References
Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial
Abstract
Objectives:
Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks).
Method:
This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events.
Results:
For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events.
Conclusion:
This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.
Recent literature recognises the increased numbers of patients presenting with complications associated with diabetes, such that diabetic foot disease is now considered the tenth leading cause of global disease burden and disability.1 Many of these wounds are complex hard-to-heal wounds that take extended periods of time to heal despite specialist care in multidisciplinary settings, and the management of such wounds presents clinicians with a challenge from both the clinical and cost-effectiveness perspectives.2 In this context, it is understandable that clinicians are looking for innovations in wound healing to support their patients, particularly those with hard-to-heal wounds.
Due to its key role in facilitating all stages of the wound healing process, from haemostasis through to re-epithelialisation, the use of oxygen in wound healing is not new, and can be traced back to the 1960s, with early work focusing on the role of hyperbaric oxygen.3 It is only recently that there have been enough studies in the field of topical oxygen therapy (TOT) that a systematic review of the evidence could be undertaken. A systematic review, focusing on diabetic foot ulcers (DFUs), included five studies (with a total of 80 patients) of which only two were randomised clinical trials.4 The authors of the review concluded that TOT facilitates wound healing, particularly in less serious ulcers. As Vas and Pananas5 highlighted in their editorial, the scope of this review excluded some other relevant studies. Driver et al.,6 in a study of 130 patients, found no difference in the healing rates for patients receiving standard care (SOC) with or without TOT, while two studies have shown positive results in favour of TOT. Niederauer et al.,7 in a study of 146 patients, demonstrated a two-fold improved rate of healing at 12 weeks when using continuously diffused TOT. Frykberg et al.8 concluded that multimodal TOT applied with pressure, varied cyclically, can lead to even higher healing rates.
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