RecruitingPHASE3INTERVENTIONAL

A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)

This research study is looking into a new gel treatment called EscharEx for people with venous leg ulcers. These are open sores on the legs that happen when blood doesn't flow back to the heart properly. The study aims to see how well EscharEx helps to clean these wounds, preparing them to heal compared to a 'dummy' gel (a placebo) that doesn't contain the active ingredient. We also want to make sure it's safe to use. Around 216 adults with specific types of leg ulcers will take part. Participants won't know if they're receiving the real gel or the dummy gel, and neither will their medical team. This helps us get fair and unbiased results.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

MediWound Ltd

Enrolment target

216

Start

01 Jun 2025

Estimated completion

01 Mar 2027

Venous Leg Ulcer (VLU)

What is this study about?

This study is called VALUE, and it's being done to find out if a new gel called EscharEx can effectively help heal a common type of leg sore called a venous leg ulcer. These ulcers can be difficult to treat and often have a build-up of dead or unhealthy tissue, which needs to be removed for the wound to heal properly. The main goal of this study is to see how good EscharEx is at cleaning these wounds and getting them ready to close up.

Venous leg ulcers happen when the veins in your legs don't work as well as they should, leading to blood pooling and pressure building up. This can damage the skin and cause open sores. Removing the unhealthy tissue is a very important step in treating these ulcers, and we're hoping EscharEx could be a new, helpful way to do this.

We'll be comparing EscharEx to a placebo, which is a gel that looks exactly like EscharEx but doesn't contain any active medicine. This helps us understand if any improvements are truly due to the EscharEx gel or other factors. By carefully studying how patients respond, we hope to learn if EscharEx could become a valuable new treatment option for people living with venous leg ulcers.

Key takeaways

This study is testing a new gel, EscharEx, for venous leg ulcers.
It compares EscharEx to a dummy gel to see if it helps clean wounds.
Participation lasts up to 29 weeks with regular visits.
Neither you nor the doctors will know if you get the real or dummy gel.
You must be an adult with a specific type and size of leg ulcer to join.

Who may be eligible?

To join this study, participants must be adults aged 18 or older and have a venous leg ulcer. This means a sore on your leg caused by poor blood circulation, confirmed by your doctor, and it must have been present for at least 4 weeks but no longer than 1 year.

The ulcer also needs to have a certain amount of unhealthy tissue that needs clearing away – at least half of the wound area. The size of the ulcer should be between 2 and 25 square centimetres. You'll also need to understand what the study involves and be able to follow the study rules. You must give your written permission to take part.

There are also reasons why you might not be able to join. For example, if your wound has already started to shrink significantly, or if you have more than one large ulcer on the same leg. People with signs of infection in or around the wound, very damaged skin nearby, or certain other medical conditions like gangrene or suspected skin cancer around the wound cannot take part. If you have chronic skin problems that might get worse with wound treatment, or if the wound has deep tunnels, you would also be excluded.

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.

Are you 18 years old or older?
Do you have a leg ulcer confirmed by a doctor to be a venous leg ulcer?
Has your ulcer been there for at least 4 weeks but no longer than 1 year?
Is a good portion of your ulcer covered in unhealthy tissue?
Is your ulcer between 2 and 25 square centimetres in size?
Do you not have signs of infection, gangrene, or suspected skin cancer around your wound?

Answer every question to see your result.

What does participation involve?

If you join the study, your total involvement could last up to 29 weeks, which is about seven months. First, there will be two screening visits, about a week apart, to make sure you meet all the requirements.

Then, for up to two weeks, you would have daily visits where the study gel (either EscharEx or the dummy gel) would be applied to your wound. After this, you would have weekly visits for up to 12 weeks for continued wound care and management. There might also be a check-up up to two weeks later to confirm your wound has closed.

Finally, for 12 weeks after your wound has closed, you'll have three monthly visits to check that the healing is lasting. It's important to know that throughout the study, you won't know if you're receiving the active gel or the dummy gel, and neither will the medical staff, so that we can assess the results fairly.

Potential risks and benefits

Participating in this study might offer the potential benefit of trying a new treatment that could help improve the healing of your venous leg ulcer. However, there's no guarantee the treatment will work for everyone, and you might receive the dummy gel. As with any medical treatment, there could be potential risks, such as side effects from the gel or discomfort during wound care. All procedures will be explained to you, and your safety will be closely monitored throughout the study. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (25)

Limb Preservation Platform, Inc
Verified postcode
Fresno, United States· Not yet recruiting
Angel City Research,Inc
Verified postcode
Los Angeles, United States· Recruiting
Center for Clinical Research INC
Verified postcode
San Francisco, United States· Recruiting
ILD Research Center
Verified postcode
Vista, United States· Not yet recruiting
University of Miami
Verified postcode
Miami, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
Boston Medical Center
Verified postcode
Boston, United States· Not yet recruiting
Rutgers New Jersey Medical Center
Verified postcode
Newark, United States· Recruiting
Northwell Health Comprehensive Wound Healing Center
Verified postcode
Lake Success, United States· Active not recruiting
NYU Langone Health Long Island - Research & Academic Center
Verified postcode
Mineola, United States· Recruiting
Mount Sinai West
Verified postcode
New York, United States· Recruiting
Cutting Edge Research LLC.,
Verified postcode
Circleville, United States· Recruiting

Common questions

What is a 'venous leg ulcer'?

It's an open sore on your lower leg caused by poor blood circulation, where blood doesn't flow back to your heart properly.

What is EscharEx?

EscharEx is a new gel treatment being tested to see if it helps clean and heal venous leg ulcers by removing unhealthy tissue.

What does 'double-blind' mean?

It means neither you nor your medical team will know if you're getting the active EscharEx gel or a dummy gel (placebo). This helps make the study results fair.

How long will the study take for me?

Your involvement could last up to about 29 weeks, which includes screening, daily treatments, weekly check-ups, and monthly follow-ups after the wound closes.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without having to give a reason, and it won't affect your regular medical care.

How to find out more

Yael Katz-levy, Ph.D.

yaelk@mediwound.com +972-546774149 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.