Efficacy and Safety Study of EscharEx to Treat (Debride) Hard to Heal Wounds

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by MediWound Ltd
Sponsor:
Information provided by (Responsible Party):
MediWound Ltd
ClinicalTrials.gov Identifier:
NCT02020746
First received: December 19, 2013
Last updated: June 1, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention 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
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

Resource links provided by NLM:


Further study details as provided by MediWound Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Rate of complete wound closure [ Time Frame: 12 weeks post debridement ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
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)
Arms Assigned Interventions
Active Comparator: EscharEx
Enzymatic debridement
Drug: EscharEx
Placebo Comparator: Gel Vehicle
Control arm
Drug: Gel Vehicle

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Inclusion Criteria
  • Patients, men or women, are between 18 and 90 years of age.
  • Patient with venous leg ulcer or diabetic (lower extremity) ulcer or traumatic/post operative wound (determined by medical history and physical examination)
  • Wound is not healing for at least 4 weeks
  • The necrotic/slough/fibrin non-viable tissue area is at least 50% of wound area (assessed by clinical evaluation)
  • Wound surface area (length X width) is in the range of 5 - 100 cm2 (assessed by Acetate tracing)
  • Patient understands the nature of the procedure, able to adhere to the protocol regimen, and provides written informed consent prior to any study procedure
  • The Wound is classified as a wound involving full skin thickness but not underlying tissue or deeper wound penetrating to cavities, bone, or joint capsule

Exclusion Criteria

  • Evidence of active osteomyelitis of target organ,
  • Patients with more than one hard to heal wounds with an area greater than or equal to 2cm2,
  • Presence of purulent discharge, deep-tissue abscess, cellulitis extending >2 cm around the wound, gangrene or signs of systemic infection,
  • Wound size decreased by > 20% after 1 week of standard-of-care-only period (screening period), (assessed by Acetate tracing)
  • Patients with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by Silver sulfadiazine (SSD) pseudoeschar (e.g. pseudoeschar as a result of SSD treatment),
  • Ankle-Brachial Index (ABI) ≤ 0.8
  • Wound has sinus tracts or tunnels extending under healthy tissue,
  • Patients undergoing renal or peritoneal dialysis,
  • Recent history (less than 4 weeks) of myocardial infarction (MI) or concurrent acute injury or disease that might compromise the patient's welfare,
  • Any condition that would preclude safe participation in the study: evidence of significant hematological (severe pre-existing coagulation disorder), cardiovascular, liver or neoplastic disease, or any other immediate life threatening condition,
  • Patient is currently receiving, or has received at any time within one month prior to enrollment, any medications or treatments known to affect the wound healing processes; these include: chronic systemic steroid intake with topical skin changes (thin, fragile with multiple hematomas and previous laceration history, immuno-suppressive drugs, radiation therapy and chemotherapy.
  • History of allergy or atopic disease or a known sensitivity to pineapples, papaya, bromelain or papain,
  • Pregnant women (positive pregnancy test) or nursing mothers,
  • Participation in another investigational drug trial within 30 days prior to enrollment or anticipated participation while enrolled in the study,
  • Concurrent use of non-approved drugs or alcohol abuse.
  • Patients with poor nutritional status (albumin < 2.5g/dl), poor diabetic control (HbA1c > 12%), anemia (hemoglobin<9 g/dL), a leukocyte counts < 4,000// μl or >15000/μl, abnormal liver function (AST, ALT>2 x upper limit of normal range), renal failure (Cr > 3 mg/dl);
  • Mentally incapacitated adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc),
  • Patients with general skin disorders (Psoriasis, Panniculitis, ect) that might deteriorate as a result of local trauma.
  • Patients with skin disorders unrelated to the wound that are presented adjacent to the wound
  • Clinical suspicion of skin cancer associated with the wound (e.g, BCC, SCC), which was not ruled out by biopsy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02020746

Contacts
Contact: Limor Dinur-Klein, PhD 972543301324 limord@mediwound.co.il
Contact: Efrat Hazan 972523878830 efrath@mediwound.co.il

Locations
Israel
Rambam hospital Recruiting
Haifa, Israel
Contact: Yehuda Ullman, MD       yullmann@rambam.health.gov.il   
Principal Investigator: Leonid Kogan, MD         
Sponsors and Collaborators
MediWound Ltd
  More Information

No publications provided

Responsible Party: MediWound Ltd
ClinicalTrials.gov Identifier: NCT02020746     History of Changes
Other Study ID Numbers: MW 2013-07-10
Study First Received: December 19, 2013
Last Updated: June 1, 2014
Health Authority: Israel : Ministry of Health (MOH)

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Leg Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014