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

MediWound

Status and phase

Terminated

Phase 2

Conditions

Surgical Wound Dehiscence

Treatments

Device: PolyHeal 2

Device: Polyheal

Study type

Interventional

Funder types

Industry

Identifiers

NCT01679678

MWPH-2012-08-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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