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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

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

Tracking Information
First Submitted Date  ICMJE August 20, 2012
First Posted Date  ICMJE September 6, 2012
Last Update Posted Date March 30, 2016
Study Start Date  ICMJE November 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Surgical Wound Dehiscence
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 29, 2016)
15
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2012)
20
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01679678
Other Study ID Numbers  ICMJE MWPH-2012-08-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MediWound Ltd
Study Sponsor  ICMJE MediWound Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP