Efficacy and Safety Study of EscharEx to Treat (Debride) Hard to Heal Wounds
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|ClinicalTrials.gov Identifier: NCT02020746|
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : August 31, 2018
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, assessor 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 + 24 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 200 cm2 (surface area in stage 1) or 3 cm2 - 150 cm2 (in stage 2), 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 treated by standard treatment per the decision of the physician. During this screening period, subjects whose study wound size (surface area) decreases by more than 20 percent will be excluded. Following completion of the screening process, eligible patients will be randomized to either EscharEx or Gel vehicle debridement treatments. In stage 1 (72 patients): Treatment will be performed for up to 10 applications or until complete debridement is achieved, whichever occurs first. In stage 2 (24 patients): Treatment will be performed for up to 8 applications or until complete debridement is achieved, whichever occurs first. 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 (except when successive 24h or 48h treatments are performed, in the second stage). 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). Only during the first stage of the study, for patients who achieved wound closure, additional 3 monthly (3 visits) follow- up visits of wound closure recurrence will be conducted. Quality of life (QoL) will be evaluated at the last follow-up visit - 3 months post wound closure follow-up period. For patients who didn't achieve wound closure only the 3 months FU visit will be conducted. For patients enrolled at the second stage, if wound closure was achieved at the 12 weeks follow-up, additional visit will be performed 2 weeks later to confirm wound closure.
|Condition or disease||Intervention/treatment||Phase|
|Hard to Heal Wounds Venous Leg Ulcers Diabetic Lower Extremity Ulcers Traumatic/ Post Operative Wounds||Drug: EscharEx Drug: Gel Vehicle||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||111 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Multicenter, International, Prospective, Randomized, Vehicle Controlled, Assessor Blinded Study Performed in Subjects With Hard to Heal Wounds, to Evaluate the Efficacy and Safety of Enzymatic Debridement With EscharEx|
|Actual Study Start Date :||July 24, 2014|
|Actual Primary Completion Date :||December 5, 2017|
|Actual Study Completion Date :||June 4, 2018|
Active Comparator: EscharEx
Placebo Comparator: Gel Vehicle
Drug: Gel Vehicle
- Incidence of complete debridement (non-viable tissue removal) at the end of the debridement period assessed by the blinded assessor by clinical evaluation. [ Time Frame: up to 10 treatment days ]
- Rate of complete wound closure [ Time Frame: 12 weeks post debridement ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020746
|Rambam MC - Plastic surgery ward|
|Kfar Saba, Israel|
|HaSharon hospital, Rabin MC|
|Petah Tikva, Israel|
|Ramat Gan, Israel|