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Omega3 Wound Fish Skin Graft in the Treatment of DFUs

NCT04133493 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-07-06

No results posted yet for this study

Summary

The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-approved product that is derived from minimal processing of Atlantic cod fish skin: KerecisTM Omega3 Wound.

In this trial, two groups of UT grade IA/1C diabetic foot ulcers (DFUs), full skin thickness or extending through the subcutaneous or fat layers but not into tendon, muscle, or bone will receive standard of care (SOC) treatment for their condition. Patients will be randomized to SOC treatment and a 510k FDA-approved collagen alginate dressing (Fibracol Plus) or SOC and KerecisTM Omega3 Wound. The primary endpoint is the percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks in which two groups that will be compared are SOC with Fibracol Plus or SOC with KerecisTM Omega3 Wound

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

Sponsors & Collaborators

  • Kerecis Ltd.

    lead INDUSTRY

Principal Investigators

  • Eric J Lullove, DPM · Eric J. Lullove DPM, PA

  • Gunnar Johannsson, PhD · Kerecis Ltd.

  • John Lantis, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2022-12-30
Completion
2023-01-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04133493 on ClinicalTrials.gov