Interventional Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Diabetic Foot Wounds

NCT ID: NCT04537520

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-02
• Study Completion Date: 2022-12-16

Brief 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.

Conditions

Diabetes; Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

treatment with the device Kerecis Omega3 Wound

Group Type: EXPERIMENTAL

Kerecis Omega3 Wound

Intervention Type: DEVICE

Treatment of the wound with Kerecis Omega3 Wounds matrices

Control Group

treatment with SOC treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Kerecis Omega3 Wound

Treatment of the wound with Kerecis Omega3 Wounds matrices

Intervention Type: DEVICE

Eligibility Criteria

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 corticosteroids or other treatments that may delay wound healing
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kerecis Ltd.

INDUSTRY

Sponsor Role: collaborator

RCTs

INDUSTRY

Sponsor Role: collaborator

Clininfo S.A.

INDUSTRY

Sponsor Role: collaborator

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dured DARDARI, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sud Francilien

Locations

CHU de Caen

Caen, , France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

CHU de Dijon - Bocage Sud

Dijon, , France

Hotel Dieu Le Creusot

Le Creusot, , France

CHU de Montpellier

Montpellier, , France

Hôpital Cochin

Paris, , France

Hopital Bichat-Claude Bernard

Paris, , France

CHU de Reims - Hôpital Debré

Reims, , France

Hôpital de Roubaix - CETRADIM

Roubaix, , France

CHU de Nantes Hôpital Nord Laennec

Saint-Herblain, , France

CHRU de Strasbourg - Hopital Civil

Strasbourg, , France

CHU de Toulouse Hôpital Rangueil

Toulouse, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 36556977 (View on PubMed)

Other Identifiers

2018-A01743-52

Identifier Type: -

Identifier Source: org_study_id