Clinical trial NCT01679678: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Surgical Wound Dehiscence
Lead sponsor: MediWound Ltd
Sponsor class: INDUSTRY
First posted: 2012-09-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Achievement of at least (≥)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Naharia
country: Israel
facility: Western Galilee Hospital
city: Tel Aviv
country: Israel
facility: Souraski Medical Center
Study officials:
affiliation: Head of Department of Plastic and reconstructive surgery
name: Alex Berezovsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of Plastic and Reconstructive Surgery Department, Souraski Medical Center
name: Eyal Gur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of Plastic Surgery Department Western Galilee Hospital
name: Leonid Kogan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of Plastic surgery department ,Rambam Medical Center
name: Yehuda Ulman, Proffesor
role: PRINCIPAL_INVESTIGATOR
References: