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.     

Treatment of diabetic foot complications with hyperbaric oxygen therapy: A retrospective experience

BackgroundThe aim of this study is to evaluate the role of hyperbaric oxygen in the treatment of diabetic foot ulcers.MethodsWe performed a retrospective observational study of all patients with diabetic foot ulcers treated at the Institution's hyperbaric chamber between January 2010 and August 2012. Patient data was obtained upon patient hospital visit and prospective clinical record consultation.ResultsTwenty-six foot lesions including 13 foot ulcers Wagner grade 2 or greater and 13 amputation stump ulcers were submitted to hyperbaric oxygen therapy between January 2010 and August 2012 in our Institution. Of these, 23 foot lesions completed treatment and complete epithelialization of the primary lesion was achieved in 15 (65%). The mean healing period since the first hyperbaric oxygen therapy session was 16 weeks. Above-ankle amputations were performed in 3 limbs and transmetatarsal amputations in 2 limbs.ConclusionHyperbaric oxygen may be associated with ulcer healing in selected diabetic foot ulcers with impaired cicatrization.     

A systematic review and meta-analysis of hyperbaric oxygen therapy for diabetic foot ulcers with arterial insufficiency

BackgroundDiabetic foot ulcers (DFUs) are frequently associated with peripheral arterial occlusive disease (PAOD) and may ultimately lead to amputations of the lower extremity. Adjuvant hyperbaric oxygen treatment (HBOT) might foster better wound healing and lower amputation rates in patients with DFU and PAOD. A systematic review was conducted to assess the effects of HBOT as an adjunctive therapy to standard treatment for patients with DFUs with PAOD.MethodsSystematic review using the MEDLINE, EMBASE, and Cochrane CENTRAL databases (from inception to October 2018). All original, comparative studies on the effect of HBOT on DFUs with PAOD were eligible. The primary outcome measures were amputation rate, amputation-free survival, complete ulcer healing, and mortality.ResultsEleven studies, totaling 729 patients, were included for analysis, including 7 randomized clinical trials, 2 controlled clinical trials, and 2 retrospective cohorts. Four were used for quantitative synthesis. Meta-analysis showed a significantly fewer major amputations in the HBOT group (10.7% vs 26.0%; risk difference, −15%; 95% confidence interval [CI], −25 to −6; P = .002; number needed to treat, 7; 95% CI, 4-20). No difference was found for minor amputations (risk difference, 8%; 95% CI, −13 to 30; P = .46). Three studies reporting on complete wound healing showed contrasting results. No significant difference was found for mortality or amputation-free survival.ConclusionsCurrent evidence shows that adjuvant HBOT improves major amputation rate, but not wound healing, in patients with DFUs and PAOD. Given the wide range of patients included in the trials, better patient selection may help define which patients with DFUs and PAOD benefit most from HBOT as standard adjunctive treatment.     

Hyperbaric oxygen for the treatment of nonhealing arterial insufficiency ulcers

There is limited data regarding hyperbaric oxygen's effectiveness in the treatment of nonhealing arterial insufficiency ulcers. This study was designed to analyze healing rates and amputation rates in patients who underwent adjunctive hyperbaric oxygen for a nonhealing arterial insufficiency ulcer. A retrospective chart review was completed on patients who underwent hyperbaric oxygen for arterial insufficiency ulcers that failed to heal despite standard treatment. Information collected included complete ulcer healing, amputation, and patient characteristics. There were 82 patients identified. A majority did not have diabetes (84.1%). The overall rate of healing was 43.9%. The overall major amputation rate was 17.1%. The amputation rate among those who healed was 0% compared to 42.4% among those not healed (p < 0.0001). Dialysis was predictive of major amputation (p = 0.03). Our findings suggest hyperbaric oxygen can play a role in management of arterial insufficiency ulcers that have failed standard treatment. The overwhelming majority of these patients did not have diabetes, which allows this study to be translated to patients with a primary arterial insufficiency ulcer. These results support the use of hyperbaric oxygen for select nonhealing arterial insufficiency ulcers that have failed standard therapy and the need for a prospective pilot study.     

A prospective study: hyperbaric oxygen therapy in diabetics with chronic foot ulcers

Research suggests that hyperbaric oxygen therapy may have beneficial effects on ulcer healing and amputation rates in diabetic patients. This paper describes the design of a study that is evaluating its effects on chronic diabetic foot ulcers.     

