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

Surgical Wound Dehiscence Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01679678
• Other study ID #: MWPH-2012-08-01
• Status: Terminated
• Phase: Phase 2
• First received: August 20, 2012
• Last updated: March 29, 2016
• Start date: November 2012
• Est. completion date: August 2014

Study information

• Verified date: March 2016
• Source: MediWound Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgical Wound Dehiscence

Intervention

Device:
• PolyHeal 2
PolyHeal is a sterile medical device
• Polyheal
PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Beer Sheva
Israel	Rambam Medical Center	Haifa
Israel	Western Galilee Hospital	Naharia
Israel	Souraski Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
MediWound Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of at least (=)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase)		4 weeks	No