Comparing two pain relief gels for treating chronic leg ulcers
Painless Sharp Wound Debridement With Lidocaine-23%-Tetra-caine-7% Gel Versus EMLA 5% Cream: a Single-blind, Crossover, Randomised, Controlled Trial
This study is testing a new pain relief gel for chronic leg ulcers to see if it works better than a standard cream during painful wound cleaning.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT05890703 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a new gel containing lidocaine and tetracaine compared to EMLA cream in reducing pain during sharp wound debridement of chronic leg ulcers. It is a single-blind, crossover, randomized, controlled trial involving 40 participants who will receive both treatments in a randomized order on different days. The primary goal is to demonstrate that the lidocaine-tetracaine gel provides superior pain relief while maintaining safety during the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with chronic leg ulcers requiring sharp debridement.
Not a fit: Patients who are pregnant, breastfeeding, or have allergies to the study medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management options for patients undergoing treatment for chronic leg ulcers.
How similar studies have performed: Previous studies have shown varying success with similar anesthetic approaches, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants between 18 years and 90 years * Chronic leg ulcer(s) (duration \> 4 weeks) with biofilm or necrotic layers which require 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 study protocol (cognition) * Proficiency in German, oral and written information Exclusion Criteria: * Women who are pregnant or breastfeeding (Women of childbearing potential need to perform a pregnancy test (urine test) within 24 hours prior to the study intervention and need at least one simple acceptable contraceptive method) * Participants with hypersensitivity or allergy to lidocaine, prilocaine, tetracaine or auxiliary supplies contained in either EMLA® 5% cream or lidocaine-23%-tetracaine-7% gel. * Participants with peripheral neuropathy (over 4/10 insensitive points with Semmes monofilament) are excluded due to disturbed pain perception, which could potentially influence the results. * Participants that were previously included in this clinical trial * Participants with a total wound area larger than 200 cm2
Where this trial is running
Zurich
- Department of Dermatology, University Hospital of Zurich, Switzerland — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Juerg Hafner, Prof.
- Email: juerg.hafner@usz.ch
- Phone: +41 44 255 25 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.