A multicenter, prospective, randomized, placebo and non-surgical standard of care (NSSOC) controlled study, performed to evaluate the safety and efficacy of EscharEx and its placebo (gel vehicle) compared to NSSOC in participants with Venous Leg Ulcers (VLU)
Venous leg ulcers are long-lasting sores on the lower leg caused by poor blood flow. For these wounds to heal properly, doctors must clear away dead or damaged tissue from the surface of the skin. This phase 2 clinical trial is testing a new gel called EscharEx to see if it can clean wounds safely and help them heal faster. Participants will be randomly placed into one of three groups to receive either EscharEx, an inactive dummy gel (placebo), or usual non-surgical wound care. The research team will track pain levels, monitor vital signs, take blood tests, and use special digital camera scans to measure wound size over time. The goal is to see whether EscharEx provides a safe, gentle, and effective treatment option for people living with persistent leg ulcers.
At a glance
What is this study about?
Venous leg ulcers are open sores on the lower leg that can take months or even years to heal. They usually happen when blood does not flow back up the leg veins as well as it should, leading to built-up pressure that damages the skin. Over time, dead skin and damaged tissue can collect in the wound. This dead tissue stops healthy new skin from growing and can increase the risk of infection.
In this study, researchers are testing an experimental treatment gel called EscharEx. The gel is designed to gently dissolve and break down dead tissue in the ulcer without the need for surgical cutting or scraping. The trial compares EscharEx against two other approaches: a dummy gel with no active ingredients (a placebo) and standard non-surgical wound care.
Doctors want to find out whether EscharEx is safe, how well it clears away the dead tissue, and whether it helps the ulcer close up more quickly. By closely monitoring healing rates and everyday pain, researchers hope to discover if this gel could provide a better, less uncomfortable treatment option for people with persistent leg ulcers.
Key takeaways
- Tests a new gel (EscharEx) designed to clear dead tissue from venous leg ulcers.
- Compares the active gel against a dummy gel and standard wound care.
- Open to men and women aged 18 and older with a diagnosed venous ulcer.
- Requires daily visits during the early treatment phase, followed by weekly check-ups.
- Monitors wound healing, pain levels, and general safety throughout the study.
Who may be eligible?
This trial is open to adults of any gender who are 18 years of age or older and have an active venous leg ulcer that needs treatment to clear away dead tissue.
To be considered, your ulcer must be confirmed as a venous ulcer by the study medical team, and you must be generally well enough to follow the study timetable. You will also need to be able to attend frequent clinic visits, especially in the first week or two.
You might not be able to take part if you have certain severe infections, other major medical conditions that affect wound healing, or known allergies to any ingredients in the study gel. The trial doctor will review your full medical history with you to ensure taking part is safe.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am 18 years old or older.
- I have an open sore or ulcer on my lower leg.
- My ulcer has been diagnosed as a venous leg ulcer.
- I am able to attend daily clinic appointments for the first week or two.
- I am willing to have regular blood tests and non-touch wound photos taken.
What does participation involve?
Taking part in this study involves several stages. During the initial treatment period, you will need to attend daily clinic appointments (for up to 8 treatments) so the study team can apply the gel or standard wound dressing and check your ulcer. After this daily stage, you will move to weekly clinic visits to monitor your recovery. During appointments, the team will check your vital signs, take routine blood samples, ask you to rate any wound pain, and measure your ulcer using a gentle digital imaging camera. The study continues until your wound closes or for several weeks of planned follow-up.
Potential risks and benefits
Locations (2)
- —UnverifiedCzechia
- —UnverifiedSlovakia
Common questions
What is EscharEx?
EscharEx is an investigational gel made to gently break down and remove dead tissue from chronic wounds to help healthy skin regrow.
Will I definitely receive the new gel?
No. A computer randomly decides whether you receive EscharEx, a dummy gel without active medication, or standard non-surgical wound care.
Is the wound measurement painful?
No. The study team uses a special digital camera scanner to measure the size of your ulcer without needing to touch or press on the wound.
Can I stop taking part if I change my mind?
Yes. You can leave the study at any point without giving a reason, and it will not affect the usual medical care you receive.
What should I do if my leg feels more painful during the trial?
You should tell the study team immediately. They will assess your ulcer, record your pain scores, and adjust your pain relief or care as needed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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