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Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers

NCT01913704 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-03-18

No results posted yet for this study

Summary

The purpose of this study is to determine the effectiveness of the NatroxTM Topical Oxygen device versus a placebo in patients with non-healing leg ulceration in conjunction with standard best practice.

Conditions

  • Skin Ulcer Venous Stasis Chronic
  • Mixed Arteriovenous Leg Ulcer

Interventions

DEVICE

NatroxTM Device

The NatroxTM device is a system to deliver oxygen from an oxygen generator topically to the wound via a proprietary device. The NatroxTM ODS oxygen delivery device will be applied to the wound and attached to the oxygen generator and switched on at the time of first dressing application at enrolment. Secondary dressings will then be applied. The oxygen delivery device will be removed and reapplied at each dressing change for a treatment period of 6 weeks.

Sponsors & Collaborators

  • Inotec AMD Limited

    lead INDUSTRY

Principal Investigators

  • R Gurlich, Professor · Fakultni Nemocnice Kralovske Vinohrady Prague

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-05-31
Completion
2014-10-31

Countries

  • Czechia

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 NCT01913704 on ClinicalTrials.gov