Efficacy of Hyperbaric Oxygen Therapy in Diabetic Foot Ulcers Based on Wagner Classification

Diabetic foot ulcer is a common chronic complication of diabetes mellitus. In addition to conventional primary therapy, there are adjuvant therapy methods such as hyperbaric oxygen therapy for the healing of diabetic foot ulcer wounds. The present study aimed to determine the efficacy of hyperbaric oxygen therapy in diabetic foot ulcers based on Wagner classification. It was performed retrospectively from prospectively collected data. One hundred thirty patients with diabetic foot ulcers were assessed in 2 groups: 1 group received hyperbaric oxygen therapy; the other group did not. Patients were examined according to age, sex, ulcer grade based on Wagner classification; ulcer healing status; whether hyperbaric oxygen therapy was received; duration of diabetes in years; HbA1C, sedimentation, C-reactive protein levels; and presence of accompanying diseases, including peripheral arterial disease, chronic obstructive pulmonary disease, hypertension, chronic kidney disease, neuropathy, and retinopathy. The mean follow-up period was 19.5?±?4.45 months (range 12 to 28 months). Seventy-one (54.6%) patients received hyperbaric oxygen therapy, and 59 (45.4%) patients did not. All patients in Wagner grade 2 healed in both groups. In the group that received hyperbaric oxygen therapy for grade 3 and 4 patients, 35 (87.5%) and 11 (84.6%) healed, respectively. In total, 60 (84.5%) patients in the group that received hyperbaric oxygen therapy healed. The subgroup comparison conducted according to Wagner classification revealed no differences between the 2 groups of grades 2 and 5 patients. It also revealed that treatment had higher levels of efficacy in the healing of ulcers in grade 3 and 4 patients.     

Hyperbaric oxygen therapy of diabetic foot ulcers, transcutaneous oxymetry in clinical decision making

The foot ulcer is one of most common and devastating complications of diabetes and is associated with considerable morbidity and mortality. The major causes of these ulcers are ischemia/hypoxia, neuropathy, and infection, and they often coexist. Despite conventional therapy including revascularization procedures when appropriate, three situations lead frequently to amputation: persistent critical limb ischemia, soft tissue infection, and impaired wound healing from osteomyelitis. In these conditions, hyperbaric oxygen therapy may be used as an adjunctive treatment and is associated with a better outcome. Randomized, prospective, controlled trails have shown the benefit of hyperbaric oxygen therapy in diabetic ulcers of the lower extremity. Transcutaneous oxygen measurement performed under hyperbaric oxygen therapy has a prognostic significance when used to select patients who are the most likely to benefit from therapy. Hyperbaric oxygen should be added to conventional treatment if the transcutaneous oxygen tension close to the trophic lesion in 2.5 ATA hyperbaric oxygen is over 200 mmHg. Peri-wound transcutaneous oxygen tensions over 400 mmHg in 2.5 ATA hyperbaric oxygen or over 50 mmHg in normobaric pure oxygen predict healing success with adjuncted hyperbaric oxygen therapy with high accuracy.     

负压创面治疗联合高压氧治疗糖尿病足的临床疗效

目的 探讨负压创面治疗联合高压氧治疗糖尿病足的临床疗效.方法 采用回顾性病例对照研究分析江苏大学附属人民医院整形烧伤科自2013年2月至2017年12月收治的46例糖尿病足患者的临床资料,根据治疗方法分为对照组(24例)和联合治疗组(22例).糖尿病足创面按Wagner分级为3～5级;共46足.对照组采用控制血糖、抗感...     

Prevention and treatment of diabetic foot wounds

The diabetic foot ulcer is one of the most common and devastating complications of diabetes mellitus. These ulcers account for most of the hospital admissions for patients with diabetes, and they represent a common precursor for amputation. When a diabetic foot ulcer becomes infected, gangrene and amputation can follow in rapid succession. Recent reviews concerning diabetic foot lesions and amputations have stressed the magnitude and importance of aggressive management. This management is complicated, and typically requires radical débridement, appropriate antibiotics, non-weight-bearing, and vascular surgery when indicated. A variety of adjunctive therapy can be helpful, including hyperbaric oxygen and topical growth factors. The most important step in preventing ulceration of the foot is patient education in foot care.     

Interdisciplinary treatment of diabetic foot syndrome

The amputation rate in patients with diabetic foot syndrome (DFS) in Germany is still as high as 28,000 per year. Ischemia and osteomyelitis often complicate the DFS. Impaired wound healing frequently requires further surgery with a higher amputation level. The results of treating patients with DFS in our specialized foot care center were evaluated in order to assess our interdisciplinary strategy. Advanced diabetic foot wounds in patients with ischemia and osteomyelitis first require diagnostics concerning polyneuropathy, osteomyelitis, and blood supply. If peripheral arterial vessel disease is present, surgical revascularization by distal bypass grafting is the first and crucially important element of the interdisciplinary approach. Minor amputation or elective resection of the infected bone improves wound healing. Post-interventional care for wounds with secondary healing and prevention of new ulcers are provided in a foot care clinic specialized in diabetes. The clinical and radiological results of 77 patients who underwent this treatment algorithm including bypass surgery and bone resection within 1 year were collected using a standardized questionnaire. Those results were subjected to a historical comparison. Only three patients needed further intervention because of persisting ulcers and osteomyelitis. The frequency of major amputations in all patients with DFS and ischemia combined with osteomyelitis was low (10.3%). This interdisciplinary concept of treatment guarantees a high healing rate in patients even with osteomyelitis and ischemia and allows the reduction of the rate of major amputations. The data obtained allow a fact-based design for future studies.     

Effect of systemic insulin treatment on diabetic wound healing

This study investigates if different diabetic treatment regimens affect diabetic foot ulcer healing. From January 2013 to December 2014, 107 diabetic foot ulcers in 85 patients were followed until wound healing, amputation or development of a nonhealing ulcer at the last follow‐up visit. Demographic data, diabetic treatment regimens, presence of peripheral vascular disease, wound characteristics, and outcome were collected. Nonhealing wound was defined as major or minor amputation or those who did not have complete healing until the last observation. Median age was 60.0 years (range: 31.1–90.1 years) and 58 cases (68.2%) were males. Twenty‐four cases reached a complete healing (healing rate: 22.4%). The median follow‐up period in subjects with classified as having chronic wounds was 6.0 months (range: 0.7–21.8 months). Insulin treatment was a part of diabetes management in 52 (61.2%) cases. Insulin therapy significantly increased the wound healing rate (30.3% [20/66 ulcers] vs. 9.8% [4/41 ulcers]) (p = 0.013). In multivariate random‐effect logistic regression model, adjusting for age, gender, smoking status, type of diabetes, hypertension, chronic kidney disease, peripheral arterial disease, oral hypoglycemic use, wound infection, involved side, presence of Charcot's deformity, gangrene, osteomyelitis on x‐ray, and serum hemoglobin A1C levels, insulin treatment was associated with a higher chance of complete healing (beta ± SE: 15.2 ± 6.1, p = 0.013). Systemic insulin treatment can improve wound healing in diabetic ulcers after adjusting for multiple confounding covariates.     

Treatment of diabetic foot ulcers with hyperbaric oxygen

The delivery of oxygen to the wound site is crucial in healing diabetic foot ulcers, and impairment of this process in people with diabetes leads to delayed wound repair. Hyperbaric oxygen therapy works by elevating the plasma oxygen level. Fibroblasts synthesise and modify collagen, and both these activities require relatively high partial pressures of oxygen. Hyperbaric oxygen can promote healing by stimulating fibroblast activity and collagen formation. Increasing oxygen tensions also has a direct and toxic effect on anaerobes, therefore hyperbaric oxygen therapy has a special role in treating diabetic foot infections. Studies on hyperbaric oxygen therapy in general show it to be a beneficial adjunctive therapy for diabetic foot ulcers. However much of the work is anecdotal and more controlled trials are required.     

