Diabetic Foot - Treatment

Hyperbaric Oxygenation - updated: 15 March 2008

Hyperbaric oxygen therapy for chronic wounds

Cochrane Database Syst Rev. 2004;(2):CD004123

Kranke P, Bennett M, Roeckl-Wiedmann I, Debus S.

BACKGROUND: Chronic wounds are common and present a health problem with significant effect on quality of life. The wide range of therapeutic strategies for such wounds reflects the various pathologies that may cause tissue breakdown, including poor blood supply resulting in inadequate oxygenation of the wound bed. Hyperbaric oxygen therapy (HBOT) has been suggested to improve oxygen supply to wounds and therefore improve their healing. OBJECTIVES: To assess the benefits and harms of adjunctive HBOT for treating chronic ulcers of the lower limb (diabetic foot ulcers, venous and arterial ulcers and pressure ulcers). SEARCH STRATEGY: We searched the Cochrane Wounds Group Specialised Trial Register (searched 6 February 2003), CENTRAL (The Cochrane Library Issue 1, 2003), Medline (1966 - 2003), EMBASE (1974 - 2003), DORCTHIM (1996 - 2003), and reference lists of articles. Relevant journals were handsearched and researchers in the field were contacted. SELECTION CRITERIA: Randomised studies comparing the effect on chronic wound healing of therapeutic regimens which include HBOT with those that exclude HBOT (with or without sham therapy). DATA COLLECTION AND ANALYSIS: Three reviewers independently evaluated the quality of the relevant trials using the validated Oxford-Scale (Jadad 1996) and extracted the data from the included trials. MAIN RESULTS: Five trials contributed to this review. Diabetic foot ulcer (4 trials, 147 patients): Pooled data of three trials with 118 patients showed a reduction in the risk of major amputation when adjunctive HBOT was used, compared to the alternative therapy (RR 0.31, 95% CI 0.13 to 0.71). Sensitivity analysis for the allocation of dropouts did not significantly alter that result. This analysis predicts that we would need to treat 4 individuals with HBOT in order to prevent 1 amputation in the short term (NNT 4, 95% CI 3 to 11). There was no statistically significant difference in minor amputation rate (pooled data of two trials with 48 patients). Healing rates were reported in one trial (Abidia 2003) which showed a significant improvement in the chance of healing 1 year after therapy (RR for failure to heal with sham 2.3, 95%CI 1.1 to 4.7, P=0.03), although no effect was determined immediately post HBOT, nor at 6 months. Further, the beneficial effect after 1 year was sensitive to allocation of dropouts.Venous ulcer: (1 trial, 16 patients): This trial reported data at six weeks (wound size reduction) and 18 weeks (wound size reduction and healing rate) and suggested a significant benefit of HBOT in terms of reduction in ulcer area only at 6 weeks (WMD 33%, 95%CI 19% to 47%, P<0.00001). Arterial and pressure ulcers: No trials that satisfied inclusion criteria were located. REVIEWERS' CONCLUSIONS: In people with foot ulcers due to diabetes, HBOT significantly reduced the risk of major amputation and may improve the chance of healing at 1 year. The application of HBOT to these patients may be justified where HBOT facilities are available, however economic evaluations should be undertaken. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously however, and an appropriately powered trial of high methodological rigour is justified to verify this finding and further define those patients who can be expected to derive most benefit from HBOT. Regarding the effect of HBOT on chronic wounds associated with other pathologies, any benefit from HBOT will need to be examined in further, rigorous randomised trials. The routine management of such wounds with HBOT is not justified by the evidence in this review.

Publication Types:

• Review

Hyperbaric oxygenation accelerates the healing rate of nonischemic chronic diabetic foot ulcers: a prospective randomized study

Diabetes Care. 2003 Aug;26(8):2378-82

Kessler L, Bilbault P, Ortéga F, Grasso C, Passemard R, Stephan D, Pinget M, Schneider F.

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 +/- 9.7 years, diabetes duration 18.2 +/- 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 +/- 18.1 mmHg (room air). During HBO, the TcPO(2) measured around the ulcer increased significantly from 21.9 +/- 12.1 to 454.2 +/- 128.1 mmHg (P < 0.001). At day 15 (i.e., after completion of HBO), the size of ulcers decreased significantly in the HBO group (41.8 +/- 25.5 vs. 21.7 +/- 16.9% in the control group [P = 0.037]). Such a difference could no longer be observed at day 30 (48.1 +/- 30.3 vs. 41.7 +/- 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.

Publication Types:

• prospective randomized study

Hyperbaric oxygen (HBO) therapy in treatment of diabetic foot ulcers. Long-term follow-up

J Diabetes Complications. 2002 Mar-Apr;16(2):153-8

Kalani M, Jörneskog G, Naderi N, Lind F, Brismar K.

