Efficacy of Kerecis Omega 3 in Comparison to Clinical Standard Procedures

Sponsor

Insel Gruppe AG, University Hospital Bern (Other)

Overall Status

Withdrawn

CT.gov ID

NCT06036485

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leg Ulcer	Device: Kerecis Omega 3 Procedure: Surgical debridement	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 in-wound split design with random allocation1:1 in-wound split design with random allocation

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 1, 2023

Actual Primary Completion Date :

May 1, 2023

Actual Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kerecis Omega 3	Device: Kerecis Omega 3 Decellularized intact fish skin developed for the management of chronic wounds
Active Comparator: Surgical debridement	Procedure: Surgical debridement Superficial sharp surgical debridement technique

Arm

Intervention/Treatment

Experimental: Kerecis Omega 3

Device: Kerecis Omega 3

Decellularized intact fish skin developed for the management of chronic wounds

Active Comparator: Surgical debridement

Procedure: Surgical debridement

Superficial sharp surgical debridement technique

Outcome Measures

Primary Outcome Measures

Change in ulcer surface area [12 weeks]
Change in ulcer surface area as assessed by standardized photography and digital imaging.

Secondary Outcome Measures

Change in patient quality of life [2, 4, 6 and 12 weeks]
Change in patient quality of life as assessed by the Wound-QoL questionnaire score, ranging from 0 to 4, with higher scores indicating a worse quality of life.
Change in wound microbiota as assessed by alpha diversity of the microbial composition [2, 4, 6 and 12 weeks]
Change in wound microbiota utilizing 16S-sequencing from wound swabs as assessed by alpha diversity of the microbial composition trough Shannon index, with higher scores indicating a more diversity of the species
Change in wound microbiota as assessed by beta diversity of the microbial composition [2, 4, 6 and 12 weeks]
Change in wound microbiota utilizing 16S-sequencing from wound swabs as assessed by beta diversity of the microbial composition trough Shannon index, with higher scores indicating a more diversity of the species.
Change in ulcer surface area [2, 4, 6 and 12 weeks]
Change in ulcer surface area as assessed by standardized photography and digital imaging.

Other Outcome Measures

Incidence of adverse events [12 weeks]
Cumulative incidence of treatment-related adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Insel Gruppe AG, University Hospital Bern

Investigators

Principal Investigator: Simon Bossart, MD, Department of dermatology, University Hospital Inselspital, Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Insel Gruppe AG, University Hospital Bern

ClinicalTrials.gov Identifier:

NCT06036485

Other Study ID Numbers:

Kerecis-1

First Posted:

Sep 14, 2023

Last Update Posted:

Sep 14, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leg Ulcer

Study Results

No Results Posted as of Sep 14, 2023