Efficacy of Kerecis Omega 3 in Comparison to Clinical Standard Procedures

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Leg Ulcer

Clinical Trial Details

NCT number	NCT06036485
Study type	Interventional
Source	Insel Gruppe AG, University Hospital Bern
Contact
Status	Withdrawn
Phase	N/A
Start date	May 1, 2023
Completion date	May 1, 2023

View Details

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