Efficacy of hyperbaric oxygen therapy for diabetic foot ulcer, a systematic review and meta-analysis of controlled clinical trials.

Studies have suggested that hyperbaric oxygen therapy (HBOT) is effective in the healing of diabetic foot ulcer (DFU); however, there is a lack of consensus. Therefore, to assess the efficacy of HBOT on diabetic foot ulcer among diabetic patients, controlled clinical trials were searched through PubMed, EMBASE, Clinical key, Ovid Discovery, ERMED, Clinical Trials.gov databases for randomized controlled trials (RCTs) and other sources until 15 September 2020. Studies that evaluated the effect of HBOT on diabetic foot ulcer, complete healing, amputation, adverse events, ulcer reduction area, and mortality rate were included. Of 1984 study records screened, 14 studies (768 participants) including twelve RCTs, and two CCTs were included as per inclusion criteria. The results with pooled analysis have shown that HBOT was significantly effective in complete healing of diabetic foot ulcer (OR = 0.29; 95% CI 0.14-0.61; I2 = 62%) and reduction of major amputation (RR = 0.60; 95% CI 0.39-0.92; I2 = 24%). Although, it was not effective for minor amputations (RR = 0.82; 95% CI 0.34-1.97; I2 = 79%); however, less adverse events were reported in standard treatment group (RR = 1.68; 95% CI 1.07-2.65; I2 = 0%). Nevertheless, reduction in mean percentage of ulcer area and mortality rate did not differ in HBOT and control groups. This review provides an evidence that hyperbaric oxygen therapy is effective as an adjunct treatment measure for the diabetes foot ulcers. These findings could be generalized cautiously by considering methodological flaws within all studies.

The clinical use of hyperbaric oxygen in the treatment of Danish patients with diabetic foot ulcers.

INTRODUCTION: Patients with diabetic foot ulcers (DFU) suffer from diabetes-related complications and comor-bidities. Hyperbaric oxygen therapy (HBOT) is a treatment modality with limited capacity used in the treatment of DFUs. It is important to ensure that HBOT is offered to patients who are suitable for this treatment regarding effect, compliance and life expectancy. The objective of the present study was to describe the population of patients with DFU who were referred to HBOT in Denmark in the 1999-2016 period. METHODS: All patients with DFU who were treated at the HBOT chamber in Copenhagen during the study period were considered. Patients with an invalid social security number or an incorrect diagnosis were excluded. Data on comor-bidities, amputation and death were extracted from the Danish National patient Registry and the Danish Civil Registration System. Continuous data were described as median values and binary data were described as proportions. The probability estimate for survival and amputation was investigated by constructing Kaplan-Meier curves. RESULTS: The cohort included 148 patients. Patients were mainly referred from the Capital Region (92%) and multi-disciplinary wound care centres were the primary referring departments (67%). Comorbidity rates were high with an initial median Charlson Comorbidity Index score of five. The five-year amputation and mortality estimates after referral were 73.5% and 51.8%, respectively. CONCLUSIONS: The study showed that Danish DFU patients who are offered HBOT are in advanced stages of their disease, and the referral hinges on local factors such as geography and the referring source rather than on standardised procedures. FUNDING: none. TRIAL REGISTRATION: not relevant.

Cost and mortality data of a regional limb salvage and hyperbaric medicine program for Wagner Grade 3 or 4 diabetic foot ulcers.

We obtained costs and mortality data in two retrospective cohorts totaling 159 patients who have diabetes mellitus and onset of a diabetic foot ulcer (DFU). Data were collected from 2005 to 2013, with a follow-up period through September 30, 2014. A total of 106 patients entered an evidence-based limb salvage protocol (LSP) for Wagner Grade 3 or 4 (WG3/4) DFU and intention-to-treat adjunctive hyperbaric oxygen (HBO2) therapy. A second cohort of 53 patients had a primary lower extremity amputation (LEA), either below the knee (BKA) or above the knee (AKA) and were not part of the LSP. Ninety-six of 106 patients completed the LSP/HBO2with an average cost of USD $33,100. Eighty-eight of 96 patients (91.7%) who completed the LSP/HBO2had intact lower extremities at one year. Thirty-four of the 96 patients (35.4%) died during the follow-up period. Costs for a historical cohort of 53 patients having a primary major LEA range from USD $66,300 to USD $73,000. Twenty-five of the 53 patients (47.2%) died. The difference in cost of care and mortality between an LSP with adjunctive HBO2therapy vs. primary LEA is staggering. We conclude that an aggressive limb salvage program that includes HBO2 therapy is cost-effective.

