A Study, Performed in Subjects With Post Traumatic-post Surgical ,Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of PolyHeal-2 Versus PolyHeal in Once Daily Regimen

• ClinicalTrials.gov Identifier: NCT01679678
• Recruitment Status: Terminated
• First Posted: September 6, 2012
• Last Update Posted: March 30, 2016
• Sponsor: MediWound Ltd
• Information provided by (Responsible Party): MediWound Ltd

Tracking Information

• First Submitted Date: August 20, 2012
• First Posted Date: September 6, 2012
• Last Update Posted Date: March 30, 2016
• Study Start Date: November 2012
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 1, 2012): Achievement of at least (≥)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase) [ Time Frame: 4 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study, Performed in Subjects With Post Traumatic-post Surgical ,Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of PolyHeal-2 Versus PolyHeal in Once Daily Regimen
• Official Title: A Double Blind, Randomized, Controlled Study, Performed in Subjects With Post Traumatic-post Surgical, Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of Polyheal-2 vs PolyHeal in Once Daily Regimen
• Brief Summary: This is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical control. The study will enroll adult subjects with post traumatic/post surgical, venus insufficiency and diabetic hard to heal wounds who meet the entrance criteria which will be followed for 12 weeks.

Detailed Description

Subjects will undergo screenibg period of up to two weeks. Following to eligibilidy confirmation subjects will be randomized into one of the two treatment groups and treated with study device once daily for 4 weeks.

Continuation of study device for additional period is based on wound healing progression and under investigator's discretion.

Subjects will be followed up weekly following to 4 weeks of active treatment for additional 8 weeks untol week 12.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Surgical Wound Dehiscence

Intervention

• Device: PolyHeal 2
  PolyHeal is a sterile medical device
  Other Names:

  • PolyHeal
  • PolyHeal is a sterile medical device
• Device: Polyheal
  PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in
  Other Name: PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in DMEM

Study Arms

• Experimental: PolyHeal 2
  Negatively charged 5-micron polystyrene microspheres in Water For Injection
  Intervention: Device: PolyHeal 2
• Active Comparator: PolyHeal
  Negatively charged 5-micron polystyrene microspheres suspended in Dulbecco's Modified Eagle's Medium (DMEM)
  Intervention: Device: Polyheal

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 29, 2016): 15
• Original Estimated Enrollment (submitted: September 1, 2012): 20
• Actual Study Completion Date: August 2014
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Hard to heal/chronic post traumatic post surgical ,venus insufficiency and diabetic wound refractory to healing at least 4 weeks prior to study treatment (one or more target wound/s will be eligible per each subject to be treated by the same agent)
• Subjects who are able to read, understand, and sign the informed consent form. In case of compromised mental capacity, approval and signature of a legal guardian is required.

Exclusion Criteria:

• Presence of a systemic infection or significant local infection with copious purulent drainage, fluids drainage, gangrene, or cellulites, or necrosis at the target wound site, as well as nonviable tissue, sinus tracts or tunnels that cannot be removed by debridement.
• Wounds with exposed bones, tendons or ligaments
• Wounds with exposed orthopedic implants
• Wounds with exposed breast prostheses
• Uncontrolled diabetes with HbA1c >11%
• Subjects with BMI greater than 35kg/m2
• Woman who are pregnant or nursing, or of childbearing potential and are not using adequate contraception
• Participation in another clinical drug/device trial within 30 days prior to the Screening visit or during this study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT01679678
• Other Study ID Numbers: MWPH-2012-08-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: MediWound Ltd
• Study Sponsor: MediWound Ltd
• Collaborators: Not Provided

Investigators

• Principal Investigator: Alex Berezovsky, MD; Head of Department of Plastic and reconstructive surgery
• Principal Investigator: Eyal Gur, MD; Head of Plastic and Reconstructive Surgery Department, Souraski Medical Center
• Principal Investigator: Leonid Kogan, MD; Head of Plastic Surgery Department Western Galilee Hospital
• Principal Investigator: Yehuda Ulman, Proffesor; Head of Plastic surgery department ,Rambam Medical Center

• PRS Account: MediWound Ltd
• Verification Date: March 2016