Aug 2020
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dardari D, Potier L, Sultan A, Francois M, M'Bemba J, Bouillet B, Chaillous L, Kessler L, Carlier A, Jalek A, Sbaa A, Orlando L, Bobony E, Detournay B, Kjartansson H, Bjorg Arsaelsdottir R, Baldursson BT, Charpentier G. Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study): An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale. Medicina (Kaunas). 2022 Dec 1;58(12):1775. doi: 10.3390/medicina58121775.
PubMed 36556977
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Multi-Center Post Market Randomized Controlled Open-Label Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Hard to Heal Diabetic Foot Wounds
- ClinicalTrials.gov ID
- NCT04537520
- Acronym / sponsor ID
- KereFish / 2018-A01743-52
- Conditions
- Diabetes, Diabetic Foot Ulcer
- Keywords
- Complex diabetic foot wounds, Kerecis Omega3Wound, extracellular matrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Collaborators
- Kerecis Ltd., RCTs, Clininfo S.A.
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 9 Jul 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 3 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Kerecis Omega3 Woundtreatment with the device Kerecis Omega3 Wound |
| Control Group | No intervention | –treatment with SOC treatment |
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 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.
Key exclusion criteria (12 listed)
- 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
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 WoundTreatment of the wound with Kerecis Omega3 Wounds matrices | Device | Experimental Group |
Primary outcome
Wound area
Time frame: Week 0
measuring the surface of the wound with planimetry software
Wound area
Time frame: Week 16
measuring the surface of the wound with planimetry software
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 10 Feb 2023.
- Derived from this study: PubMed 36556977Dardari D, Potier L, Sultan A, Francois M, M'Bemba J, Bouillet B, Chaillous L, Kessler L, Carlier A, Jalek A, Sbaa A, Orlando L, Bobony E, Detournay B, Kjartansson H, Bjorg Arsaelsdottir R, Baldursson BT, Charpentier G. Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study): An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale. Medicina (Kaunas). 2022 Dec 1;58(12):1775. doi: 10.3390/medicina58121775.
- 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 principal investigator
Centre Hospitalier Sud Francilien
12 sites 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 Diabetes and Diabetic Foot Ulcer, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 12 sites 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 12 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 10 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 12 sites 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 area (time frame: Week 0). The study lists 2 primary outcomes in all. 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 NCT04537520, which also lists 1 linked publication.
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 10 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.