Back to resultsCan Topical Oxygen Therapy (Natrox™) Improve Wound Healing in Diabetic Foot Ulcers?
Primary Purpose
Diabetic Foot
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Natrox™ Oxygen Delivery System (ODS)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot
Eligibility Criteria
Inclusion Criteria
- Diabetic foot ulcer, which has had optimum multi-disciplinary team management for >4 weeks
- No planned treatment to arterial disease
- No planned surgical intervention
- Patients aged >18 years.
- Patients who understand the study, agree to adhere to the treatment and are able to give consent
- Patients who can be followed by the same investigating team for the whole period of their participation in the study
Exclusion Criteria
- Presence of invasive infection requiring intravenous antibiotics
- Presence of Methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aureus in the swab cultures
- Pure Neuropathic ulcer with no arterial insufficiency unless they fail to heal within 12 weeks of optimum management
- Significant reduced immunity or high dose corticosteroids (>10mg Prednisolone) or other second line immune-suppressant
- Need for total contact cast
- Patients with a known sensitivity to any of the components of the evaluation device
- Patients with known or suspected malignancy in the ulcer or surrounding tissue.
- 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
- Patients who present with more than 10% of the ulcer surface area covered in hard eschar
- Patients with ulcer surface area of more than 10x10cm
- Patients who are participating in another clinical study for ulcer management
- Patients with a known history of poor compliance with medical treatment
- Patients who are unable to understand the aims of the study and not give informed consent
- Pregnant female patient.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Natrox treatment group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Comparative change in ulcer surface area
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02599805
Brief Title
Can Topical Oxygen Therapy (Natrox™) Improve Wound Healing in Diabetic Foot Ulcers?
Official Title
Can Topical Oxygen Therapy (Natrox™) Improve Wound Healing in Diabetic Foot Ulcers?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Natrox treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Natrox™ Oxygen Delivery System (ODS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparative change in ulcer surface area
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Diabetic foot ulcer, which has had optimum multi-disciplinary team management for >4 weeks
No planned treatment to arterial disease
No planned surgical intervention
Patients aged >18 years.
Patients who understand the study, agree to adhere to the treatment and are able to give consent
Patients who can be followed by the same investigating team for the whole period of their participation in the study
Exclusion Criteria
Presence of invasive infection requiring intravenous antibiotics
Presence of Methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aureus in the swab cultures
Pure Neuropathic ulcer with no arterial insufficiency unless they fail to heal within 12 weeks of optimum management
Significant reduced immunity or high dose corticosteroids (>10mg Prednisolone) or other second line immune-suppressant
Need for total contact cast
Patients with a known sensitivity to any of the components of the evaluation device
Patients with known or suspected malignancy in the ulcer or surrounding tissue.
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
Patients who present with more than 10% of the ulcer surface area covered in hard eschar
Patients with ulcer surface area of more than 10x10cm
Patients who are participating in another clinical study for ulcer management
Patients with a known history of poor compliance with medical treatment
Patients who are unable to understand the aims of the study and not give informed consent
Pregnant female patient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janelle Yu, Bsc
Phone
4167971536
Email
janelle.yu@mail.utoronto.ca
12. IPD Sharing Statement
Citations:
Citation
Public Health Agency of Canada. Unpublished analysis using 2000 data from the Economic Burden of Illness in Canada. (Public Health Agency of Canada); 2009.
Results Reference
background
Citation
Mani R (2010) Topical oxygen therapy for chronic wounds: a report on the potential of Inotec® a new device for delivering enriched oxygen to chronic wounds
Results Reference
background
PubMed Identifier
24201169
Citation
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.
Results Reference
background
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Can Topical Oxygen Therapy (Natrox™) Improve Wound Healing in Diabetic Foot Ulcers?
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