About the VALUE Trial
Learn more about the VALUE Trial, a clinical trial for people with venous leg ulcers.
Purpose of the Trial:
The purpose of the VALUE trial is to evaluate a study medicine, known as EscharEx®, to see if it can safely and effectively help to clean wounds by removing damaged skin and help the growth of healthy tissue. These important steps help prepare wounds to be closed—either with a skin graft or other advanced treatments—to speed up healing.
EscharEx has been tested in three earlier studies: 131 patients with hard to heal wounds (mainly Venous Leg Ulcers and Diabetic Foot Ulcers) were treated with EscharEx® and the results indicate that EscharEx® is safe and effective when used to clean and remove damaged tissue from Venous Leg Ulcers and other hard-to-heal wounds, with just a few daily applications. EscharEx® was also found to help the growth of healthy tissue with a rich blood supply – helping wounds heal faster.
The VALUE trial hopes to reproduce these results, this time in a much larger group of people diagnosed with Venous Leg Ulcers.
What is EscharEx®?
EscharEx®, created by MediWound, is a new study medicine aimed at treating hard -to-heal Venous Leg Ulcers. It’s active ingredient, bromelain, is a naturally occurring enzyme (or protein that promotes biological processes) extracted from the pineapple plant.
Bromelain works to gently remove only the damaged tissue from your wound, creating the right conditions for healthy tissue to grow – leading to faster wound healing.
EscharEx® comes in the form of a powder, made under sterile laboratory conditions. Before it’s applied to your wound, the powder will be mixed with sterile water to make a gel – allowing it to be gently applied to your wound by a doctor.
EscharEx® contains the same active ingredient used in a product called NexoBrid®, also manufactured by MediWound, which is already approved in the United States, Europe and other countries for quickly and safely removing dead tissue from severe burns. To date, it has been used to treat around 13,000 burn patients across the world.
01
Wound Cleansing
02
Topical Application
03
Wound Dressing
04
Dressing Change & Re-Application
More about the VALUE Trial:
To confirm how effective and safe EscharEx® is, when used in cases of venous leg ulcers, MediWound is conducting a Phase 3 study. A phase 3 study includes a much larger group of people than in previous trials.
To make sure that you are a good fit to participate in the study, you’ll have to choose your nearest trial site and fill out a pre-screening questionnaire. 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 placebo. You have an equal chance of being in either group.
The placebo looks and feels like the real medicine and contains the same ingredients as the EscharEx® powder, just not the active ingredient, bromelain.
The placebo gel used in the study will help to keep the wound moist, which—together with modern dressings—creates a good environment for healing.
All patients in the trial will also receive compression therapy, which is essential for treating venous leg ulcers. If your wound is ready for advanced treatments like skin grafts or special wound coverings: you will receive them – at no cost.
You will be asked to visit the study center (up to 26 times within about 6 months), firstly for up to 8 topical applications of the study treatment, and later, for standard treatments and monitoring to check how well your wound is healing.
Who may participate?
- Are at least 18 years old
- Have been diagnosed with a venous leg ulcer
- Have a wound that has been open for at least 4 weeks but no longer than 1 year
Additional Information
- All Study participants will be compensated for their time and travel to trial sites, with no need for healthcare or insurance.
- The VALUE Trial follows US FDA regulations to protect all participants.
- If you decide to take part in the study and later feel that you don’t want to continue, you can withdraw at any time.
- Any information that you share will be kept strictly confidential, except as required by law.
Why Join the VALUE Trial?
- Medical Care: Patients who take part in the VALUE trial will receive regular health check-ups from supportive medical professionals, providing standard of care treatment - at no cost.
- Improving Patient Care: Your participation might help us to discover new or improved treatments that could benefit patients around the world.
