Can Topical Oxygen Therapy (Natrox™) Improve Wound Healing in Diabetic Foot Ulcers?

November 5, 2015 updated by: Unity Health Toronto

Diabetic foot complications care represent a significant burden to the Canadian healthcare system. The estimated annual expenditure in Canada for diabetic foot ulcers is more than $150 million. A small sized randomized controlled trial (n=17) investigating the use of topical oxygen therapy (n=9) against placebo (n=8) for diabetic ulcers was done recently and showed a 87% average reduction of ulcer size in treatment group versus 46% average reduction in the control group (p<0.05).

Despite the standards of care used today in diabetic foot ulcer treatment, wounds may be non-healing when they do not heal within the appropriate time frame expected by an experienced clinician. Current diabetic foot ulcer standards of care include: full medical assessment in all cases, surgical intervention where indicated and local treatment of the ulcer.

Given the scarcity of controlled trials specifically designed to review the effects of topical oxygen in ulcer care, this study will contribute to the understanding of the management of these ulcers by assessing the reductions in ulcer size achieved using Natrox™ topical oxygen therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Diabetic foot complications care represent a significant burden to the Canadian healthcare system. The estimated annual expenditure in Canada for diabetic foot ulcers is more than $150 million. Topical oxygen therapy has historically been recognized as essential for its antibiotic properties and as a nutrient. A number of studies have suggested that this method of treatment may contribute to better healing of wounds, particularly in ulcers. The Natrox™ oxygen delivery system (ODS) is a device designed to overcome a number of problems associated with previous methods of oxygen therapy by delivering continuous oxygen to the ulcer bed through a dressing. It consists of a small battery-powered oxygen concentrator which processes oxygen from air, is portable, and can be held in place by a lightweight strap. In this study, we will seek to determine the effectiveness of the Natrox™ Topical Oxygen device in patients with non-healing diabetic foot/leg ulceration in conjunction with standard best practice. The Diabetic foot ulcer standards of care include:

  • Full medical assessment in all cases.
  • Surgical operation/Intervention where indicated.
  • Local treatment of the ulcer (debridement followed by ulcer care according to "modern ulcer healing" standards and management of diabetes.)

In both the treatment group and the control group, comparative changes in ulcer surface area will be measured over a period of 8 weeks to analyze wound healing.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Diabetic foot ulcer, which has had optimum multi-disciplinary team management for >4 weeks
  2. No planned treatment to arterial disease
  3. No planned surgical intervention
  4. Patients aged >18 years.
  5. Patients who understand the study, agree to adhere to the treatment and are able to give consent
  6. Patients who can be followed by the same investigating team for the whole period of their participation in the study

Exclusion Criteria

  1. Presence of invasive infection requiring intravenous antibiotics
  2. Presence of Methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aureus in the swab cultures
  3. Pure Neuropathic ulcer with no arterial insufficiency unless they fail to heal within 12 weeks of optimum management
  4. Significant reduced immunity or high dose corticosteroids (>10mg Prednisolone) or other second line immune-suppressant
  5. Need for total contact cast
  6. Patients with a known sensitivity to any of the components of the evaluation device
  7. Patients with known or suspected malignancy in the ulcer or surrounding tissue.
  8. Patients who do not have the physical or mental capacity, or a significant other with the ability to change the Natrox™ battery pack on a daily basis
  9. Patients who present with more than 10% of the ulcer surface area covered in hard eschar
  10. Patients with ulcer surface area of more than 10x10cm
  11. Patients who are participating in another clinical study for ulcer management
  12. Patients with a known history of poor compliance with medical treatment
  13. Patients who are unable to understand the aims of the study and not give informed consent
  14. Pregnant female patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Natrox treatment group
In this group, all subjects will have the Natrox™ ODS will be applied to the ulcer and attached to the active Natrox™ Oxygen Generator using the tubing provided or regular dressing will be used. Dressings according to the standard practice guidelines will be used. Patients in this group will continue to receive treatment as described by the diabetic foot ulcer standard of care. The ulcer will be photographed at biweekly intervals for a period of 8 weeks to analyze ulcer surface area using a standardized digital imaging software.
Device: Natrox™ Oxygen Delivery System (ODS)
Natrox™ ODS will be applied to the subject's diabetic ulcer and attached to the active Natrox™ Oxygen Generator using the tubing provided or regular dressing will be used. The Natrox™ oxygen delivery system (ODS) is a device designed to overcome a number of problems associated with previous methods of oxygen therapy by delivering continuous oxygen to the ulcer bed through a dressing.
No Intervention: Control group

All subjects in this group will receive the Diabetic foot ulcer standards of care which include:

  • Full medical assessment in all cases.
  • Surgical operation/Intervention where indicated.
  • Local treatment of the ulcer (debridement followed by ulcer care according to "modern ulcer healing" standards and management of diabetes.) The ulcer will be photographed at biweekly intervals for a period of 8 weeks to analyze ulcer surface area using a standardized digital imaging software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative change in ulcer surface area
Time Frame: 8 weeks
Comparative change in ulcer surface area in the study group undergoing treatment with the NatroxTM ODS (n=10) after the 8 week treatment period. These changes in ulcer surface area will be compared to the changes measured in the control study group.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

November 5, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Estimate)

November 9, 2015

Last Update Submitted That Met QC Criteria

November 5, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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