Diabetic foot infection in hospitalized adults.

BACKGROUND: Acute infections of the diabetic foot (DFI) are a common and complex condition. Patients are generally managed in the ambulatory setting and epidemiological data pertaining to hospitalized patients is lacking. The aim of this study was to analyze the epidemiology, microbiology and outcomes of hospitalized patients with DFI, who are managed at a referral center equipped with hyperbaric oxygen (HBO) therapy. METHODS: A retrospective cohort study of adult patients admitted to a tertiary referral center with DFI over a six-month period in 2013 was undertaken. Predictors of clinical outcomes and efficacy of treatment modalities were analyzed by Cox regression. RESULTS: Sixty-one patients with DFI were identified. Most patients were elderly (67 ± 13 years), with long-standing (17 ± 9 years), poorly controlled (HbA1c 9 ± 3%) diabetes. Most patients had polymicrobial infection (80%); specifically, anaerobic (39%) and multi or extensively-drug resistant organisms (61%). Administration of appropriate antimicrobials was delayed for >48 h in 83%. Advanced age was associated with worse outcomes. Sicker patients with severe peripheral vascular disease were managed with HBO. The use of HBO was associated with higher costs and increased functional deterioration, and did not prevent future limb amputation. CONCLUSIONS: Our study illustrates the descriptive epidemiology of hospitalized adults with DFI predominantly of polymicrobial etiology. MDROs and anaerobic organisms are common causative pathogens, and appropriate antibiotics were frequently delayed. HBO treatment may delay the need for limb amputation, but not obviate this eventual outcome.

Reducing lower leg amputations in diabetes: a challenge for patients, healthcare providers and the healthcare system.

Amputation of the lower limb is one of the most feared diabetic complications. It is associated with loss of mobility and a poor quality of life. Amputations result in high economic burden for the healthcare system. The financial cost is also high for patients and their families, particularly in countries that lack a comprehensive health service and/or have a low income. Losing a leg frequently implies financial ruin for a whole family in these countries; therefore, a reduction in diabetes-related amputations is a major global priority. Marked geographical variation in amputation rates has been reported within specific regions of an individual country and between countries. A coordinated healthcare system with a multidisciplinary approach is essential if the number of amputations is to be reduced. This commentary discusses how studies on the variation in amputation rates can help to identify barriers in the access or delivery of care with the aim of reducing the burden of diabetic foot disease.

Hyperbaric oxygen therapy facilitates healing of chronic foot ulcers in patients with diabetes.

OBJECTIVE: Chronic diabetic foot ulcers are a source of major concern for both patients and health care systems. The aim of this study was to evaluate the effect of hyperbaric oxygen therapy (HBOT) in the management of chronic diabetic foot ulcers. RESEARCH DESIGN AND METHODS: The Hyperbaric Oxygen Therapy in Diabetics with Chronic Foot Ulcers (HODFU) study was a randomized, single-center, double-blinded, placebo-controlled clinical trial. The outcomes for the group receiving HBOT were compared with those of the group receiving treatment with hyperbaric air. Treatments were given in a multi-place hyperbaric chamber for 85-min daily (session duration 95 min), five days a week for eight weeks (40 treatment sessions). The study was performed in an ambulatory setting. RESULTS: Ninety-four patients with Wagner grade 2, 3, or 4 ulcers, which had been present for >3 months, were studied. In the intention-to-treat analysis, complete healing of the index ulcer was achieved in 37 patients at 1-year of follow-up: 25/48 (52%) in the HBOT group and 12/42 (29%) in the placebo group (P = 0.03). In a sub-analysis of those patients completing >35 HBOT sessions, healing of the index ulcer occurred in 23/38 (61%) in the HBOT group and 10/37 (27%) in the placebo group (P = 0.009). The frequency of adverse events was low. CONCLUSIONS: The HODFU study showed that adjunctive treatment with HBOT facilitates healing of chronic foot ulcers in selected patients with diabetes.

Can major amputation rates be decreased in diabetic foot ulcers with hyperbaric oxygen therapy?

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.

