Last updated: June 5, 2023
Sponsor: Juerg Hafner
Overall Status: Active - Recruiting
Phase
2
Condition
Ulcers
Venous Leg Ulcers
Treatment
IMP2 (lidocaine-23%-tetracaine-7% gel)
IMP1 (EMLA 5% cream)
Clinical Study ID
NCT05890703
LIDOTETRA
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants between 18 years and 90 years
- Chronic leg ulcer(s) (duration > 4 weeks) with biofilm or necrotic layers whichrequire consecutive sharp debridement for at least two times (of the same ulcer)
- Minimal ulcer area of 1 cm2
- Leg ulcer has to enter into one of the following well defined aetiologies: venous,mixed venous-arterial, arterial, hypertensive ischemic leg ulcer (Martorell),vasculitic, ecthyma (covering >90% of all observed leg ulcers)
- Informed consent as documented by signature and being able to follow the studyprotocol (cognition)
- Proficiency in German, oral and written information
Exclusion
Exclusion Criteria:
- Women who are pregnant or breastfeeding (Women of childbearing potential need toperform a pregnancy test (urine test) within 24 hours prior to the study interventionand need at least one simple acceptable contraceptive method)
- Participants with hypersensitivity or allergy to lidocaine, prilocaine, tetracaine orauxiliary supplies contained in either EMLA® 5% cream or lidocaine-23%-tetracaine-7%gel.
- Participants with peripheral neuropathy (over 4/10 insensitive points with Semmesmonofilament) are excluded due to disturbed pain perception, which could potentiallyinfluence the results.
- Participants that were previously included in this clinical trial
- Participants with a total wound area larger than 200 cm2
Study Design
Total Participants: 40
Treatment Group(s): 2
Primary Treatment: IMP2 (lidocaine-23%-tetracaine-7% gel)
Phase: 2
Study Start date:
June 01, 2023
Estimated Completion Date:
December 31, 2023
Connect with a study center
Department of Dermatology, University Hospital of Zurich, Switzerland
Zurich, CH-8091
SwitzerlandActive - Recruiting
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