Efficacy and Safety Study of EscharEx to Treat (Debride) Hard to Heal Wounds
The main objective of this study is to assess the safety and the efficacy of EscharEx in preparing the wound's bed in patients with hard to heal venous leg ulcers, diabetic lower extremity ulcers and traumatic/post operative wounds.
This study will be a multi-center, blinded, randomized, controlled study intended to demonstrate superiority of EscharEx debriding treatment over the Gel Vehicle control treatment in patients with hard to heal wounds.
72 adults with >50% necrotic/slough/fibrin non-viable tissue on a hard to heal wound (venous leg ulcer, diabetic lower extremity ulcer or traumatic/ post operative wound) between 5 cm2 and 100 cm2 (surface area), will be enrolled into the study.
Patients will undergo a 1 week screening period (2 visits) which will include: record of demographics, medical history and concomitant medications, vital signs, physical examination, clinical laboratory tests, wound photography and assessments and questionnaires (wound status and quality of life). During this period wounds will be cleansed with normal saline and the wound will be dressed with moist-to-moist saline gauze. During this screening period, subjects whose study wound size (surface area) decreases by a stated amount (i.e. > 20 percent) will be excluded. Following completion of the screening process, eligible patients will be randomized to either EscharEx or Gel vehicle debridement treatments. Treatment will be performed once daily up to 10 applications (up to 10 visits) or until complete debridement is achieved, whichever occurs first. The duration of each application is 4 hours. Following each application the wound will be washed photographed and assessed for wound size, removal of nonviable tissue and change in granulation tissue (by digital planimetry software), wound status, and safety parameters. Subsequent to each debridement treatment the wound will be dressed with moist-to-moist saline gauze. Following completion of the debridement treatment period, patients will be treated according to standard procedures and evaluated (wound assessments) once a week until complete wound closure for up to 12 weeks from last application (up to 12 visits). For patients who achieved wound closure, additional 3 months (3 visits) follow up of wound closure recurrence will be conducted. Quality of life (QoL) will be evaluated at the last wound closure follow-up visit and 3 months post wound closure follow-up period (for all patients).
Hard to Heal Wounds
Venous Leg Ulcers
Diabetic Lower Extremity Ulcers
Traumatic/ Post Operative Wounds
Drug: Gel Vehicle
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Prospective, Randomized, Vehicle Controlled, Blinded Study Performed in Subjects With Hard to Heal Wounds, to Evaluate the Efficacy and Safety of Enzymatic Debridement With EscharEx|
- Incidence of complete debridement (non-viable tissue removal) at the end of Incidence of complete debridement (non-viable tissue removal) [ Time Frame: 10 treatment days ] [ Designated as safety issue: No ]
- Rate of complete wound closure [ Time Frame: 12 weeks post debridement ] [ Designated as safety issue: No ]
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Active Comparator: EscharEx
Placebo Comparator: Gel Vehicle
|Drug: Gel Vehicle|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02020746
|Contact: Limor Dinur-Klein, PhDfirstname.lastname@example.org|
|Contact: Efrat Hazanemail@example.com|
|Contact: Yehuda Ullman, MD firstname.lastname@example.org|
|Principal Investigator: Leonid Kogan, MD|