Pie diabético: evolución en una serie de 121 pacientes / Evolution of diabetic foot in a series of 121 patients

Cohorte única de 121 pacientes portadores de pie diabético (PD) tratados entre 1998 y 2005. Se analiza la evolución, a través de incidencia de cicatrización, recidiva, amputación al año, a los tres años y letalidad. El origen del PDfue predominantemente neuropático en 52 pacientes (43 por ciento), predominantemente isquémico en 44 (36.4 por ciento) y mixto en 25 casos (20.6 por ciento). En 78 casos (64.5 por ciento) había infección asociada. Las lesiones mayores que Wagner 1 tuvieron cicatrización significativamente menor, p < 0.05. La media de antigüedad de la úlcera fue 10.8 semanas. La tasa de cicatrización, 31.4 por ciento y el tiempo medio de cicatrización, 6.2 semanas; la tasa de recidiva de la úlcera durante el primer año fue 52.1 por ciento. La media de tiempo para la recidiva de la úlcera fue 5.1 meses. La tasa de amputación al año de diagnosticada la úlcera fue 95.9 por ciento y 98.3 por ciento a los tres años. La tasa de reamputación de amputaciones menores fue 55.4 por ciento y de amputaciones mayores fue 24.4 por ciento, p < 0.05. La media entre el inicio del tratamiento y la amputación fue 11 semanas. La cirugía de rescate no modificó el desenlace de amputación (p =0.98). La letalidad fue 4.1 por ciento. Los grupos de riesgo de amputación fueron: diabéticos tipo 2 y lesiones Wagner 2 y superiores. Nuestro pobre desenlace del PD requiere implementar un plan de educación para reducir la aparición de úlcera y/ o infección local, disminuir la recidiva, mejorar la educación de los diabéticos respecto al cuidado de los pies y, replantear los niveles de amputaciones en el PD avanzado.

Background: Fifteen percent of diabetic patients will develop a foot ulcer during their lifetime. The predisposing conditions are neuropathy, ischemia and infections. Aim: To report the incidence of healing, relapse, amputation and mortality of diabetic foot in a period of eight years. Material and methods: A cohort of 134 patients hospitalized in a Surgical Service with the diagnosis of diabetic foot was studied; however in 13 patients, the clinical history was not available. Therefore the series included 81 males aged 68 + 11 years and 40 females aged 72 + 11 years. Results: Diabetic foot was predominantly neuropathic in 52 patients (43 percent), predominantly ischemic in 44 (36 percent) and mixed in 25 (21 percent). An associated infection was found in 78 patients (65 percent). The mean ulcer duration was 11 weeks. The rate of healing was 31 percent and the mean healing lapse was 6.2 weeks. The rate of relapse in the first year was 52 percent. The mean relapse time was 5.1 months. The amputation rate was 96 percent one year after diagnosis and 98 percent, three years after diagnosis. Minor and major amputation rates were 55 and 24 percent, respectively. The mean lapse between treatment onset and amputation was 11 weeks. Rescue surgical procedures did not modify the evolution of diabetic foot. Four percent of patients died. Conclusions: The overall results of diabetic foot treatment are poor. Therefore the efforts must be placed on prevention and education of patients to prevent the appearance of foot ulcers, local infections, diabetic foot relapse.

An integrated care pathway to save the critically ischaemic diabetic foot.

This prospective study describes and evaluates the efficacy of an integrated care pathway for the management of the critically ischaemic diabetic foot patients by a multidisciplinary team. A weekly joint diabetes/vascular/podiatry ward round and outpatient clinic was established where patients were assessed within 7 days of referral by clinical examination, ankle-brachial-index-pressures, duplex angiogram and transcutaneous oxygen pressures. An angiogram +/- angioplasty or alternatively a magnetic resonance angiography prior to surgical revascularisation was performed in patients deemed not suitable for angioplasty based on the above vascular assessment. Between January 2002 and June 2003(18 months), 128 diabetic patients with lower limb ischaemia were seen. Thirty-four (26.6%) patients received medical treatment alone, and 18 (14.1%) were deemed 'palliative' due to their significant co-morbidities. The remaining 76 (59.4%) patients underwent either angioplasty (n = 56), surgical reconstruction (n = 18), primary major amputation (n = 2) or secondary amputation after surgical revascularisation (n = 1). Minor toe amputations were required in 35 patients. The mortality in the intervention group was 14% (11/76). This integrated multidisciplinary approach offers a consistent and equitable service to diabetic patients with critically ischaemic feet and appears to have a beneficial major/minor amputation ratio.