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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

NCT01679678 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-03-30

No results posted yet for this study

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.

Conditions

  • Surgical Wound Dehiscence

Interventions

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

Sponsors & Collaborators

  • MediWound Ltd

    lead INDUSTRY

Principal Investigators

  • Alex Berezovsky, MD · Head of Department of Plastic and reconstructive surgery

  • Eyal Gur, MD · Head of Plastic and Reconstructive Surgery Department, Souraski Medical Center

  • Leonid Kogan, MD · Head of Plastic Surgery Department Western Galilee Hospital

  • Yehuda Ulman, Proffesor · Head of Plastic surgery department ,Rambam Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01679678 on ClinicalTrials.gov