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Evaluation of Topical Wound Oxygen (two2) Therapy

NCT00871312 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2014-01-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of the Topical Wound Oxygen (two2) therapy system on the healing of diabetic lower extremity ulcers.

Conditions

  • Diabetic Ulcer

Interventions

DEVICE

Topical wound oxygen therapy

90 minutes 4 days per week Active Topical Oxygen Therapy

DEVICE

Topical wound oxygen Placebo

90 mins per day 4 days per week Placebo Therapy

Sponsors & Collaborators

  • AOTI Ltd.

    lead INDUSTRY

Principal Investigators

  • Laura E Edsberg, Ph.D. · Daamen College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States
  • Canada

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 NCT00871312 on ClinicalTrials.gov