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

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

Status

Completed

Conditions

Diabetes

Diabetic Foot Ulcer

Treatments

Device: Kerecis Omega3 Wound

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04537520

2018-A01743-52

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No 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