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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

NCT03863054 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2021-09-27

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer
  • Non-healing Wound

Interventions

DEVICE

NATROX™ Topical Oxygen Therapy System

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

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Tang Tjun Yip · Singapore General Hospital

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-17
Primary Completion
2021-03-23
Completion
2021-05-31

Countries

  • Singapore

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 NCT03863054 on ClinicalTrials.gov