Clinical trial NCT04537520: Interventional Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Diabetic Foot Wounds
Official title: Interventional Multi-Center Post Market Randomized Controlled Open-Label Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Hard to Heal Diabetic Foot Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Diabetic Foot Ulcer
Keywords: Complex diabetic foot wounds
Kerecis Omega3Wound
extracellular matrix
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
Collaborators: name: Kerecis Ltd.
name: RCTs
name: Clininfo S.A.
First posted: 2020-09-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Wound area
timeFrame: Week 0
measure: Wound area
timeFrame: Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Dijon
country: France
facility: CHU de Dijon - Bocage Sud
city: Le Creusot
country: France
facility: Hotel Dieu Le Creusot
city: Montpellier
country: France
facility: CHU de Montpellier
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hopital Bichat-Claude Bernard
city: Reims
country: France
facility: CHU de Reims - Hôpital Debré
city: Roubaix
country: France
facility: Hôpital de Roubaix - CETRADIM
city: Saint Herblain
country: France
facility: CHU de Nantes Hôpital Nord Laennec
city: Strasbourg
country: France
facility: CHRU de Strasbourg - Hopital Civil
city: Toulouse
country: France
facility: CHU de Toulouse Hôpital Rangueil
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Dured DARDARI, MD
role: PRINCIPAL_INVESTIGATOR
References: