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Effect of hyperbaric oxygen on cardiac neural regulation in diabetic individuals with foot complications. Diabet Med. 2006 Apr;23(4):360-6
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Abstract Aims There are relatively few effective methods to treat autonomic neuropathy in patients with diabetes mellitus. Our aim was to test the hypothesis that hyperbaric oxygen therapy may restore cardiac neural regulation dysfunction in diabetic individuals with foot complications. Methods We conducted a prospective randomized controlled study in patients with diabetic foot problems. Daily heart-rate variability analysis from 5-min electrocardiography was used to evaluate the temporal change of cardiac neural regulation. The experimental group consisted of 23 subjects exposed to hyperbaric oxygen therapy of 202.65 kPa for 90 min every Monday to Friday for 4 weeks (20 treatments). The control group consisted of 15 age-, sex- and disease-matched subjects who were not exposed to hyperbaric therapy. Patients with medical complications and failure of wound healing were excluded to eliminate possible confounding effects. Results There was no significant difference in baseline R-R interval (RR), variance, high-frequency power (HF), low-frequency power (LF), and LF/HF ratio between the two groups. In the hyperbaric oxygen group there were significant increases in changes of RR (82.7 +/- 16.02 ms); variance 0.88 +/- 0.12 ln(ms(2)); HF 1.06 +/- 0.18 ln(ms(2)); and LF 0.87 +/- 0.15 ln(ms(2)) after the treatment. Measurements of tissue oxygen demonstrated significant increases in local tissue oxygenation in the hyperbaric oxygen group (53.0 +/- 2.6 mmHg) compared with the control group (27.5 +/- 3.1 mmHg), P < 0.05. Conclusion Hyperbaric oxygen therapy has a significant vagotonic effect, which is beneficial in improving cardiac neural regulation in patients with diabetic autonomic dysfunction
Background. Diabetic foot ulceration is common, affecting 1.0%-4.1% of diabetic persons per year and up to 25% in a lifetime. Diabetic foot ulcers are multifactorial in origin, and many are slow to heal and/or are complicated by infection, frequently leading to amputation. Hyperbaric oxygen therapy has been suggested for numerous indications, and it is recognized by funding agencies for a smaller number including diabetic foot wounds.Methods. I reviewed the literature about the history and practice of hyperbaric oxygen therapy and key issues relevant to efficacy, effectiveness, and cost-effectiveness.Results. Although recognized for reimbursement by Medicare and major insurers, the evidence base for hyperbaric oxygen therapy for diabetic foot care remains weak. A systematic review for the Cochrane Collaboration concluded that hyperbaric oxygen therapy may have value in treating diabetic wounds, but the studies reviewed all had methodological weaknesses, and the positive effect of treatment was not seen in the single reviewed randomized trial to include a sham treatment arm. Hyperbaric oxygen therapy consumes very substantial resources--and has the potential to consume far more--that could be better spent on other aspects of management or prevention of diabetic foot ulceration.Conclusions. Hyperbaric oxygen therapy should not be offered for diabetic foot wounds until large-scale, adequately blinded, controlled, and powered randomized studies have clearly demonstrated efficacy and cost effectiveness in the healing of ulcers and the prevention of major amputation.
Effects of hyperbaric oxygen therapy on circulating interleukin-8, nitric oxide, and insulin-like growth factors in patients with type 2 diabetes mellitus. Clin Biochem. 2006 Aug 14;
Chen SJ, Yu CT, Cheng YL, Yu SY, Lo HC
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BACKGROUND:: The potential benefits of hyperbaric oxygen therapy (HBOT) have been reported in diabetic patients with foot ulcers. However, the roles of HBOT on wound healing-associated growth factors and inflammatory mediators are not completely understood in diabetes mellitus (DM).
OBJECTIVES:: The aim of this study was to investigate the effects of HBOT on circulating cytokines, NO, and insulin-like growth factors (IGF) in patients with type 2 DM.
DESIGN AND METHODS:: Serum samples were collected from patients with type 2 DM (n=31) and healthy subjects (n=29) before (baseline) and after the first and third exposure.
RESULTS:: Before HBOT, body mass index (BMI) and serum HbA1c were significantly greater, whereas serum IGF-I was significantly lower in diabetic patients compared to healthy subjects (one-way ANOVA, p<0.05). After adjusting for age, gender, and BMI, serum insulin, growth hormone (GH), IGF-II, IGF-binding protein (IGFBP)-1, IGFBP-3, leptin, interleukin (IL)-8, and NO were not significantly altered by HBOT in diabetic patients and healthy subjects (repeated-measures ANOVA). Change in serum insulin (baseline to the third exposure) was a positive predictor of changes in leptin and NO in healthy subjects and diabetic patients, respectively.
CONCLUSIONS:: Our results suggest that short-term HBOT may not alter the circulating insulin, IGF, leptin, IL-8, and NO levels. In addition, healthy subjects and diabetic patients showed differential responses to HBOT in the relationships of leptin, insulin, and NO. Further studies are needed to clarify the mechanism of HBOT-improved wound healing in diabetic patients with foot ulcers.
Early and late effects of hyperbaric oxygen treatment on oxidative stress parameters in diabetic patients. Physiol Res. 2007 Jan 2;
Gürdöl F, Cimşit M, Oner-Iyidogan Y, Körpinar S, Yalçinkaya S, Koçak H
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Exposure to hyperbaric oxygen leads to increases in the amount of reactive oxygen species (ROS) that are derived from a variety of sources. After the discovery that ROS can function as signalling molecules, the idea of ROS being hazardous to biological tissues has been challenged. The aim of this study was to examine the changes in oxidative stress parameters in diabetics undergoing hyperbaric oxygen therapy (HBOT) due to foot ulcers. Twenty patients who received HBOT for diabetic foot ulcers were included in the study. Blood samples were taken before HBOT and 30 min after the exit from the chamber, on the day of the first and 15th HBO sessions, and used for the determinations of malondialdehyde (MDA), 8-isoprostane and advanced oxidation protein products (AOPPs). Statistical evaluations were made by the two-way ANOVA. 8-Isoprostane and AOPP levels did not alter significantly after the first HBO therapy, while both were increased on the fifteenth day (p<0.05). MDA was significantly increased only after the first HBOT, and remained unchanged on the fifteenth day. Plasma AOPP levels lowered significantly after fifteen consecutive HBOT. Decreased AOPP levels suggest that increased oxygenation of tissues due to HBO therapy may activate some endogenous factors that prevent hazardous effects of the disease itself.
Factors influencing the outcome of lower-extremity diabetic ulcers treated with hyperbaric oxygen therapy.
Fife CE, Buyukcakir C, Otto G, Sheffield P, Love T, Warriner R Wound Repair Regen. 2007 May-Jun;15(3):322-31.
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The objectives of this study were to report outcomes of a large number of patients receiving hyperbaric oxygen therapy (HBO(2)T) for diabetic lower-extremity ulcers, and to identify likely outcome predictors. Five hyperbaric facilities supplied data on 1,006 patients. A sixth clinic served as a validation sample for the regression-based prediction model, and later additional data from Memorial Hermann Hospital were added. The severity of lower-extremity lesions was assessed upon initiation of HBO(2)T using the Modified Wagner scale, and the outcome described as healed, partially healed, not improved, amputated, or died. Overall, 73.8% of patients improved (granulated or healed). Factors significantly related to outcome included renal failure, pack-year smoking history, transcutaneous oximetry, number of HBO(2)T treatments, and interruption of treatment regimen. Number of treatments per week and treatment pressure (2.0 vs. 2.4 atmospheres absolute) were not significant factors in outcome. Concomitant administration of autologous growth factor gel did not improve outcome. A multiple regression model was fitted to the data that can be used to predict the outcome of diabetic patients undergoing HBO(2)T. Given the high cost of amputation and rehabilitation, these data suggest that hyperbaric oxygen treatment should be an important adjunctive therapy to heal lower-extremity lesions, especially those with a Wagner grade of 3 or higher.
The clinical and economic potential of hyperbaric oxygen therapy in the treatment of diabetic ulceration and other conditions.
McMillan G, Glover M. Int J Low Extrem Wounds. 2007 Sep;6(3):130-8.
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Selective use of systemic hyperbaric oxygen therapy (HBOT) is a treatment that deserves further study and analysis. The current situation in the United Kingdom (UK) is discussed in relation to available evidence and practices elsewhere. It would appear that there is increasing evidence that HBOT could benefit many patients and health care budgets through improved clinical efficacy and cost-efficiency in the treatment of specific conditions, notably nonhealing diabetic ulceration of the lower limbs. This is not only disabling, it may lead to amputation. It is also a financial burden to patients and health service providers. In the UK, it is estimated that chronic wound care costs more than pound1 billion a year, with diabetic ulceration accounting for a substantial part of that staggering sum. It has been said repeatedly, and quite correctly, that there is insufficient good-quality evidence upon which a properly informed decision may be made on the contribution HBOT might make to alleviate that situation. It is intriguing that no determined effort is apparent that would seek to settle the issue by encouraging and facilitating appropriately designed and conducted randomized controlled trials to assess the actual effects of this treatment. Indeed, a proposed government research initiative appears to have been cancelled. Is lack of research preventing provision of HBOT?
Introduction: Hyperbaric oxygen therapy (HBOT) involves the inhalation of 100 percent oxygen at pressures greater than at sea level. One of the most common indications for HBOT is to aid healing of diabetic foot wounds. Methods: All cases of diabetic foot wounds that were seen by the Hyperbaric Medicine Centre in Tan Tock Seng Hospital from May 2005 to March 2006 were analysed in terms of outcome (wound healing) after HBOT. Results: A total of 45 cases of foot ulcers/wounds were analysed. 32 patients had a favourable outcome, giving a success rate of 71 percent. The remaining 13 (28 percent) did not have a favourable outcome to HBOT. The success rate was even more significant as a large number of these patients (34 [77 percent]) were told by their specialist that they were at high risk of a further amputation. No major complications were noted. Conclusion: The experience of the Hyperbaric Medicine Centre in Singapore is consistent with that reported in other centres. With proper patient selection, HBOT, together with a multidisciplinary team of vascular and orthopaedic surgeons, podiatrists, infection disease physicians and endocrinologists, can help reduce the numbers and severity of amputations as well as downtime due to increased wound healing.
Background: Hyperbaric oxygen therapy (HBOT) has been proposed as an adjunct to standard methods of care for diabetic foot ulcers (DFU). Its use may decrease the risk of infection and lower extremity amputations (LEAs). As part of a Canadian assessment, we estimated the cost-effectiveness and budget impact of HBOT in this application.
Methods: We developed a decision model comparing adjunctive HBOT with standard care alone. The population was a 65-year-old cohort with DFU. The time horizon was 12 years taken from a Ministry of Health perspective. The health states were a healed wound with or without a minor LEA, an unhealed wound with no related surgery, and a major LEA. Efficacy data were based on outcomes reported in studies included in a literature review. Cost and capacity needs for treating DFU patients in Canada were estimated using prevalence data from the literature, and cost and utilization data from government records.
Results: The 12-year cost for patients receiving HBOT was CND$40,695 compared with CND$49,786 for standard care alone. Outcomes were 3.64 quality-adjusted life-years (QALYs) for those receiving HBOT and 3.01 QALYs for controls. Estimated cost to treat all prevalent DFU cases in Canada was CND$14.4-19.7 million/year over 4 years. If seven-person HBOT chambers were used, a further nineteen to thirty-five machines would be required nationally.
Conclusions: Adjunctive HBOT for DFU is cost-effective compared with standard care. Additional HBOT capacity would be needed if it were to be adopted as the standard of care throughout Canada.
Can major amputation rates be decreased in diabetic foot ulcers with hyperbaric oxygen therapy?
Kaya A, Aydin F, Altay T, Karapinar L, Ozturk H, Karakuzu C. Int Orthop. 2008 Jul 25. [Epub ahead of print]
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Although hyperbaric oxygen therapy has been used for diabetic foot ulcer since the 1980s, there is little information on its efficacy. The aim of this study is to evaluate whether hyperbaric oxygen can decrease major amputation rates and to determine the predictive factors. A total of 184 consecutive patients were treated with hyperbaric oxygen therapy as an adjunct to standard treatment modalities for their diabetic foot ulcer. Of these patients, 115 were completely healed, 31 showed no improvement and 38 underwent amputation. Of the amputations, nine (4.9%) were major amputations (below knee) and 29 were minor. Major amputations were associated with the Wagner grade (p < 0.0001), with the age of the patients (p = 0.028) and with the age of the wounds (p = 0.018). Hyperbaric oxygen therapy can help to reduce the major amputation rates in diabetic foot ulcer. However, further large, multicentre, randomised controlled studies are needed to make more accurate conclusions.
Hyperbaric oxygen therapy can be used as an adjunct to standard wound care in the treatment of diabetic patients with foot ulcers. We undertook a prospective, randomized investigation of the use of hyperbaric oxygen therapy versus standard therapy for the treatment of foot ulcers in diabetic patients. A number of demographic variables were analyzed in regard to wound healing. We noted that foot ulcers in patients in the hyperbaric oxygen therapy group were more likely to heal, and were more likely to undergo amputation distal to the metatarsophalangeal joint compared with those patients receiving standard therapy without hyperbaric oxygen. We feel that hyperbaric oxygen therapy should be considered a useful adjunct in the management of foot ulcers in diabetic patients
Hyperbaric oxygen, oxidative stress, NO bioavailability and ulcer oxygenation in diabetic patients.
Efrati S, Gall N, Bergan J, Fishlev G, Bass A, Berman S, Hamad-Abu R, Feigenzon M, Weissgarten J. Undersea Hyperb Med. 2009 Jan-Feb;36(1):1-12.
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BACKGROUND: Hyperbaric oxygen therapy (HBO2) increases tissue oxygenation, thus serving as an adjunct therapy for diabetic wounds. However, in some patients there is insufficient increase in tissue O2.
AIMS: To investigate the pathophysiology of insufficient HBO2 and the possible role of N-acetylcysteine (NAC).
METHODS: Prospective, randomized, cross-over trial included 50 diabetic patients with non-healing ulcers. Each patient received two treatments with 100% oxygen/2ATA. NAC was administered i.v. at one of the two treatments. Basal and post-treatment peri-wound transcutaneous O2 (TcPO2) pressure, malondialdehyde (MDA), total anti-oxidant status (TAOS) and nitric oxide (NO) were assessed. An ulcer oxygenation increase above 200 mmHg was accepted as sufficient.
RESULTS: During HBO2, 17 patients (34%) demonstrated insufficient increase in TcPO2. Concomitantly, their TAOS and NO decreased, while MDA increased. NAC administration attenuated these parameters, thus improving the HBO2 outcome. In those affected by NAC, the cure rate was 75%. By contrast, in 66% of patients with sufficient increase in TcPO2 TAOS was increased and MDA decreased irrespective of NAC administration. The cure rate in this subgroup was 82%.
CONCLUSIONS: Insufficient increase of ulcer oxygenation during HBO2 results from exaggerated oxidative stress and decreased NO bioavailability. NAC administration-induced modulation of both parameters and may improve ulcer oxygenation during HBO2.
Hyperbaric oxygen therapy for wound healing and limb salvage: a systematic review.
Goldman RJ. PM R. 2009 May;1(5):471-89.
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This article is a systematic review evaluating published clinical evidence of the efficacy of hyperbaric oxygen therapy (HBOT) for wound healing and limb salvage. The data source is the Ovid/Medline database for key word "Hyperbaric Oxygenation" with search limits (human studies, 1978-2008). Results were combined by Boolean AND with 1 of the 3 following searches: (a) wound healing (10 permutations); (b) compromised flap or graft (3); and (c) osteomyelitis (1). The author evaluated 620 citations, of which 64 reported original observational studies and randomized controlled trials (RCTs) on HBOT and healing outcomes. All citations with 5 subjects were selected for full text review (44 articles) and evaluated according to GRADE criteria for high, medium, low, or very low level of evidence. A Cochrane review identified 1 additional study with a low level of evidence. This systematic review discusses and tabulates every article of high or moderate level of evidence. For patients with diabetic foot ulcers (DFU) complicated by surgical infection, HBOT reduces chance of amputation (odds ratio [OR] 0.242, 95% CI: 0.137-0.428) (7 studies) and improves chance of healing (OR 9.992, 95% CI: 3.972-25.132) (6 studies). Positive efficacy corresponds to HBOT-induced hyperoxygenation of at-risk tissue (7 studies) as measured by transcutaneous oximetry. HBOT is associated with remission of about 85% of cases of refractory lower extremity osteomyelitis, but an RCT is lacking to clarify extent of effect. There is a high level of evidence that HBOT reduces risk of amputation in the DFU population by promoting partial and full healing of problem wounds. There is a moderate level of evidence that HBOT promotes healing of arterial ulcers, calciphylactic and refractory vasculitic ulcers, as well as refractory osteomyelitis. There is a low to moderate level of evidence that HBOT promotes successful "take" of compromised flaps and grafts.
