Hyperbaric Oxygen in Diabetic Gangrene Treatment

Baroni, Giancarlo; Porro, Tommaso; Faglia, Ezio; Pizzi, Gianluigi; Mastropasqua, Arturo; Oriani, G; Pedesini, G; Favales, Favales

doi:10.2337/diacare.10.1.81

Cited by 143 publications

(95 citation statements)

References 9 publications

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“…These results are in contrast to several cohort (7,(26)(27)(28)) and open-label randomized trials (5,6,8,9) where no sham placebo was used. The study by Duzgun et al (8), one of the largest trials published, often is quoted as the justification for HBOT utility in treating diabetic wounds (29).…”

Section: Adverse Eventscontrasting

confidence: 84%

“…Defining the most effective treatment strategies is essential to reducing the burden of this disease (1). Hyperbaric oxygen therapy (HBOT) has been used as an adjuvant treatment for difficult-to-heal chronic diabetic foot wounds; however, most evidence for its efficacy is based on observational cohort studies or open-label randomized trials (5)(6)(7)(8)(9). HBOT requires significant patient time and financial commitment compared with conventional wound care without HBOT.…”

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confidence: 99%

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Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

et al. 2016

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OBJECTIVEHyperbaric oxygen therapy (HBOT) is used for the treatment of chronic diabetic foot ulcers (DFUs). The controlled evidence for the efficacy of this treatment is limited. The goal of this study was to assess the efficacy of HBOT in reducing the need for major amputation and improving wound healing in patients with diabetes and chronic DFUs. RESEARCH DESIGN AND METHODSPatients with diabetes and foot lesions (Wagner grade 2-4) of at least 4 weeks' duration participated in this study. In addition to comprehensive wound care, participants were randomly assigned to receive 30 daily sessions of 90 min of HBOT (breathing oxygen at 244 kPa) or sham (breathing air at 125 kPa). Patients, physicians, and researchers were blinded to group assignment. At 12 weeks postrandomization, the primary outcome was freedom from meeting the criteria for amputation as assessed by a vascular surgeon. Secondary outcomes were measures of wound healing. RESULTSOne hundred fifty-seven patients were assessed for eligibility, with 107 randomly assigned and 103 available for end point adjudication. Criteria for major amputation were met in 13 of 54 patients in the sham group and 11 of 49 in the HBOT group (odds ratio 0.91 [95% CI 0.37, 2.28], P = 0.846). Twelve (22%) patients in the sham group and 10 (20%) in the HBOT group were healed (0.90 [0.35, 2.31], P = 0.823). All other indices of wound healing were also not statistically significantly different between groups. CONCLUSIONSHBOT does not offer an additional advantage to comprehensive wound care in reducing the indication for amputation or facilitating wound healing in patients with chronic DFUs.

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Section: Adverse Eventscontrasting

confidence: 84%

mentioning

confidence: 99%

Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

et al. 2016

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“…The apparent faster healing observed in the control group at the end of the study could be explained by the kinetics of the healing process, which begins slowly and then increases (5). In a nonrandomized study, Baroni et al (25) showed that HBO accelerates the healing of diabetic chronic foot ulcer. However, since 18 of the 28 patients were hospitalized, and since 23 had gangrene of the foot and 5 presented neuropathic ulcers, the study population was too heterogenous to draw any reliable conclusions.…”

Section: Discussionmentioning

confidence: 95%

Hyperbaric Oxygenation Accelerates the Healing Rate of Nonischemic Chronic Diabetic Foot Ulcers

Bilbault²,

et al. 2003

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OBJECTIVE -To study the effect of systemic hyperbaric oxygenation (HBO) therapy on the healing course of nonischemic chronic diabetic foot ulcers. RESEARCH DESIGN AND METHODS-From 1999 to 2000, 28 patients (average age 60.2 Ϯ 9.7 years, diabetes duration 18.2 Ϯ 6.6 years), of whom 87% had type 2 diabetes, demonstrating chronic Wagner grades I-III foot ulcers without clinical symptoms of arteriopathy, were studied. They were randomized to undergo HBO because their ulcers did not improve over 3 months of full standard treatment. All the patients demonstrated signs of neuropathy. HBO was applied twice a day, 5 days a week for 2 weeks; each session lasted 90 min at 2.5 ATA (absolute temperature air). The main parameter studied was the size of the foot ulcer measured on tracing graphs with a computer. It was evaluated before HBO and at day 15 and 30 after the baseline.RESULTS -HBO was well tolerated in all but one patient (barotraumatic otitis). The transcutaneous oxygen pressure (TcPO 2 ) measured on the dorsum of the feet of the patients was 45.6 Ϯ 18.1 mmHg (room air). During HBO, the TcPO 2 measured around the ulcer increased significantly from 21.9 Ϯ 12.1 to 454.2 Ϯ 128.1 mmHg (P Ͻ 0.001). At day 15 (i.e., after completion of HBO), the size of ulcers decreased significantly in the HBO group (41.8 Ϯ 25.5 vs. 21.7 Ϯ 16.9% in the control group [P ϭ 0.037]). Such a difference could no longer be observed at day 30 (48.1 Ϯ 30.3 vs. 41.7 Ϯ 27.3%). Four weeks later, complete healing was observed in two patients having undergone HBO and none in the control group.CONCLUSIONS -In addition to standard multidisciplinary management, HBO doubles the mean healing rate of nonischemic chronic foot ulcers in selected diabetic patients. The time dependence of the effect of HBO warrants further investigations. Diabetes Care 26:2378 -2382, 2003L ower-extremity ulcers are responsible for 20% of the hospital admissions of diabetic patients; the incidence of amputation is 6 per 1,000(1). Foot ulcer represents one of the major causes of lower-extremity injuries in the 220 million people suffering from diabetes worldwide, 2.5% of whom will develop a foot ulcer each year (2). Moreover, duration of hospitalization attests to the high morbidity of this condition (3), which has been shown to require as long as ϳ26 weeks for full recovery (4) despite a multidisciplinary approach (associating glycemia control, daily local care, foot offloading antibiotic therapy, and surgical revascularization).The diabetic foot is characterized by sensory, motor, and autonomic neuropathies leading to alteration of pressure distribution, foot deformities, and ulcerations. Metabolic control and infection treatments are of primary importance to control the evolution of the diabetic foot. Hyperbaric oxygenation (HBO) has previously been proposed as an adjunctive treatment for the diabetic foot because it improves in vitro the complex processes underlying healing (5-7). It has also been reported that HBO reduces the incidence of major amputation in diabetic patient...

