NCT02599805

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 9, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

August 13, 2015

Last Update Submit

November 5, 2015

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Study Arms (2)

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.

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.

Interventions

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.

Natrox treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Public Health Agency of Canada. Unpublished analysis using 2000 data from the Economic Burden of Illness in Canada. (Public Health Agency of Canada); 2009.

    BACKGROUND

  • 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

    BACKGROUND

  • 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

Central Study Contacts

Janelle Yu, Bsc

CONTACT

4167971536janelle.yu@mail.utoronto.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2015

First Posted

November 9, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 9, 2015

Record last verified: 2015-11