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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: MediWound Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Wound Dehiscence

Interventions

Type	Name	Description
DEVICE	PolyHeal 2	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

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2012-09-06
• Last updated: 2016-03-30

Locations

4 sites across 1 country: Israel