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

NCT04257370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2023-02-06

No results posted yet for this study

Summary

This is a prospective, multi-national, multi-centre, randomized, non-blinded (photo evaluation is blinded), controlled clinical investigation in patients suffering from diabetic wounds reaching to tendon, bone, or joint. Patients will be randomised to received intact fish skin (Kerecis™ Omega3 Wound) plus standard of care or standard of care alone, and wound healing compared over 16 weeks.

Conditions

  • Diabetic Foot Ulcer
  • Dehiscence of Amputation Stump
  • Amputation

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.

Sponsors & Collaborators

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

    collaborator OTHER

  • Allderma Pharmaceuticals

    collaborator UNKNOWN

  • Endospin

    collaborator UNKNOWN

  • Kerecis Ltd.

    lead INDUSTRY

Principal Investigators

  • Dured Dardari, MD, PhD · CHSF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2022-09-30
Completion
2022-11-25

Countries

  • France

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 NCT04257370 on ClinicalTrials.gov