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NCT03588130 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and the Efficacy of EscharEx (EX-02 Formulation) in Debridement of Venous Leg Ulcers
A Phase 2 study of Venous Leg Ulcer, sponsored by MediWound.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT03588130 is a Phase 2 study of Venous Leg Ulcer that has completed, run by MediWound. The registered enrollment target is 120 participants, below the 242-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT03588130, a Phase 2 study of Venous Leg Ulcer, has completed, sponsored by MediWound.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG EscharEx (5% EX-02 formulation)
- DRUG Gel Vehicle
- DRUG Non-surgical standard of care (NSSOC)
Study Locations (20)
California
- ILD Research Center - Carlsbad
- Limb Preservation Platform, Inc. - Fresno
- Felix Sigal. D.P.M, PC - Los Angeles
- Stanford - Redwood City
- Center for Clinical Research Inc. - San Francisco
Florida
- C & R Research Services USA, Inc - Coral Gables
- INTEGRAL - Clinical Trials Solutions - Doral
- University of Miami - Miami
- Barry University Clinical Research - Miami Beach
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Medical Center/Boston University Medical Center - Boston
- South Shore Health System, Center for Wound Healing - Weymouth
New York
- NYU Winthrop Hospital - Mineola
- Mount Sinai St. Luke's Hospital - New York
- Stony Brook University Hospital - Stony Brook
New Jersey
- Atlantic Health System - Overlook Wound Care Center - Summit
- Bey Lea Ambulatory Surgical Center - Toms River
District of Columbia
- Medstar Health Georgetown University - Washington D.C.
Illinois
- Northwestern University - Chicago
Nevada
- Advanced Foot & Ankle Center - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-12-02 |
| Est. Completion | 2022-03-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03588130
The ClinicalTrials.gov registry entry for NCT03588130 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (50% lower). The listed sponsor is MediWound, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Venous Leg Ulcer appearing as the primary indexed condition, and to 3 interventions - of which EscharEx (5% EX-02 formulation) is the first listed.
NCT03588130 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03588130 about?
NCT03588130 is a clinical study titled "A Study to Evaluate the Safety and the Efficacy of EscharEx (EX-02 Formulation) in Debridement of Venous Leg Ulcers". 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...
What is the current status of trial NCT03588130?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2019-12-02. Estimated completion is 2022-03-23.
What conditions does trial NCT03588130 study?
This clinical trial studies the following conditions: Venous Leg Ulcer.
What interventions are being tested in trial NCT03588130?
The interventions under investigation include: EscharEx (5% EX-02 formulation) (DRUG), Gel Vehicle (DRUG), Non-surgical standard of care (NSSOC) (DRUG).
Who is sponsoring clinical trial NCT03588130?
This trial is sponsored by MediWound, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03588130 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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