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

NCT04257370 | Completed

• 1 other identifier: KS-0370
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetic foot ulcer; DFU; Dehisced amputation; Acute amputation; Fish skin; Kerecis

Outcome Measures

Primary Outcomes (1)

• Wound healing at Week 16

  Percentage of patients with complete wound epithelialisation at 16 weeks as assessed from photographs by a blinded assessor

  16 weeks

Secondary Outcomes (8)

• Ulcer grade

  16 weeks

• Change in quality of life

  16 weeks

• Change in pain

  16 weeks

• Healing trajectory

  16 weeks

• Cost effectiveness

  16 weeks

Study Arms (2)

Kerecis™ Omega3 Wound

EXPERIMENTAL

Device: Kerecis™ Omega3 Wound

Standard of care

ACTIVE COMPARATOR

Other: Standard of care

Interventions

Kerecis™ Omega3 Wound DEVICE

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.

Kerecis™ Omega3 Wound

Standard of care OTHER

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.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic patient with chronic lower extremity wounds: Grade 2 or 3 according to University of Texas score: Grade 2: "Wounds that penetrate to tendon or capsule". Grade 3: "wounds that penetrate to bone or into the joint". In this context, probing gently to bone means that the wound reaches bone.
• OR patients with diabetes that are recently amputated below the ankle, where the wound has not been closed or has dehisced and bones/tendons are exposed.
• Patients that have moderately decreased or normal arterial circulation. In this study the cutoff point is Ankle Brachial Index (ABP) below 0.6. (Toe pressure and TPCO2 values will be obtained if possible. Toe pressure of 50mmHg and a TCPO2 value of 40mm on the dorsum of the foot is often considered as indicative of adequate perfusion.)
• Patients who will tolerate aggressive debridement. Light bleeding of the wound surface should be seen after debridement.
• Patient has had his/her ulcer for one month.
• Participant is willing and able to give informed consent for participation in the clinical trial.
• Male or Female, over 18 years.
• Geographical distance compatible with taking part in the study. Observe though that the patient can be treated at a "home clinic" every other week as long as the end point is not imminent and photos and acetate tracers with cm markers are fed into the photo portal.
• Negative pregnancy test for a woman of childbearing age.
• Patient is able (in the investigator's opinion) and willing to comply with all the clinical trial requirements.

You may not qualify if:

• Patient whose wound surface is not measurable.
• Patients suffering from unmanaged osteomyelitis. With adequate treatment the patient can be re-screened for the study.
• Patient with severe ischemia (Ankle Brachial Index (ABI) \<0.6).
• Patient with necrotic wound who will not tolerate aggressive debridement.
• Patient with immune deficiency or autoimmune disease.
• Patients having done arterial reconstruction within one month. These patients can be re-screened later.
• Patient on systemic corticosteroids or other treatments causing delayed wound healing.
• Female participants who are pregnant, breast feeding or planning pregnancy during the course of the clinical trial.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the clinical trial, or may influence the result of the clinical trial, or the participant's ability to participate in the clinical trial.
• Patient with known allergy to fish.
• Patient deprived of liberty by judicial or administrative decision, person subject to a legal protection measure.

Sponsors & Collaborators

• Kerecis Ltd.: lead
• Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète: collaborator
• Allderma Pharmaceuticals: collaborator
• Endospin: collaborator

Study Sites (1)

Centre Hospitalier Sud Francilien

Évry, Corbeil-Essonnes Cedex, 91106, France

Location

Related Publications (3)

• Margolis DJ, Allen-Taylor L, Hoffstad O, Berlin JA. Diabetic neuropathic foot ulcers: predicting which ones will not heal. Am J Med. 2003 Dec 1;115(8):627-31. doi: 10.1016/j.amjmed.2003.06.006.

  PMID: 14656615 BACKGROUND

• Barshes NR, Sigireddi M, Wrobel JS, Mahankali A, Robbins JM, Kougias P, Armstrong DG. The system of care for the diabetic foot: objectives, outcomes, and opportunities. Diabet Foot Ankle. 2013 Oct 10;4. doi: 10.3402/dfa.v4i0.21847.

  PMID: 24130936 BACKGROUND

• Dardari D, Piaggesi A, Potier L, Sultan A, Diener H, Francois M, Dorweiler B, Bouillet B, M'Bemba J, Chaillous L, Clerici G, Kessler L, Wetzel-Roth W, Storck M, Davidsson OB, Baldursson B, Kjartansson H, Lantis JC, Charpentier G. Intact Fish Skin Graft to Treat Deep Diabetic Foot Ulcers. NEJM Evid. 2024 Dec;3(12):EVIDoa2400171. doi: 10.1056/EVIDoa2400171. Epub 2024 Oct 4.

  PMID: 39365895 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Ichthyosis Vulgaris

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Keratosis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Dured Dardari, MD, PhD

  CHSF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluation of wound closure at defined time points will be done by an assessor blinded to the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomised to receive either Kerecis™ Omega3 Wound plus standard of care, or standard or care alone.

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: July 9, 2020
• Primary Completion: September 30, 2022
• Study Completion: November 25, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)