Case
Study1
Study1
Patient: 80-years-old Female
Clinical presentation: 68cm² VLU on left lower leg
Therapeutic outcome: ≥90% debridement and ≥75% granulation by day 7, STSG on week 1 and wound healing in 8 weeks
Treatment timeline
A Global Study for the Treatment of Venous Leg Ulcers with EscharEx
Referral Opportunity:
A Clinical Trial for Venous Leg Ulcer Patients
Now enrolling at 11 US sitesPhase 3Global, multicenter, double-blind
1 : 1Randomized to EscharEx® or gel vehicle
216Patients planned in this global trial
≤ 24 visitsOver approximately 6 months
Dear Healthcare Providers,
We invite you to refer your patients with venous leg ulcers to our ongoing VALUE clinical trial, exploring a new treatment of wound debridement. The VALUE phase 3 global clinical trial provides potential access to innovative enzymatic debridement, and an opportunity for your patients, suffering from VLU, to receive advanced and comprehensive medical treatment for their chronic wound.
The innovative treatment, EscharEx, is based on a sterile powder made of enzymes extracted from the pineapple plant mixed with excipients. When the EscharEx powder is mixed with sterile water it creates a gel mixture, easy to apply. EscharEx was proven in 3 former phase II clinical trials to remove fast and effectively non-viable tissue from the wound bed, superior to competitors. Moreover, EscharEx was shown to promote healthy granulation tissue, hence prepare the wound for healing faster and in higher incidence than competitors (Gel vehicle and non-surgical SOC treatments).
Why Refer Your Patients?
Advanced wound care at no cost
All study-related treatments, dressings, and compression therapy are provided at no cost.
Specialized, protocol-driven management
Patients receive frequent evaluation and care by experienced wound professionals, following a structured clinical protocol.
Support for difficult-to-heal wounds
Particularly appropriate for patients whose VLUs are slow to progress under standard care.
Reduced burden on your staff
Participation shifts intensive wound management to the clinical site, helping reduce staff time and resource demands.
Transportation and stipend support
Participants receive transportation support and compensation for their time.
Regulatory and ethical oversight
The trial is conducted under strict regulatory and ethical standards, including FDA oversight.
Demonstrates proactive care
Offering access to clinical research reflects a commitment to exploring advanced treatment options for patients and their families.
Results from former EscharEx trials
ChronEx Trial: Higher Incidence of Both Complete Debridement and Wound Bed Prepared
Complete Debridement Within the 2-Week Treatment Period
Wound Bed Prepared Within the 2-Week Treatment Period
EscharEx® achieved a significantly higher incidence of complete debridement and of Wound bed Prepared compared to both placebo (primary end point) and Non- Surgical SOC
Case
Study2
Study2
Patient: 30-years-old Male
Clinical presentation: 80.75cm² VLU on left leg
Therapeutic outcome: ≥90% debridement and ≥75% granulation by day 3, STSG on week 1 and wound healing in 2 weeks.
Treatment timeline
Case
Study3
Study3
Patient: 77-years-old Male
Clinical presentation: 5.4cm² VLU on Right lower leg
Therapeutic outcome: Complete debridement and complete granulation by day 3, STSG during week 1 and wound healing in 4 weeks.
Treatment timeline
Case
Study4
Study4
Patient: 68-years-old Female
Clinical presentation: 10.1cm² VLU on right lower leg
Therapeutic outcome: Complete debridement and complete granulation by day 3 and wound healing in 5 weeks.
Treatment timeline
Referral Process
Who is eligible?
Patients may be eligible if they meet these criteria
- Patients with venous leg ulcers, over 18 years of age
- Wound is present for at least 4 weeks but no longer than 18 months
- Target wound surface area is in the range of 2–25 cm²
- Between 50–100% of the wound area should be covered with non-viable tissue (e.g. fibrin / slough / necrotic tissue)
Key exclusion criteria
- Receiving dialysis treatment
- Signs of clinical infection of the wound or peri-wound, or signs of systemic infection, sepsis or osteomyelitis
- A significant decrease in arterial blood flow: ABI ≤ 0.70, TBI ≤ 0.50, or SPP / TCOM ≤ 40 mmHg
- Known sensitivity to pineapples, bromelain, papaya or papain, or latex proteins
- Poor nutritional status or poorly controlled diabetes (e.g. albumin < 2.5 g/dL, HbA1c > 12%, BMI > 48)
- Pentoxifylline within 2 weeks prior to screening, or venous ablation adjacent to the target wound within the past month
Exclusion criteria from the ClinicalTrials.gov listing. View all inclusion and exclusion criteria ↗
How to ReferNearest site Nearest site Nearest site Nearest site Nearest site Nearest site Nearest site Nearest site Nearest site Nearest site Nearest site
Find your nearest study site
1
Contact a study site near you for eligibility assessment if you have patients who meet the above criteria.
2
The site team will guide patients through enrollment.
Showing all 11 sites, grouped by state.
Northwell Comprehensive Wound Healing Center
Sally Kaplan, RN
516-233-3781
skaplan2@northwell.edu
Wound Care Center, NYU Langone, Long Island
Scott Gorenstein
516-663-8498
scott.gorenstein@nyulangone.org
The Mount Sinai Medical Center
Garismar Ramirez
Garismar.Ramirez@mountsinai.org
Rutgers Health, Clinical Research Unit
Mehreen Bhatti
973-972-3173
Mb2276@njms.rutgers.edu
Cutting Edge Research, LLC
Rhonda
740-474-3850
clinical1@wafl-ohio.com
University of Miami, Desai Medical Building
Leonela Espinoza
305-689-3376
lte17@med.miami.edu
Clinical Trial Network
Daniel Galvan
832-281-5253
dgalvan@ctntexas.com
Limb Preservation Platform, Inc.
Destiny Blackstone
559-431-1700
info@lppresearch.com
Angel City Research
Rose Jadulco
323-544-8992
rose@angelcityresearch.com
Center for Clinical Research
Research team
800-363-1069
Gayana@ccr-trials.com
ILD Research Center, INC
Eric Martinez
760-350-5080
Eric@ildresearch.com
Questions from referring clinicians
Is there a placebo arm?
Yes. Patients are randomly assigned to one of two groups. One group will receive the study medicine, and the other will receive a placebo, with 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 ingredients as the EscharEx® powder, but without the active enzymes. The study is double-blind.
What does participation involve for my patient?
Patients 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 the wound is healing. Patients receive frequent evaluation and care by experienced wound professionals, following a structured clinical protocol.
Is there any cost to patients?
All study-related treatments, dressings, and compression therapy are provided at no cost. Participants receive transportation support and compensation for their time.
What is informed consent?
Before joining the study, patients receive all the important information about its purpose, procedures, potential risks, and benefits. They have the opportunity to ask questions and decide whether they want to participate. Consent is given voluntarily and in writing, and patients can withdraw from the study at any time without providing a reason.
What is being measured in the VALUE trial?
The primary endpoints are the incidence of complete debridement (assessed up to 2 weeks) and time to complete wound closure (assessed up to 12 weeks). Other outcomes include complete granulation tissue, time to wound bed preparation, pain (NPRS), target wound infection, adverse events and immunogenicity.
Where can I find the full protocol summary?
The full listing, including all inclusion and exclusion criteria, is on ClinicalTrials.gov (NCT06568627). Patients can find information for themselves at www.thevaluetrial.com.