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Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers

NCT00998673 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2015-07-14

No results posted yet for this study

Summary

Silica Gel Fiber is a bioresorbable, inorganic silica gel fibre patch promoting skin tissue growth and enhanced wound healing for all types of chronic wounds. It is applied as patch and will be hold in place by a secondary dressing for maintaining the moist wound environment. The study is aimed to demonstrate superiority over a standard wound treatment for chronic venous leg ulcers. The primary efficacy variable is time to healing.

Conditions

  • Venous Ulcer

Interventions

DEVICE

Silica Gel Fiber

Silica Gel Fiber (SGF) applications as required

DEVICE

Standard-of-Care

Standard-of-Care with dressing changes twice per week using Mepitel and Mepilex wound dressings

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Germany

Study Locations

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Entities

Companies

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 NCT00998673 on ClinicalTrials.gov