Evaluation of Effects of Continuous Topical Oxygen Therapy on Diabetic Foot Ulcers

Introduction:
Diabetic foot ulcers represent a significant burden of disease for diabetic patients, having implications for quality of life, risk of infection/amputation, and health care expenses. The healing of diabetic foot ulcers is of particular concern for wound care physicians in an effort to mitigate the aforementioned complications. Topical oxygen therapy is intended to overcome wound healing deficits secondary to a paucity of normal oxygen tension in the wound bed. This study evaluates the healing of DFUs after the placement of a topical oxygen therapy dressing.

Methods:
This prospective single arm, open label, single institution historic comparative quality assessment enrolled patients with non-healing or difficult to heal diabetic foot ulcers, potentially recently treated with cellular and tissue based products. After enrollment the patient had the topical oxygen device placed for a treatment period of 8 weeks. Primary endpoints were tolerance of the product and any clinical evidence of wound infection. Secondary endpoints included percentage wound closure, compliance, and reporting of any adverse events.

Results:

Patients were enrolled and had placement of the topical oxygen device in their respective wound beds for 8 weeks of treatment. One patient un-enrolled from the study due to non-compliance and desire to pursue alternative healing therapies. Patients all had wound sizes measured on follow-up visits with consistent decrease in wound size. Dressing changes were performed weekly. No new infections or adverse events were reported.

Conclusion:
As one potential option for wound healing devices for diabetic foot ulcers, topical oxygen therapy was well tolerated by our patient population and demonstrated improved wound healing consistently. Further studies are appropriate for the evaluation of long term results.

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