Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot Amputations

NACompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

July 9, 2020

Primary Completion Date

September 30, 2022

Study Completion Date

November 25, 2022

Conditions
Diabetic Foot UlcerDehiscence of Amputation StumpAmputation
Interventions
DEVICE

Kerecis™ Omega3 Wound

Kerecis™ Omega3 Wound is decellularised, intact fish skin from North Atlantic cod fish. Kerecis™ Omega3 Wound is FDA approved and EU cleared for the treatment of diabetic ulcers, chronic vascular ulcers, venous ulcers, trauma wounds (including abrasions, lacerations, and skin tears), acute surgical wounds (including debridement, amputation, and donor sites), surgical wounds (dehiscence or failed healing after surgery), imminent failure of STSG, and post-injection necrosis.

OTHER

Standard of care

Standard of care wound treatment as defined by the local site, including debridement of the wound, standard wound dressing, and proper offloading of the wound site.

Trial Locations (1)

91106

Centre Hospitalier Sud Francilien, Évry

Sponsors
All Listed Sponsors
collaborator

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

OTHER

collaborator

Allderma Pharmaceuticals

UNKNOWN

collaborator

Endospin

UNKNOWN

lead

Kerecis Ltd.

INDUSTRY

NCT04257370 - Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot Amputations | Biotech Hunter | Biotech Hunter