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

Diabetes Clinical Trial

— KereFish  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04537520
• Other study ID #: 2018-A01743-52
• Status: Completed
• Phase: N/A
• Start date: July 2, 2020
• Est. completion date: December 16, 2022

Study information

• Verified date: February 2023
• Source: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 16, 2022
• Est. primary completion date: July 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Device:
• Kerecis Omega3 Wound
Treatment of the wound with Kerecis Omega3 Wounds matrices

Locations

Country	Name	City	State
France	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	Hopital Bichat-Claude Bernard	Paris
France	Hôpital Cochin	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

Sponsors (4)

Lead Sponsor	Collaborator
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète	Clininfo S.A., Kerecis Ltd., RCTs

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound area	measuring the surface of the wound with planimetry software	Week 0
Primary	Wound area	measuring the surface of the wound with planimetry software	Week 16