Omega3 Wound Fish Skin Graft in the Treatment of DFUs

NAActive, not recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 31, 2019

Primary Completion Date

December 30, 2022

Study Completion Date

January 30, 2023

Conditions
Diabetic Foot Ulcer
Interventions
DEVICE

Kerecis Omega3 Wound

"The intervention group will receive, in addition, a fish skin graft (KerecisTM Omega3 Wound) secured with Steristrips, sutures or staples, covered with a nonadherent dressing (Adaptic, Systagenix, Yorkshire, UK or equivalent), the product bolstered down to the wound bed with a foam dressing (HydraFoam, DermaRite) and hydrogel as needed to retain adequate moisture balance and padded with stretch gauze and self adherent wrap as needed.~The wound will be dressed by the site investigator 1 day a week."

DEVICE

Fibracol

The Standard of Care Group will receive Fibracol covered with DSD. Change three times per week

Trial Locations (5)

16635

Bert J. Altmanshofer, DPM, Duncansville

30082

Village Podiatry Centers - Smyrna (Allen Raphael, DPM), Smyrna

33073

Eric J. Lullove DPM, PA, Coconut Creek

43113

Brock Liden, DPM, Circleville

46032

Christopher Winters, DPM, Carmel

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Kerecis Ltd.

INDUSTRY

NCT04133493 - Omega3 Wound Fish Skin Graft in the Treatment of DFUs | Biotech Hunter | Biotech Hunter