Status:
WITHDRAWN
Efficacy of Kerecis Omega 3 in Comparison to Clinical Standard Procedures
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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 psyc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06036485
Start Date
May 1 2023
End Date
May 1 2023
Last Update
December 6 2024
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