Diabetic Foot Clinical Trial
Official title:
Can Topical Oxygen Therapy (Natrox™) Improve Wound Healing in Diabetic Foot Ulcers?
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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