Clinical trial NCT06036485: Efficacy of Kerecis Omega 3 in Comparison to Clinical Standard Procedures
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Leg Ulcer
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 in-wound split design with random allocation
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in ulcer surface area
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in patient quality of life
timeFrame: 2, 4, 6 and 12 weeks
measure: Change in wound microbiota as assessed by alpha diversity of the microbial composition
timeFrame: 2, 4, 6 and 12 weeks
measure: Change in wound microbiota as assessed by beta diversity of the microbial composition
timeFrame: 2, 4, 6 and 12 weeks
measure: Change in ulcer surface area
timeFrame: 2, 4, 6 and 12 weeks
Other outcomes:
measure: Incidence of adverse events
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: Department of dermatology, University Hospital Inselspital, Bern
name: Simon Bossart, MD
role: PRINCIPAL_INVESTIGATOR
References: