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Diabetic foot ulcers treated with hyperbaric oxygen therapy: a review of the literature.
Bishop AJ, Mudge E. Int Wound J. 2012 Jul 2.
Hyperbaric oxygen therapy (HBO) has been used as an adjunct for healing diabetic foot ulcers (DFUs) for decades. However, its use remains controversial. A literature search was conducted to locate clinical studies and assess the available evidence. Ten prospective and seven retrospective studies evaluating HBO for DFUs were located. These were reviewed and the outcomes were discussed. One study reported no difference in outcomes between patients receiving hyperbaric oxygen and the control group. However, their regime differed from all other studies in that patients received hyperbaric oxygen twice rather than once daily. Reduced amputation rates and improved healing were the most common outcomes observed.
Dear Editor, I read with interest Dr Bennett's excellent recent appraisal of the study by Londahl and colleagues.1-4 However, there are some concerns with respect to the trial design that I would like to highlight. Londahl et al's study on the addition of hyperbaric oxygen to specialised wound care for chronic diabetic foot ulcers uses a questionable "sham" treatment method, which has been employed by the same research team previously.5 The paper by Londahl et al was also included in the recently updated Cochrane review of hyperbaric oxygen therapy for chronic wounds and appraised as having a low risk of bias, exclusively owing to the inclusion of a control group.6 What has not been commented on is whether their choice of control (sham) was appropriate. Londahl et al compared the effect of hyperbaric oxygen at 254 kPa in patients with diabetic foot ulcers with a sham group where patients breathed air at 254 kPa. In real terms, therefore, sham was equivalent to breathing 50% O2 under normobaric conditions, which is not a true control. It could be argued that breathing 100% O2 at normobaric pressure may have produced the same differences between the two groups. To better discern the effects of hyperbaric oxygen at 254 kPa a better control group would have been air at 1.0 ATA. Such an approach would confirm beyond doubt that the wound-healing effects are entirely attributable to hyperbaric oxygen. There is also lack of discussion regarding the possible risk of decompression illness (DCI) in the control group since they are exposed to 90 mins of air at 254 kPa. This also raises ethical issues as the 'control' group is being exposed to a risk that the experimental group is not subject to. There were no reports of any adverse effects in the control arm, but the study only analysed 90 patients and the relative risk may be low, but still real. Conducting research in hyperbaric medicine is very difficult because of the problems of delivering sham treatments and Londahl and colleagues have improved substantially on previous published studies. For instance, the study by Annane et al gave hypoxic gas mixtures under pressure to their control group to ensure they received the same oxygen dose equivalent to a patient breathing air at normobaric pressure.7 This was confirmed by blood gas analysis and the control group was therefore not only exposed to a potentially lethal gas mixture if pressurisation failed, but also the dual risks of arterial puncture and decompression sickness. In order to undertake well-designed RCTs in hyperbaric medicine there has to be careful thought given to the appropriate control treatment group/sham, which should carry with it a negligible risk. Hyperbaric research needs to be promoted internationally and intervention trials should be designed with high methodological rigour. I disagree with Dr Bennett's assertion that this trial satisfied that principle.
This article reviews evidence for the promotion of healing using hyperbaric oxygen therapy (HBOT). HBOT is an adjuvant wound therapy that has been suggested to be beneficial for the healing of wounds for over 40 years. Current approved treatments provide 100% oxygen to a patient who is in a multi-place compression chamber accompanied inside the chamber by a trained attendant. Its ability to increase the arterial partial pressure of oxygen in the human body and facilitate oxygen transport when the body's oxygen transport system has been compromised makes it appropriate for a number of indications. Oxygen is essential for normal wound healing and contributes to a number of processes required for a healing wound. HBOT is an additional therapy and lacks the capacity to heal wounds without the application of approved wound care practice. Animal studies and clinical trials have demonstrated the benefits of HBOT on the hypovascular-hypocellular-hypoxic environment of a chronic wound when the wound has not responded to other treatments. Evidence suggests that the addition of HBOT is effective in the healing of diabetic foot ulcers but that presently this benefit is not evident at long-term follow up.
To assess the efficacy and safety of hyperbaric oxygenation (HBO) therapy as adjunctive treatment for diabetic foot ulcers with a systematic review and meta-analysis of the literature.
MEDLINE, EMBASE, and the Cochrane Library were searched to find relevant articles published up to April 20, 2012, without restriction as to language or publication status. All controlled trials that evaluated adjunctive treatment with HBO therapy compared with treatment without HBO for chronic diabetic foot ulcers were selected. A meta-analysis was performed to assess the efficacy and safety of hyperbaric oxygen in managing foot ulcers.
