About this Study
Learn more about the VALUE study, a clinical trial for people with venous leg ulcers.
Purpose of the Trial:
Venous leg ulcers are sores that appear on the leg, usually around the ankle, because blood isn’t flowing properly in the veins. In the US, they’re common, affecting 1-3% of adults.
Things like getting older, being overweight, having blood clots in your legs, or past leg injuries can it make more likely to get them. They are very difficult to heal and can cause a lot of pain and embarrassment to those affected.
01
Wound Cleansing
02
Topical Application
03
Wound Dressing
04
Dressing Change & Re-Application
What is EscharEx®?
Developed by Mediwound, a global leader in non-surgical wound healing products, EscharEx® is a next-generation enzyme based treatment used in the debridement of chronic and other hard-to-heal wounds. Debridement is the process of removing stuck on, dead or infected flesh from these wounds.
EscharEx® is a special powder made in a lab. The main ingredient in the powder is a concentrated form of enzymes, similar to those found in pineapple, called bromelain. These enzymes are thought to help with wound healing. The powder also contains other safe ingredients that help keep the medicine stable. Before using the powder, it will be mixed with sterile water and then applied to your skin.
EscharEx® builds on the success of NexoBrid®, using the same active ingredient to achieve similar results. NexoBrid® is already approved by the health authorities in the US, Europe, and other countries. It helps gently and quickly to remove dead tissue from severe burns and thus supports the healing process.
EscharEx has been tested in three smaller studies, and the results show that it is safe and effective at helping to clean and remove dead tissue from different types of chronic or difficult-to-heal wounds, with only a few daily applications.
More about the VALUE Trial:
To confirm how effective and safe EscharEx® is, the treatment will be used in what’s known as a Phase 3 study in a much larger group of people with Venous Leg Ulcers.
You will be asked to visit the study center up to 24 times within about 6 months for regular applications of the study treatment and monitoring to check how well your wound is healing.
If the study is a good fit for you, we’ll randomly assign you to one of two groups. One group will receive the study medicine, and the other will receive a placebo. You have an equal chance of being in either group.
The placebo looks and feels like the real medicine but doesn’t have the active ingredient (bromelain). It contains the same safe ingredients as the EscharEx® powder, but without the active enzymes.
Who may participate?
- Are at least 18 years old
- Are diagnosed with venous leg ulcer
- Have a wound that has been present for at least 4 weeks but no longer than 18 months
- Have a target wound surface area is in the range of 2-25 cm²
Additional Information
- If you decide to participate in the study and later feel that you no longer wish to be part of it, you can leave at any time.
- Study participants may be compensated for their time or travel
- Any information that you provide will be kept strictly confidential, except as required by law.
Why Participate?
By joining this study, you not only contribute to medical research but also benefit from:
- Comprehensive Support: Patients who take part in the VALUE trial will receive regular study-related health check-ups
- Improving patient Care: Your participation may help improve future treatments for many patients
