Study Stopped
Lack of funding to support the study
Efficacy of Kerecis Omega 3 in Comparison to Clinical Standard Procedures
Efficacy of Kerecis Omega 3 Versus Standard of Care in Patients With Chronic Leg Ulcerations - a Randomized Trial With a New In-wound Split Design Approach
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
Chronic leg ulcerations are a great burden for patients and the medical system alike. Frequent outpatient consultations with associated treatment costs and travel costs for the patient as well as psychosocial burdens remain an unmet problem in chronic wound care. There is an increasing need for definitive treatment of especially chronic venous and multifactorial chronic leg ulceration where arterial intervention is not a treatment option. Minimal invasive surgical interventions that do not require skin grafting can be performed under local anesthesia in an outpatient setting even in multimorbid patients. Kerecis Omega3 Wound is intact decellularized fish skin. The fish skin sheets contain fat, protein, elastin, glycans and other natural skin elements and it can be an effective treatment option in chronic leg ulcerations and is licensed for this use as a medical product in Switzerland. However, limited data without inter-wound bias is available for the use of Kerecis Omega 3 in chronic leg ulcerations. In this study the investigators propose to investigate the efficacy of Kerecis Omega 3 according to objective wound surface measurements using standardized digital photographs in patients with chronic leg ulcerations. Efficacy will be evaluated against standard of care wound debridement.
Trial Health
Trial Health Score
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Started May 2023
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedFirst Posted
Study publicly available on registry
September 14, 2023
CompletedDecember 6, 2024
December 1, 2024
Same day
March 15, 2023
December 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in ulcer surface area
Change in ulcer surface area as assessed by standardized photography and digital imaging.
12 weeks
Secondary Outcomes (4)
Change in patient quality of life
2, 4, 6 and 12 weeks
Change in wound microbiota as assessed by alpha diversity of the microbial composition
2, 4, 6 and 12 weeks
Change in wound microbiota as assessed by beta diversity of the microbial composition
2, 4, 6 and 12 weeks
Change in ulcer surface area
2, 4, 6 and 12 weeks
Other Outcomes (1)
Incidence of adverse events
12 weeks
Study Arms (2)
Kerecis Omega 3
EXPERIMENTALSurgical debridement
ACTIVE COMPARATORInterventions
Decellularized intact fish skin developed for the management of chronic wounds
Eligibility Criteria
You may qualify if:
- Any chronic leg ulcer \> 4 weeks duration with delayed wound healing (reduction of wound surface of less than 40-50% within 4 weeks under adequate local therapy) without underlying treatable medical conditions
- Ulcer area at between 5cm2 and 60cm2
- Bacterial swab sampling prior to study
- Written study informed consent
You may not qualify if:
- History of Fish allergy or proven Fish allergy
- Pregnant or breast-feeding women
- Intention to become pregnant during the course of the study
- Wound not suitable for dressing: inflammation, fibrin coatings
- Inability to understand the study consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Bossart, MD
Department of dermatology, University Hospital Inselspital, Bern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2023
First Posted
September 14, 2023
Study Start
May 1, 2023
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
December 6, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share