Omega3 Wound Fish Skin Graft in the Treatment of DFUs

The study is a prospective, multi-center, parallel-group RCT designed to collect outcome data for the treatment of DFUs. The trial will be single blinded in regard to wound healing assessment (confirmation of wound healing will be overseen by an independent wound care adjudicator). There are two arms in the study, both of which will receive standard of care (SOC): offloading of the DFU (CAM boots (Royce walker with diabetic inlay or equivalent) or total contact casting \[TCC\] if compliance issues or the subject's foot is too large for a CAM), appropriate sharp or surgical debridement. Patients cannot be on systemic antibiotics prior to randomization, infection management during treatment phase can include systemic antibiotics only in conjunction with debridement. Arm 1 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. Arm 2 will receive a wound care covering comprising collagen alginate Fibracol plus dressing followed by a padded dressing comprised of 4x4 gauze pads, stretch gauze and self adherent wrap The wound will be dressed by patients or their caregivers at home 3 times a week and by the site investigator 1 day a week. The study involves two phases: Screening and Treatment