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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabetic Foot Ulcer
• Intervention / Treatment: Device: Kerecis Omega3 Wound

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • CHU de Caen
  • Corbeil-Essonnes, France, 91100
    • Centre Hospitalier Sud Francilien
  • Dijon, France, 21000
    • CHU de Dijon - Bocage Sud
  • Le Creusot, France, 71200
    • Hotel Dieu Le Creusot
  • Montpellier, France, 34295
    • CHU de Montpellier
  • Paris, France, 75014
    • Hopital Cochin
  • Paris, France, 75018
    • Hopital Bichat-Claude Bernard
  • Reims, France, 51100
    • CHU de Reims - Hôpital Debré
  • Roubaix, France, 59100
    • Hôpital de Roubaix - CETRADIM
  • Saint Herblain, France, 44093
    • CHU de Nantes Hôpital Nord Laennec
  • Strasbourg, France, 67091
    • CHRU de Strasbourg - Hôpital Civil
  • Toulouse, France, 31059
    • CHU de Toulouse Hôpital Rangueil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Group; treatment with the device Kerecis Omega3 Wound	Device: Kerecis Omega3 Wound; Treatment of the wound with Kerecis Omega3 Wounds matrices
NO_INTERVENTION: Control Group; treatment with SOC treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound area	measuring the surface of the wound with planimetry software	Week 0
Wound area	measuring the surface of the wound with planimetry software	Week 16

Collaborators and Investigators

• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Collaborators: Kerecis Ltd.; RCTs; Clininfo S.A.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 2, 2020
• Primary Completion (ACTUAL): July 9, 2022
• Study Completion (ACTUAL): December 16, 2022

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (ACTUAL): September 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: extracellular matrix; Complex diabetic foot wounds; Kerecis Omega3Wound
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: 2018-A01743-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No