Randomized Controlled Trial of Topical Hyperbaric Oxygen for Treatment of Diabetic Foot Ulcers

Abstract

The effect of 2 wk of topical hyperbaric oxygen (THO) treatment on the healing of diabetic foot ulcers without associated gangrene was evaluated in a prospective, controlled, and randomized manner in 28 patients. There were 12 patients in the THO group (group 1) and 16 in the control group (group 2). Clinical management of the two patient groups was similar except for THO treatment in the group 1 patients. Clinical parameters, including age, sex, baseline fasting serum glucose levels, duration of diabetes mellitus, duration of foot ulcers, presence of peripheral neuropathy or arterial insufficiency, and evidence of osteomyelitis as determined by radiographs and/or radionuclide scans, were comparable in both groups of patients. No statistical differences (Student's t test) were seen in the number of microorganisms isolated from curettage cultures of the base of the ulcer at days 0, 7, and 14 of the study between groups 1 and 2. In contrast to previous studies, there was a paucity of anaerobic microorganisms isolated from these foot ulcers without associated gangrenous changes. Ulcer areas were estimated by multiplying the maximum width by the maximum length in millimeters at days 0, 7, and 14. Analysis of variance and Student's t test revealed progressive significant reductions in the ulcer areas in both groups when days 0, 7, and 14 were compared and in ulcer depths in both groups when days 0 and 14 were compared. However, such ulcer size changes did not differ statistically between the control and THO groups. A trend toward slower healing was observed in the THO group. Healing of diabetic foot ulcers was not accelerated by THO in this study.

Topical Wound Oxygen Versus Conventional Compression Dressings in the Management of Refractory Venous Ulcers

“…The application of positive pressure oxygen to manage open wounds has been studied extensively and has demonstrated promising clinical results [20][21][22][23][24][25][26][27][28]. The systemic complications associated with the use of a full-body hyperbaric chamber have been overcome by the application of topical wound pure oxygen at an appropriate cycled pressure to only the specific wound site.…”

Topical Oxygen for Chronic Wounds: A PRO/CON Debate

“…39 Leslie et al, in a randomized controlled study showed that patients receiving TOT (n 5 12) displayed a longer healing duration as opposed to patients who received standard care alone (n 5 16). 28 In this study TOT was administered to patients with DFUs in two daily 90-min sessions through a leg chamber that provided humidified 100% oxygen at pressures cycled between 0 and 30 mm Hg (i.e., up to 1.04 atm abs) every 20 s. At day 14 wound size was significantly reduced in all patients, irrespective of which group they were assigned to (p . 0, 05).…”

“…TOT opponents frequently cite a randomized controlled study conducted by Leslie et al as a clear evidence that TOT is not effective. 28 This study, however, has serious methodological flaws. The most significant of these is that, although TOT does not penetrate to bone, a substantial rate of patients with findings suggestive of osteomyelitis were included in the study [6 (50%) of the patients receiving TOT had abnormal bone scans or x rays and above 70 mm/h sedimentation rate].…”

A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes

“…One was randomized and reported no apparent reduction in the cross-sectional area of ulcers at either 7 or 14 days [33]. The other was only partially randomized but reported an apparent benefit at 4 weeks [34].…”