Back to resultsA 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
Primary Purpose
Surgical Wound Dehiscence
Status
Terminated
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
PolyHeal 2
Polyheal
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Wound Dehiscence
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
Sites / Locations
- Soroka Medical Center
- Rambam Medical Center
- Western Galilee Hospital
- Souraski Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PolyHeal 2
PolyHeal
Arm Description
Negatively charged 5-micron polystyrene microspheres in Water For Injection
Negatively charged 5-micron polystyrene microspheres suspended in Dulbecco's Modified Eagle's Medium (DMEM)
Outcomes
Primary Outcome Measures
Achievement of at least (≥)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01679678
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Business considerations
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MediWound Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Dehiscence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PolyHeal 2
Arm Type
Experimental
Arm Description
Negatively charged 5-micron polystyrene microspheres in Water For Injection
Arm Title
PolyHeal
Arm Type
Active Comparator
Arm Description
Negatively charged 5-micron polystyrene microspheres suspended in Dulbecco's Modified Eagle's Medium (DMEM)
Intervention Type
Device
Intervention Name(s)
PolyHeal 2
Other Intervention Name(s)
PolyHeal, PolyHeal is a sterile medical device
Intervention Description
PolyHeal is a sterile medical device
Intervention Type
Device
Intervention Name(s)
Polyheal
Other Intervention Name(s)
PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in DMEM
Intervention Description
PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Berezovsky, MD
Organizational Affiliation
Head of Department of Plastic and reconstructive surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eyal Gur, MD
Organizational Affiliation
Head of Plastic and Reconstructive Surgery Department, Souraski Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leonid Kogan, MD
Organizational Affiliation
Head of Plastic Surgery Department Western Galilee Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yehuda Ulman, Proffesor
Organizational Affiliation
Head of Plastic surgery department ,Rambam Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka Medical Center
City
Beer Sheva
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Western Galilee Hospital
City
Naharia
Country
Israel
Facility Name
Souraski Medical Center
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
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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