Thirteen trials (a total of 624 patients), including 7 prospective randomized trials, performed between January 1, 1966, and April 20, 2012, were identified as eligible for inclusion in the study. Pooling analysis revealed that, compared with treatment without HBO, adjunctive treatment with HBO resulted in a significantly higher proportion of healed diabetic ulcers (relative risk, 2.33; 95% CI, 1.51-3.60). The analysis also revealed that treatment with HBO was associated with a significant reduction in the risk of major amputations (relative risk, 0.29; 95% CI, 0.19-0.44); however, the rate of minor amputations was not affected (P=.30). Adverse events associated with HBO treatment were rare and reversible and not more frequent than those occurring without HBO treatment (P=.37).
This meta-analysis reveals that treatment with HBO improved the rate of healing and reduced the risk of major amputations in patients with diabetic foot ulcers. On the basis of these effects, we believe that quality of life could be improved in selected patients treated with HBO.
Lack of Effectiveness of Hyperbaric Oxygen Therapy for the Treatment of Diabetic Foot Ulcer and the Prevention of Amputation
A cohort study
David J. Margolis, Jayanta Gupta, Ole Hoffstad, Maryte Papdopoulos, Henry A. Glick, Stephen R. Thom, Nandita Mitra Diabetes Care February 19, 2013
OBJECTIVE Hyperbaric oxygen (HBO) is a device that is used to treat foot ulcers. The study goal was to compare the effectiveness of HBO with other conventional therapies administered in a wound care network for the treatment of a diabetic foot ulcer and prevention of lower extremity amputation.
RESEARCH DESIGN AND METHODS This was a longitudinal observational cohort study. To address treatment selection bias, we used propensity scores to determine the “propensity” that an individual was selected to receive HBO.
RESULTS We studied 6,259 individuals with diabetes, adequate lower limb arterial perfusion, and foot ulcer extending through the dermis, representing 767,060 person-days of wound care. In the propensity score–adjusted models, individuals receiving HBO were less likely have healing of their foot ulcer (hazard ratio, 0.68; 95% confidence interval, 0.63–0.73) and more likely to have an amputation (2.37 [1.84–3.04]). Additional analyses, including the use of an instrumental variable, were conducted to assess the robustness of our results to unmeasured confounding. HBO was not found to improve the likelihood that a wound might heal or to decrease the likelihood of amputation in any of these analyses.
CONCLUSIONS Use of HBO neither improved the likelihood that a wound would heal nor prevented amputation in a cohort of patients defined by Centers for Medicare and Medicaid Services eligibility criteria. The usefulness of HBO in the treatment of diabetic foot ulcers needs to be reevaluated.
A prospective, randomized, controlled study of hyperbaric oxygen therapy: effects on healing and oxidative stress of ulcer tissue in patients with a diabetic foot ulcer.
Ma L, Li P, Shi Z, Hou T, Chen X, Du J. Ostomy Wound Manage. 2013 Mar;59(3):18-24.
Although hyperbaric oxygen (HBO) therapy has been reported to help heal chronic foot ulcers in patients with diabetes mellitus (DM), production of HBO-related oxidative stress is a concern. To assess the therapeutic effect and oxidative stress of HBO, a 2-week, prospective, randomized, controlled clinical study was conducted from January 1, 2010 to January1, 2012 among 36 consecutively admitted patients with diabetic foot ulcers (DFU). Average patient age was 60.08 ± 5.97 years and average DM duration was 16.4 ± 11.3 years; 86.1% had type 2 DM, and 47.2% had Wagner grade-III foot ulcers. Patients randomized to the control group (n = 18) received standard care including offloading, wound debridement, and glucose control. HBO treatment group patients (n = 18) received standard care and twice-daily HBO sessions for 90 minutes at 2.5 atmospheres absolute (ATA) 5 days a week for 2 weeks. Transcutaneous oxygen pressure (TcPo2) at the edge of the ulcer and wound size were measured at baseline and after 7 and 14 days of treatment. Ulcer tissues were harvested on days 7 and 14 to determine oxidative stress by measuring malondialdehyde (MDA) and antioxidant enzyme (superoxide dismutase [SOD], catalase [CAT], and glutathione peroxidase [GPx]) levels. Compared to baseline, TcPo2 in the HBO group increased on day 7 (477.8 ± 118.2 mm Hg versus 37.06 ± 5.23 mm Hg, P <0.01) and day 14 (501.1 ± 137.7 mm Hg versus 35.61 ± 4.85 mm Hg, P <0.01). Ulcer size reduction in the HBO group was greater than that of the control group (42.4% ± 20.0% versus 18.1% ± 6.5%, P <0.05). MDA levels, SOD, and CAT were all significantly higher in the HBO than in the control group on day 14 (P<0.05). The results of this study suggest HBO treatment for 2 weeks initiates a healing response in chronic DFUs, but the observed oxidative stress in local ulcer tissue may offset this effect long-term. Until needed additional research has been conducted, prolonged and/or inappropriate HBO treatment should be avoided.