Study of EscharEx for Venous Leg Ulcers
This study is looking into a new treatment called EscharEx (EX-03) for venous leg ulcers (VLUs). VLUs are sores on the legs caused by problems with blood flow. EscharEx is a gel made from a powder containing special enzymes (like bromelain) that help clean wounds. We want to see if EscharEx is better and safer than a placebo gel (which looks the same but has no active ingredients) at cleaning these ulcers and helping them heal. You might be able to join if you are an adult over 18 with a VLU that has been present for at least 4 weeks but no longer than a year. The study will measure how well the wounds are cleaned and how quickly they close. The current status of this study is unclear.
- Study design
- This is a double-blind study, meaning neither you nor your doctor will know if you are receiving EscharEx or the placebo. About 216 adult participants with venous leg ulcers will be randomly assigned to one of the treatment groups.
- What's involved
- You would have daily visits for up to 2 weeks for treatment, followed by weekly visits for wound management for up to 12 weeks. There will also be monthly visits for 12 weeks after your wound closes, for a total study duration of up to 29 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 12 weeks to assess wound closure and for an additional 12 weeks after wound closure to check for durability.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
At a glance
Conditions
Where it's being run
62 sites across 39 statesWho to contact
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What this trial measures
- Incidence of complete debridement, clinically (visually) assessed after each applicationup to 2 weeks
counting events of complete debridement
- Facilitation of wound closure, clinically assessed, as measured by time to complete wound closureup to 12 weeks
counting events of complete wound closure until completion of weekly visits