A Study to Evaluate the Safety and the Efficacy of EscharEx (EX-02 Formulation) in Debridement of Venous Leg Ulcers
- Conditions
- Venous Leg Ulcer
- Interventions
- Drug: EscharEx (5% EX-02 formulation)Drug: Gel VehicleDrug: Non-surgical standard of care (NSSOC)
- Registration Number
- NCT03588130
- Lead Sponsor
- MediWound Ltd
- Brief Summary
This study is a multicenter, prospective, randomized, placebo controlled, adaptive design study performed to assess the safety and the efficacy of 5% EscharEx (EX-02) compared to Gel Vehicle (placebo) and non-surgical standard of care (NSSOC), in debridement of Venous Leg Ulcers (VLU) (in a ratio of 2:2:1) in debridement of VLU.
The main objective of this study is:
To assess the safety and the efficacy of EscharEx (EX-02 formulation) compared to Gel Vehicle (placebo) and non-surgical standard of care (NSSOC), in debridement of Venous Leg Ulcers (VLU).
120 randomized adult patients with VLU that fail to heal for 4 weeks to 2 years, and with \>50% non-viable tissue (necrotic/slough/fibrin) on the VLU. The maximum number of patients to be enrolled is 160.
The total duration of the study of each participating subject is up to 17 weeks: screening (1 week) + Daily visit period (up to 2 weeks) + Twice-weekly visits period (2 weeks) + Weekly visits period (10 weeks) + closure confirmation (up to 2 weeks, if applicable).
Each patient will go through 4 periods during the trial:
1. Screening period (2 visits, 7 \[+2\] days apart). Including: recording demographics, medical history and concomitant medications, vital signs, physical examination, clinical laboratory tests, wound photography and assessments and questionnaires (pain, wound status and QoL). During this period, wounds will be treated by standard treatment (e.g. appropriate dressing, compression bandage) per investigator discretion, with the exclusion of mechanical and surgical debridement.
During the one week screening period, patients whose wound size (surface area, as measured by eKare inSightTM) decreases by more than 20 percent will be excluded.
2. Daily visits period (up to 8 daily site visits within up to 14 days): During the Daily visit period, the patient will arrive daily to site visits. During each visit, adverse events, concomitant medication, vital signs and pain will be recorded, the wound will be washed, photographed and assessed for wound size (by eKare inSightTM), % of non viable tissue (by clinical assessment), and wound healing status (assessed clinically).
Eligible patients will be randomized into one of the study arms: EX-02, or Gel Vehicle (Placebo), or NSSOC in a 2:2:1 ratio. Patients will be treated with up to 8 daily 24±3 hours applications or until complete debridement is achieved, whichever occurs first.
On the weekends between treatments of EX-02 or Gel material, the wound will be dressed with a compatible dressing, and by compression therapy. Patients treated with NSSOC continue using NSSOC during the weekend according to label or instructions for use, and compression therapy.
3. Twice-weekly visits period (4 visits within 14 days): the patients will be followed twice weekly for two weeks, (4 visits within 14 days). During each visit, safety parameters will be recorded (AEs, concomitant medications, pain, vital signs), the wound will be washed, photographed and assessed for wound size (by eKare inSightTM), % of nonviable tissue (by clinical assessment), and wound healing status (assessed clinically).
The investigator will clinically assess complete debridement, upon achieving a viable wound bed after removal of all non-viable tissue, suitable for initiation of the wound healing stage.
4. Weekly visits period (up to10 visits within up to 10 weeks): patients will be followed once weekly for 10 weeks or until complete wound closure was achieved, (up to10 visits within up to 10 weeks). During each weekly visit, safety parameters will be recorded (AEs, concomitant medications, pain, vital signs), the wound will be washed, photographed and assessed for wound size (by eKare inSightTM), % of nonviable tissue (by clinical assessment), and wound healing status (assessed clinically).
The investigator will clinically assess complete debridement, upon achieving a viable wound bed after removal of all non-viable tissue, suitable for initiation of the wound healing stage.
Complete wound closure defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits, 2 weeks apart will be assessed clinically. Thus, if closure occurs close to the end of weekly visit period, i.e. on 9th or 10th visit of the weekly period, an additional confirmation visit will be performed 2 weeks later.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EscharEx (5% EX-02 formulation) EscharEx (5% EX-02 formulation) Debridement will be performed with 5% EX-02 for 24±3 hours, up to 8 applications Gel Vehicle Gel Vehicle Debridement will be performed with Gel vehicle for 24±3 hours, up to 8 applications Non-surgical standard of care (NSSOC) Non-surgical standard of care (NSSOC) Debridement will be performed with NSSOC (Santyl or commercially approved Hydrogel) per routine procedures, until complete debridement is achieved
- Primary Outcome Measures
Name Time Method Incidence of complete debridement in EX-02 vs. Gel Vehicle arms, scored dichotomously (yes/no), clinically assessed up to 8 applications, within 14 days The clinical assessor will define complete debridement, after each application during the daily visits period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
ILD Research Center
🇺🇸Carlsbad, California, United States
Stanford
🇺🇸Redwood City, California, United States
Limb Preservation Platform, Inc.
🇺🇸Fresno, California, United States
Felix Sigal. D.P.M, PC
🇺🇸Los Angeles, California, United States
Medstar Health Georgetown University
🇺🇸Washington, District of Columbia, United States
Barry University Clinical Research
🇺🇸Miami Beach, Florida, United States
INTEGRAL - Clinical Trials Solutions
🇺🇸Doral, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Bey Lea Ambulatory Surgical Center
🇺🇸Toms River, New Jersey, United States
AZH Wound Center
🇺🇸Milwaukee, Wisconsin, United States
Hopitaux Universitaires de Geneva
🇨🇭Geneva, Canton, Switzerland
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Mount Sinai St. Luke's Hospital
🇺🇸New York, New York, United States
NYU Winthrop Hospital
🇺🇸Mineola, New York, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Center for Clinical Research Inc.
🇺🇸San Francisco, California, United States
Boston Medical Center/Boston University Medical Center
🇺🇸Boston, Massachusetts, United States
C & R Research Services USA, Inc
🇺🇸Coral Gables, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
South Shore Health System, Center for Wound Healing
🇺🇸Weymouth, Massachusetts, United States
Advanced Foot & Ankle Center
🇺🇸Las Vegas, Nevada, United States
Atlantic Health System - Overlook Wound Care Center
🇺🇸Summit, New Jersey, United States