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

Primary Purpose

Diabetes, Diabetic Foot Ulcer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Kerecis Omega3 Wound
Sponsored by
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Complex diabetic foot wounds, Kerecis Omega3Wound, extracellular matrix

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Caen
  • Centre Hospitalier Sud Francilien
  • CHU de Dijon - Bocage Sud
  • Hotel Dieu Le Creusot
  • CHU de Montpellier
  • Hôpital Cochin
  • Hopital Bichat-Claude Bernard
  • CHU de Reims - Hôpital Debré
  • Hôpital de Roubaix - CETRADIM
  • CHU de Nantes Hôpital Nord Laennec
  • CHRU de Strasbourg - Hopital Civil
  • CHU de Toulouse Hôpital Rangueil

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

treatment with the device Kerecis Omega3 Wound

treatment with SOC treatment

Outcomes

Primary Outcome Measures

Wound area
measuring the surface of the wound with planimetry software
Wound area
measuring the surface of the wound with planimetry software

Secondary Outcome Measures

Full Information

First Posted
August 25, 2020
Last Updated
February 9, 2023
Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Collaborators
Kerecis Ltd., RCTs, Clininfo S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04537520
Brief Title
Interventional Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Diabetic Foot Wounds
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
July 9, 2022 (Actual)
Study Completion Date
December 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Collaborators
Kerecis Ltd., RCTs, Clininfo S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetic Foot Ulcer
Keywords
Complex diabetic foot wounds, Kerecis Omega3Wound, extracellular matrix

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
treatment with the device Kerecis Omega3 Wound
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
treatment with SOC treatment
Intervention Type
Device
Intervention Name(s)
Kerecis Omega3 Wound
Intervention Description
Treatment of the wound with Kerecis Omega3 Wounds matrices
Primary Outcome Measure Information:
Title
Wound area
Description
measuring the surface of the wound with planimetry software
Time Frame
Week 0
Title
Wound area
Description
measuring the surface of the wound with planimetry software
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dured DARDARI, MD
Organizational Affiliation
Centre Hospitalier Sud Francilien
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
CHU de Dijon - Bocage Sud
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Hotel Dieu Le Creusot
City
Le Creusot
ZIP/Postal Code
71200
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Bichat-Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
CHU de Reims - Hôpital Debré
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Hôpital de Roubaix - CETRADIM
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
CHU de Nantes Hôpital Nord Laennec
City
Saint Herblain
ZIP/Postal Code
44093
Country
France
Facility Name
CHRU de Strasbourg - Hopital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU de Toulouse Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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