Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Foot Ulcer Non-healing Wound

Keywords

Topical OxygenWound Management

Outcome Measures

Primary Outcomes (1)

Percentage change in ulcer size
after 12 weeks of NATROX™ therapy, relative to baseline measurement
12 weeks after NATROX™ fitted

Secondary Outcomes (6)

Absolute Closure Number
16 weeks after last patient enrolled
Wound Closure Rate relative to the 4-week run in period
16 weeks after last patient enrolled
Number of dressing episodes during the study period
16 weeks after enrolment
Number of infection episodes
16 weeks after enrolment
Diabetic Foot Ulcer Scale
Baseline (week 0), Week 4, Week 8, Week 12 and Week 16 post enrolment
+1 more secondary outcomes

Study Arms (2)

>40% wound area reduction after 1 month

Subjects to continue with standard practice for the next 12 weeks, or until the wound has completely healed.

<40% wound area reduction after 1 month

Subjects to be fitted with NATROX™ after 1 month, over a period of 12 weeks or until the wound has completely healed.

Device: NATROX™ Topical Oxygen Therapy System

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"

<40% wound area reduction after 1 month

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years - 90 Years

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Subjects with non-healing Diabetic Foot Ulcers that has been persistent for more than 3 months, or less than 50% healing observed within 1 month for amputation sites.

You may qualify if:

A diabetic foot ulcer greater than 12 weeks and less than 18 months in duration

Sponsors & Collaborators

Singapore General Hospital
Otherlead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Related Publications (14)

Blackman E, Moore C, Hyatt J, Railton R, Frye C. Topical wound oxygen therapy in the treatment of severe diabetic foot ulcers: a prospective controlled study. Ostomy Wound Manage. 2010 Jun;56(6):24-31.
PMID: 20567051BACKGROUND
Driver VR, Yao M, Kantarci A, Gu G, Park N, Hasturk H. A prospective, randomized clinical study evaluating the effect of transdermal continuous oxygen therapy on biological processes and foot ulcer healing in persons with diabetes mellitus. Ostomy Wound Manage. 2013 Nov;59(11):19-26.
PMID: 24201169BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

Tang Tjun Yip
Singapore General Hospital
PRINCIPAL INVESTIGATOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 5, 2019

Study Start

August 17, 2018

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

>40% wound area reduction after 1 month

<40% wound area reduction after 1 month

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (14)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

>40% wound area reduction after 1 month

<40% wound area reduction after 1 month

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (14)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations