ClinicalTrials.gg
Sign In
Status unknownNCT05890703LIDOTETRAUpdated Jun 6, 2023

Painless Sharp Wound Debridement With Lidocaine-23%-Tetra-caine-7% Gel Versus EMLA 5% Cream

A Phase 2 interventional study of IMP2 (lidocaine-23%-tetracaine-7% gel) and IMP1 (EMLA 5% cream) in Ulcus Cruris, Ecthyma and Ulcer, Leg, sponsored by Juerg Hafner. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-06-06.

Sponsored by Juerg Hafner · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

In a single-blind, crossover, randomized, controlled trial with 40 participants we aim to demonstrate superior anaesthetic efficacy of lidocaine-23%-tetracaine-7% (IMP2) gel over EMLA 5% cream (IMP1) at comparable safety in sharp wound debridement of chronic leg ulcers.

This is a monocentric investigator initiated trial conducted in the University Hospital Zurich.

In this longitudinal trial, participants receive a sequence of different treatments (treatments on different days) and therefore are randomly assigned to one of two treatment sequences. One-half of participants will first receive IMP1 (first treatment visit, randomized) and then IMP2 (second treatment visit, crossover); the other half of participants the reverse sequence (first treatment visit: IMP2, second treatment visit: IMP1).

Primary Objective: We want to show that IMP 2 (lidocaine-23%-tetracaine-7% gel) is more effective in pain reduction than IMP 1 (EMLA® 5% cream) in sharp wound debridement.

02

Conditions studied

  • Ulcus Cruris
  • Ecthyma
  • Ulcer, Leg
  • Ulcer Venous

Keywords

  • EMLA
  • Lidocain
  • Tetracain
  • Leg ulcer
  • Sharp Wound Debridement
  • Anesthesia
03

In context

Foot Ulcer

692 studies on the registry are indexed under Foot Ulcer; 96 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 563 interventional studies indexed under Foot Ulcer.

Browse Foot Ulcer studies →

Lead sponsor

Juerg Hafner is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    IMP2 (lidocaine-23%-tetracaine-7% gel)

    Drug: IMP2 (lidocaine-23%-tetracaine-7% gel)

  • Active comparator
    IMP1 (EMLA 5% cream)

    Drug: IMP1 (EMLA 5% cream)

Interventions

  • DrugIMP2 (lidocaine-23%-tetracaine-7% gel)

    Applied in a 2 mm thick even layer for 30 minutes on the ulcer with an occlusive dressing. During the second treatment the same dose is applied. Immediately after removal of the occlusive dressing, the rest of the preparation will be removed and sharp debridement will be performed. In order to minimise bias in this crossover trial, the localisation of start (most distal part of Wound) of sharp debridement and the sequence of sharp debridement (if more than one wound; from the largest to the smallest) is defined in the first visit.

  • DrugIMP1 (EMLA 5% cream)

    Applied in a 2 mm thick even layer for 30 minutes on the ulcer with an occlusive dressing. During the second treatment the same dose is applied. Immediately after removal of the occlusive dressing, the rest of the preparation will be removed and sharp debridement will be performed. In order to minimise bias in this crossover trial, the localisation of start (most distal part of Wound) of sharp debridement and the sequence of sharp debridement (if more than one wound; from the largest to the smallest) is defined in the first visit.

06

What researchers measure

Primary outcomes

  1. Local anaesthetic efficacy

    Local anaesthetic efficacy during sharp wound debridement will be assessed with Visual Analogue Scale for pain 15 seconds after start of sharp debridement or earlier in case debridement is completed in less than 15 seconds or early terminated due to intolerable pain.

    Time frame: 15 seconds after start of sharp debridement, pain will be assessed with Visual Analogue Scale

07

Study locations

1 of 1 sites recruiting
  • Department of Dermatology, University Hospital of Zurich, Switzerland
    Zurich, CH-8091, Switzerland
    • Juerg Hafner, M.D. Prof. · Contact · juerg.hafner@usz.ch · +41 44 255 25 33
    • Juerg Hafner, M.D. Prof. · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2023; primary completion for Oct 2023, 4 months later.

Of 20 phase 2 interventional studies under Foot Ulcer, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 49. This study's planned 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 17, 2023
First posted
Jun 6, 2023
StartEst.
Jun 1, 2023
Primary completionEst.
Oct 31, 2023
CompletionEst.
Dec 31, 2023
Last update
Jun 6, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05890703
Lead sponsor
Juerg Hafner
Responsible party
Juerg Hafner (University Hospital Zurich, University of Zurich) — Sponsor-investigator
First posted
Jun 6, 2023
Start date
Jun 1, 2023 (estimated)
Primary completion
Oct 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Jun 6, 2023

Study contacts

Juerg Hafner, Prof.
Contact
juerg.hafner@usz.ch
+41 44 255 25 33

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Lidocaine

Other studies in this condition

Foot Ulcer →

Other studies from this sponsor

Juerg Hafner

Start the discussion