Diabetic persons with foot ulcers and their perceptions of hyperbaric oxygen chamber therapy.
Katarina H, Magnus L, Per K, Jan A. J Clin Nurs. 2009 Jul;18(14):1975-85.
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AIM: To elucidate how diabetic patients with limb-threatening foot lesions perceive and evaluate content and organisation of treatment in a multi-place hyperbaric oxygen chamber.
BACKGROUND: To our knowledge there are no patients' evaluations of diabetes care in a high-technology area like the hyperbaric oxygen chamber. The burden on persons with diabetic foot complications might be increased if adjuvant therapy with hyperbaric oxygen therapy (HBOT) within a locked airtight vessel is given.
DESIGN: Explorative study. PARTICIPANTS: Participants were included in the HODFU study, a prospective randomised double-blind study, designed to evaluate whether HBOT heals more chronic foot ulcers than placebo treatment with hyperbaric air. Six females and 13 males, aged 44-83 years (median 70), with diabetic foot ulcers, participated. METHOD: Focus-group interviews by an external evaluator.
RESULTS: Management was perceived as well-functioning with competent staff delivering quick treatment in a positive manner and in good co-operation. HBOT sessions, in groups, were described as unproblematic and pleasant, through sharing experiences with others, although time-consuming and tiring. Recognising the responsible physician and communication with other physicians in the health-care chain was perceived as problematic. Placebo treatment, when given, did not reveal any problems; many perceived HBOT as the last resort and respondents had a negative view of future health and expressed fears of new wounds and amputation.
CONCLUSIONS AND RELEVANCE TO CLINICAL PRACTICE: From patients' perspective HBOT in the delivered health-care model was perceived as well-functioning, taking into consideration both technical and relational aspects of care in this high-technology environment. Communication with the patient and between different care givers, with a consistent message given and information about who is responsible and to whom one should turn, wherever treated, is the most crucial aspect of the model. Future fears need to be recognised and group interaction can be encouraged to share the burden of disease
A three species model to simulate application of Hyperbaric Oxygen Therapy to chronic wounds.
Flegg JA, McElwain DL, Byrne HM, Turner IW. PLoS Comput Biol. 2009 Jul;5(7):e100045
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Chronic wounds are a significant socioeconomic problem for governments worldwide. Approximately 15% of people who suffer from diabetes will experience a lower-limb ulcer at some stage of their lives, and 24% of these wounds will ultimately result in amputation of the lower limb. Hyperbaric Oxygen Therapy (HBOT) has been shown to aid the healing of chronic wounds; however, the causal reasons for the improved healing remain unclear and hence current HBOT protocols remain empirical. Here we develop a three-species mathematical model of wound healing that is used to simulate the application of hyperbaric oxygen therapy in the treatment of wounds. Based on our modelling, we predict that intermittent HBOT will assist chronic wound healing while normobaric oxygen is ineffective in treating such wounds. Furthermore, treatment should continue until healing is complete, and HBOT will not stimulate healing under all circumstances, leading us to conclude that finding the right protocol for an individual patient is crucial if HBOT is to be effective. We provide constraints that depend on the model parameters for the range of HBOT protocols that will stimulate healing. More specifically, we predict that patients with a poor arterial supply of oxygen, high consumption of oxygen by the wound tissue, chronically hypoxic wounds, and/or a dysfunctional endothelial cell response to oxygen are at risk of nonresponsiveness to HBOT. The work of this paper can, in some way, highlight which patients are most likely to respond well to HBOT (for example, those with a good arterial supply), and thus has the potential to assist in improving both the success rate and hence the cost-effectiveness of this therapy.
Hyperbaric oxygen and diabetic foot ulcers
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