NCT04537520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable diabetes

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2022

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

August 25, 2020

Last Update Submit

February 9, 2023

Conditions

DiabetesDiabetic Foot Ulcer

Keywords

Complex diabetic foot woundsKerecis Omega3Woundextracellular matrix

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

treatment with the device Kerecis Omega3 Wound

Device: Kerecis Omega3 Wound

Control Group

NO INTERVENTION

treatment with SOC treatment

Interventions

Kerecis Omega3 WoundDEVICE

Treatment of the wound with Kerecis Omega3 Wounds matrices

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU de Caen

Caen, 14033, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

Location

CHU de Dijon - Bocage Sud

Dijon, 21000, France

Location

Hotel Dieu Le Creusot

Le Creusot, 71200, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hopital Bichat-Claude Bernard

Paris, 75018, France

Location

CHU de Reims - Hôpital Debré

Reims, 51100, France

Location

Hôpital de Roubaix - CETRADIM

Roubaix, 59100, France

Location

CHU de Nantes Hôpital Nord Laennec

Saint-Herblain, 44093, France

Location

CHRU de Strasbourg - Hopital Civil

Strasbourg, 67091, France

Location

CHU de Toulouse Hôpital Rangueil

Toulouse, 31059, France

Location

Related Publications (1)

  • 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.

    PMID: 36556977DERIVED

MeSH Terms

Conditions

Diabetes MellitusDiabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetic Neuropathies

Study Officials

  • Dured DARDARI, MD

    Centre Hospitalier Sud Francilien

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 3, 2020

Study Start

July 2, 2020

Primary Completion

July 9, 2022

Study Completion

December 16, 2022

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(12)