Diabetic FootPhase 3NCT02599805
Can Topical Oxygen Therapy (Natrox™) Improve Wound Healing in Diabetic Foot Ulcers?
A Phase 3 study testing Natrox™ Oxygen Delivery System (ODS) in people with Diabetic Foot, run by Unity Health Toronto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Natrox™ Oxygen Delivery System (ODS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Diabetic Foot
- Being tested
- Natrox™ Oxygen Delivery System (ODS)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natrox™ Oxygen Delivery System (ODS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Natrox treatment group | Experimental | 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. Receives: Device: Natrox™ Oxygen Delivery System (ODS) |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599805
- Sponsor's protocol ID
- tba
- Status last verified
- Nov 2015
- First submitted
- 13 Aug 2015
- Last updated
- 9 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Public Health Agency of Canada. Unpublished analysis using 2000 data from the Economic Burden of Illness in Canada. (Public Health Agency of Canada); 2009.
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
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.
PubMed 24201169
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Topical Oxygen Therapy (Natrox™) Improve Wound Healing in Diabetic Foot Ulcers?
- ClinicalTrials.gov ID
- NCT02599805
- Acronym / sponsor ID
- tba
- Conditions
- Diabetic Foot
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natrox treatment group | Experimental | Device: Natrox™ Oxygen Delivery System (ODS)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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Natrox treatment group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2015.
- BackgroundPublic Health Agency of Canada. Unpublished analysis using 2000 data from the Economic Burden of Illness in Canada. (Public Health Agency of Canada); 2009.
- BackgroundMani 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
- Background: PubMed 24201169Driver 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.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Natrox™ Oxygen Delivery System (ODS) in people with Diabetic Foot, run by Unity Health Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janelle Yu, Bsc (4167971536, janelle.yu@mail.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative change in ulcer surface area (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02599805, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2015.