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

February 9, 2023 updated by: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Wound area
Time Frame: Week 0
measuring the surface of the wound with planimetry software
Week 0
Wound area
Time Frame: Week 16
measuring the surface of the wound with planimetry software
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kerecis Ltd.
RCTs
Clininfo S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 9, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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