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

NCT04537520 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-02-10

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Kerecis Omega3 Wound

Treatment of the wound with Kerecis Omega3 Wounds matrices

Sponsors & Collaborators

  • Kerecis Ltd.

    collaborator INDUSTRY

  • RCTs

    collaborator INDUSTRY

  • Clininfo S.A.

    collaborator INDUSTRY

  • Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

    lead OTHER

Principal Investigators

  • Dured DARDARI, MD · Centre Hospitalier Sud Francilien

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-02
Primary Completion
2022-07-09
Completion
2022-12-16

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04537520 on ClinicalTrials.gov