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Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds

NCT00552643 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-10-28

No results posted yet for this study

Summary

The objective of this study is to evaluate the performance of Polyheal-1 compared to Saline in the treatment of recalcitrant wounds including venous, post-operative and post-traumatic chronic wounds with different etiologies including wounds with exposed bone and/or tendons.

Conditions

  • Wounds and Injuries

Interventions

DEVICE

Suspension of polystyrene beads (POLYHEAL 1)

Topical application of Polyheal 1 (15 mL/200cm2 of wound area, TID, 28 days, one cycle

DEVICE

Saline (0.9% NaCl)

Saline topical application 15 mL/200cm2 of wound area, TID, 28 days, one cycle

Sponsors & Collaborators

  • Polyheal Ltd.

    lead INDUSTRY

Principal Investigators

  • Gavriel Zeilig, DM · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-05-31

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 NCT00552643 on ClinicalTrials.gov