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

Last updated: February 9, 2023
Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Overall Status: Completed

Phase

N/A

Condition

Diabetic Gastroparesis

Diabetes Mellitus, Type 2

Diabetic Neuropathy

Treatment

N/A

Clinical Study ID

NCT04537520
2018-A01743-52
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diabetic patients, regardless of the age of their diabetes, with a grade UT 2 or 3lower 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 fordiabetic 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 beincluded when the wound is less than 30 days old) OR if the amputation level is underthe ankle
  • Patients willing and able to give informed consent to participate in the clinicaltrial.
  • 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 withall clinical trial requirements

Exclusion

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 timewhen 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 woundhealing
  • Pregnant, breast-feeding or planning pregnancy during the clinical trial
  • Any other significant disease or disorder that the investigator believes may pose arisk to participants because of their participation in the clinical trial or that mayinfluence the outcome of the clinical trial or the participant's ability toparticipate 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 subjectto a legal protection measure

Study Design

Total Participants: 180
Study Start date:
July 02, 2020
Estimated Completion Date:
December 16, 2022

Connect with a study center

  • CHU de Caen

    Caen, 14033
    France

    Site Not Available

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91100
    France

    Site Not Available

  • CHU de Dijon - Bocage Sud

    Dijon, 21000
    France

    Site Not Available

  • Hotel Dieu Le Creusot

    Le Creusot, 71200
    France

    Site Not Available

  • CHU de Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • Hopital Bichat-Claude Bernard

    Paris, 75018
    France

    Site Not Available

  • Hôpital Cochin

    Paris, 75014
    France

    Site Not Available

  • CHU de Reims - Hôpital Debré

    Reims, 51100
    France

    Site Not Available

  • Hôpital de Roubaix - CETRADIM

    Roubaix, 59100
    France

    Site Not Available

  • CHU de Nantes Hôpital Nord Laennec

    Saint Herblain, 44093
    France

    Site Not Available

  • CHRU de Strasbourg - Hopital Civil

    Strasbourg, 67091
    France

    Site Not Available

  • CHU de Toulouse Hôpital Rangueil

    Toulouse, 31059
    France

    Site Not Available

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