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Completed

NCT Number: NCT04537520

Interventional Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Diabetic Foot Wounds

The KereFish study is a randomized controlled study to study the efficacy of Kerecis Omega3 Wound on deep diabetic ulcers. This study is probably the first in his field: in this one, the Kerecis Omega3 Wound dies are used on the types of wounds for which they are ultimately intended. This study aims to document the cost benefits of earlier closure of severe diabetic wounds, or the change of the deep and chronic wound into a smaller and shallower ulcer, and to radically alter its prognosis. The study, carried out in France, uses the pre-existing home nursing system with the transmission of photographs to the reference centre. The study was largely designed to ensure transparency of the financial calculations involved.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcer Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Caen, Caen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetic patients, regardless of the age of their diabetes, with a grade UT 2 or 3 lower limb sore; grade 2: wound penetrating to the tendon or capsule. UT grade 3: wound penetrating to the bone or joint OR hospitalized/ambulatory patients for diabetic foot sores or amputations, which have not closed or are dehiscent.
  • Patients who can tolerate aggressive surgical debridement
  • Patients without severe ischemia IPS - 0.6 or pressure of the big toe - 50mmHg
  • Longness of the wound: 30 days (does not apply to amputation wounds; patients may be included when the wound is less than 30 days old) OR if the amputation level is under the ankle
  • Patients willing and able to give informed consent to participate in the clinical trial.
  • Male or female over the age of 18
  • Patients living at a geographical distance compatible with referral nurse visits
  • Negative pregnancy test for women of childbearing age who do not use contraception.
  • Patients covered by social security
  • Patients who are capable (in the investigator's opinion) and willing to comply with all clinical trial requirements

Exclusion criteria

  • Patients whose wound surface is not measurable
  • Patients with unsealed osteomyelitis
  • Patients with fever related to a foot infection (it may be reassessed at a later time when the infection is gone)
  • Patients with a necrotic wound that will not tolerate aggressive surgical debridement
  • Immunosuppressed patients
  • Patients with systemic corticosteroids or other treatments that may delay wound healing
  • Pregnant, breast-feeding or planning pregnancy during the clinical trial
  • Any other significant disease or disorder that the investigator believes may pose a risk to participants because of their participation in the clinical trial or that may influence the outcome of the clinical trial or the participant's ability to participate in the clinical trial.
  • Patients with rheumatoid arthritis
  • Patients with systemic lupus
  • Patients with a known skin allergy to fish
  • Patients deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure

Treatment and study plan

Kerecis Omega3 Wound

Device

Treatment of the wound with Kerecis Omega3 Wounds matrices

Primary outcomes

  1. Wound area

    Time frame: Week 0

    measuring the surface of the wound with planimetry software

  2. Wound area

    Time frame: Week 16

    measuring the surface of the wound with planimetry software

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Clininfo S.A.
  • Kerecis Ltd.
  • RCTs

Registry information

Official study title

Interventional Multi-Center Post Market Randomized Controlled Open-Label Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Hard to Heal Diabetic Foot Wounds

Acronym: KereFish

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 3, 2020
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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