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“…Given the substantial cost associated with these treatments, a more thorough analysis of human studies dealing with HBO therapy for the diabetic foot is not only justified but necessary. As previously indicated, more than half of the published research reports dealing with HBO therapy for diabetic foot disease originated from a group of researchers at the Center of Diabetology and Metabolic Diseases, Niguarda Hospital, and the Department of Anesthesia and Hyperbaric Medicine, Galeassi Institute, Milan, Italy (8,9,13,14). The first report published by this group appeared in Diabetes Care in 1987 (9).…”

Section: Systemic Hbo Therapymentioning

confidence: 99%

“…The controlled diabetic foot studies included an average of 28 subjects in the HBO therapy group (range 10-62) and 16.2 subjects in the non-HBO control group (range 5-33). Interestingly, four of the seven reports involving the diabetic foot were published by the same group of researchers at the University of Milan between 1987 and 1996 (8,9,13,14).…”

Section: Research Design Andmentioning

confidence: 99%

Systemic hyperbaric oxygen therapy: lower-extremity wound healing and the diabetic foot.

Wunderlich¹,

Peters²,

Lavery³

2000

Diabetes Care

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Systemic Hyperbaric Oxygen TherapyLower-extremity wound healing and the diabetic foot R E V I E W A R T I C L EOBJECTIVE -To document peer-reviewed medical publications that have reported on hyperbaric oxygen (HBO) therapy as an adjunct to standard lower-extremity wound care, focusing on publications dealing with the diabetic foot. RESEARCH DESIGN AND METHODS-A review of the medical literature was conducted using MEDLINE. Research articles involving HBO treatment and the diabetic foot were critiqued to identify factors that may have been a source of bias.RESULTS -Of the published reports on human studies, seven involved diabetes-related foot pathology. Five of these studies, two of which were randomized, included a control group that did not receive HBO therapy. The controlled diabetic foot studies included an average of 28 subjects in the HBO therapy group (range 10-62) and an average of 16.2 subjects in the non-HBO control group (range 5-33). Most of the published reports have several potential sources of bias, including, but not limited to, inadequate evaluation of comorbid conditions relevant to wound healing, small sample size, and poor documentation of wound size or severity. Four of the seven reports involving the diabetic foot were published by a group of researchers at the University of Milan between 1987 and 1996.CONCLUSIONS -Additional randomized placebo-controlled clinical trials in large diabetic populations would further lend credence to the presumption that HBO therapy improves clinical outcomes. Given the relatively high cost of this treatment modality, perhaps a more acute awareness of the medical literature would reduce the economic burden that HBO therapy imposes on care providers that are financially at risk. Diabetes R e v i e w s / C o m m e n t a r i e s / P o s i t i o n S t a t e m e n t s 1552DIABETES CARE, VOLUME 23, NUMBER 10, OCTOBER 2000 Systemic HBO therapytiqued to identify factors that may have been a source of bias. These factors included, but were not limited to, lack of a control group, inadequate sample size, insufficient evaluation of comorbid conditions, and poorly defined methods of retrospective analysis.RESULTS -A total of 76 articles were identified that met the inclusion and exclusion criteria. There were 21 studies involving human subjects (2-22) (Table 1), 27 animal or in vitro studies (23-49), and 28 reviews and/or case reports (50-77). Of the studies involving human subjects, 62% (13 of 21 articles) included a control group. Of the published reports of human studies, seven involved diabetes-related foot pathology. Five of these studies, two of which were randomized, included a control group that did not receive HBO therapy. The controlled diabetic foot studies included an average of 28 subjects in the HBO therapy group (range 10-62) and 16.2 subjects in the non-HBO control group (range 5-33). Interestingly, four of the seven reports involving the diabetic foot were published by the same group of researchers at the University of Milan between 1987 and 1996 (8,9,13...

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Hyperbaric Oxygen in Diabetic Gangrene Treatment

Cited by 143 publications

References 9 publications

Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

Hyperbaric Oxygenation Accelerates the Healing Rate of Nonischemic Chronic Diabetic Foot Ulcers

Systemic hyperbaric oxygen therapy: lower-extremity wound healing and the diabetic foot.

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