CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
NATROX™ Topical Oxygen Therapy Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03863054
NCT03863054N/ACompleted
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An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (NATROX™) on the Rates of Healing of Chronic Diabetic Foot Ulcers

Singapore General Hospital·observational·Posted Mar 5, 2019·Updated Sep 27, 2021

In Brief

An observational study evaluating NATROX™ Topical Oxygen Therapy System for Diabetic Foot Ulcer and Non-healing Wound. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This study aims to evaluate the effectiveness of NATROX™ Topical Oxygen Wound Therapy for subjects with non-healing foot ulceration. Subjects will be treated with standard care for 4 weeks. If the wound is not reduced by more than 40%, NATROX™ will be applied for the next 12 weeks. Throughout the study period, wound measurements will be taken to measure wound reduction.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcer, Non-healing Wound
CountriesSingapore
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 5, 2019
Enrollment StartAug 17, 2018
Primary CompletionMar 23, 2021
Study CompletionMay 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.3 years ago

Interventions

NATROX™ Topical Oxygen Therapy Systemdevice

A small battery-powered electrochemical "oxygen generator" to concentrate atmospheric oxygen and feed to wound site through a dressing-like "oxygen distribution system"