BACKGROUND: The cause of diabetic foot ulcers is multifactorial, e.g., neuropathy and angiopathy, leading to functional disturbances in the macrocirculation and skin microcirculation. Adequate tissue oxygen tension is an essential factor in infection control and wound healing. Hyperbaric oxygen (HBO) therapy, daily sessions of oxygen breathing at 2.5-bar increased pressure in a hyperbaric chamber, has beneficial actions on wound healing including antimicrobial action, prevention of edema and stimulation of fibroblasts. The aim of the present study was to investigate the long-term effect of HBO in treatment of diabetic foot ulcers. METHODS: Thirty-eight diabetic patients (30 males) with chronic foot ulcers were investigated in a prospective study. The mean age was 60+/-13 years and the mean diabetes duration 27+/-14 years. All patients were evaluated with measurements of transcutaneous oxygen tension (tcPO(2)), peripheral blood pressure, and HbA(1c). All patients had a basal tcPO(2) value lower than 40 mmHg, which increased to >/=100 mmHg, or at least three times the basic value, during inhalation of pure oxygen. Seventeen patients underwent 40-60 sessions of HBO therapy, while 21 patients were treated conventionally. The follow-up time was 3 years. RESULTS: 76% of the patients treated with HBO (Group A) had healed with intact skin at a follow-up time of 3 years. The corresponding value for patients treated conventionally (Group B) was 48%. Seven patients (33%) in Group B compared to two patients (12%) in Group A went to amputation. Peripheral blood pressure, HbA(1c), diabetes duration, and basal values of tcPO(2) were similar in both groups. CONCLUSIONS: Adjunctive HBO therapy can be valuable for treating selected cases of hypoxic diabetic foot ulcers. It seems to accelerate the rate of healing, reduce the need for amputation, and increase the number of wounds that are completely healed on long-term follow-up. Additional studies are needed to further define the role of HBO, as part of a multidisciplinary program, to preserve a functional extremity, and reduce the short- and long-term costs of amputation and disability.

Publication Types:

• Long-term follow-up

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

Diabetes Care. 2000 Oct;23(10):1551-5.

Wunderlich RP, Peters EJ, Lavery LA.

OBJECTIVE: 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.

Publication Types:

• Review

Systematic review of hyperbaric oxygen in the management of chronic wounds

Br J Surg. 2005 Jan;92(1):24-32

Roeckl-Wiedmann I, Bennett M, Kranke P.

BACKGROUND: Many therapeutic options exist for chronic wounds. Hyperbaric oxygen therapy (HBOT) is one such option. It may be used for diabetic, venous, arterial and pressure ulcers. METHODS: Following a systematic search of the literature, pooled analyses of predetermined clinical outcomes of randomized controlled trials involving the use of HBOT for chronic wounds were performed. Relative risks (RR) and number needed to treat (NNT) with 95 per cent confidence intervals (c.i.) were calculated. RESULTS: Six studies met the inclusion criteria. No appropriate trials were located for arterial and pressure ulcers. Pooled data from five trials on diabetic ulcers (118 patients) suggested a significant reduction in the risk of major amputation with HBOT (RR: 0.31; c.i. 0.13 to 0.71) with a NNT of 4 (c.i. 3 to 11). Sensitivity analyses did not alter the results. Ulcer healing and the rate of minor amputation were not influenced by HBOT. Data from one trial on venous ulcers suggested significant wound size reduction at the end of the treatment, but not at follow-up. CONCLUSIONS: There is evidence that HBOT reduces the risk of major amputation in diabetic patients. For venous, arterial or pressure ulcers there is a lack of data. Further trials may be warranted.

Publication Types:

• Review

Hyperbaric oxygen: its uses, mechanisms of action and outcomes

QJM vol. 97 no. 7 © Association of Physicians 2004; all rights reserved.

A.L. Gill and C.N.A. Bell

Hyperbaric oxygen therapy (HBO) is increasingly used in a number of areas of medical practice. It is a unique intervention whose method of action is not well understood. Clinicians may request its use for their patients, but often will not fully understand its mechanisms. It is hoped that this review and discussion of HBO and the literature surrounding its use may be useful to clinicians who are unsure whether their patients will benefit from this exciting intervention. Hyperbaric oxygen therapy is defined by the Undersea and Hyperbaric Medical Society (UHMS) as a treatment in which a patient intermittently breathes 100% oxygen while the treatment chamber is pressurized to a pressure greater than sea level (1 atmosphere absolute, ATA).1 The pressure increase must be systemic, and may be applied in monoplace (single person) or multiplace chambers. Multiplace chambers are pressurized with air, with oxygen given via face-mask, hood tent or endotracheal tube; while monoplace chambers are pressurized with oxygen. We began by obtaining the most recent UHMS committee report,1 and performed Medline searches (1966 to present), with the search terms ‘hyperbaric’ and ‘oxygen’, combining this basic search with searches for each of the thirteen indications recommended by the UHMS. Using information from these papers, and the resulting references, this paper outlines the history, physiology, current indications for and effects of hyperbaric oxygen therapy.

Publication Types:

• Review