Local signs and symptoms in relation to final amputation level in diabetic patients: A prospective study of 187 patients with foot ulcers

Local signs and symptoms were evaluated in 187 consecutively presenting diabetic patients undergoing amputation for foot ulcers. From admission until final outcome the patients were treated by the same multidisciplinary team both as in- and outpatients. At the time of amputation, the types of lesions were superficial/deep ulcer (n 17), ulcer with deep infection, but without gangrene (n 40), and gangrene with or without infection (n 130). Healing after a minor amputation (below the ankle) occurred in 74 patients, while 88 patients healed after a major amputation (above the ankle), and 25 patients died before healing had occurred. Deep infection and presence of popliteal or pedal pulses were associated with healing after minor amputation and so were ulcers on the small toes, metatarsal head area and midfoot. Pain, progressive gangrene, intermittent claudication, and decubital and multiple ulcers were related to healing after major amputation. In a logistic regression analysis, pain, progressive gangrene and intermittent claudication remained. However, none of these factors excluded healing of a minor amputation and thus selection of amputation level in diabetic patients with foot ulcers cannot be based upon these factors exclusively.     

Amputations in diabetic patients: a plea for footsparing surgery

The authors observed a rather high rate of primary major amputation (above-knee or below-knee) performed for diabetic foot problems as well as an important revision rate for minor amputations (forefoot or toe) in diabetics. They reviewed their experience in order to compare it with more recent data from the literature, pleading for foot-sparing surgery. From 1993 to 1998, 186 amputations were performed on 146 diabetic patients. The cause of foot ulcers was neuropathy in 43 of them (51 episodes of diabetic foot problems) while in the remaining 103 patients (135 episodes of diabetic foot problems), diabetic macroangiopathy (absent ankle pulses) was on cause. For neuropathic foot problems, amputations were almost minor, resulting in a limb salvage rate of 90%. Only five of these patients (12%) had primary major limb amputation versus 43 of the dysvascular patients (42%). The reasons for major amputation by first intention were extensive tissue loss, intractable infection or non-reconstructible occlusive vessel disease, as judged by the surgeon. A foot-sparing surgery was attempted in 92 dysvascular cases. In only 44 of them, a preliminary vascular repair was performed. Twenty eight percent of the primary toe amputations and 24% of the forefoot amputations required secondary revision to a more proximal level. Minor amputations in case of diabetic neuropathy were characterized by a more favourable outcome: only 14% of the toe and 9% of the forefoot amputations failed. During follow-up, only 63% of the major amputations regained an autonomic walking capability with their prosthesis. Wound healing problems in diabetic foot are mainly due to infection and poor tissue perfusion. An aggressive control of the infection and distal revascularization of calf- or foot arteries, whenever possible, could improve the results of diabetic foot surgery. The poor functional recovery after major amputation (only 63% autonomic gait with limb prosthesis) argues for foot-sparing surgery whenever possible.     

Das diabetische Fußsyndrom

There are more than 6 million diabetic patients in Germany. The number of patients with “diabetic foot syndrome” has been increasing dramatically over the past years. Many of the 200.000 newly discovered diabetic foot ulcers per year become chronic wounds. Despite all efforts for prevention, early diagnosis and adequate wound care there are 20.000 diabetics undergoing major limb amputation in Germany every year. With a consistent strategy of prevention, many foot ulcers can be avoided, and the recurrence rate can be decreased. Also, many amputations can be avoided if an improvement of arterial perfusion was to be considered early. With consistent therapy in interdisciplinary centers and by applying all methods of arterial revascularization, the amputation rate in patients with diabetic foot problems can be reduced by 80%.     

Platelet-rich plasma versus platelet-poor plasma in the management of chronic diabetic foot ulcers: a comparative study

Non healing diabetic foot ulcers and the resulting potential amputations present significant costs to the health care system and reduce patient quality of life. The goal of diabetic foot ulcer treatment is to obtain wound closure as expeditiously as possible. The use of platelet-rich plasma (PRP) to enhance wound healing has increased dramatically over the last decade. However, controversies exist in the literature regarding the added benefit of this procedure. The aim of this study is to investigate the efficiency of platelet releasate on the healing of chronic diabetic ulcers in comparison with platelet-poor plasma (PPP). This study included 24 patients with chronic diabetic ulcers. They were systematically randomised into two groups: PRP group (n = 12) and PPP group (n = 12). The results showed that healing in PRP group was significantly faster (P < 0·005). PRP enhances healing of chronic diabetic foot ulcers.     

Total-contact casting as an adjunct to promote healing of pressure ulcers in amputees

Partial foot amputations have become increasingly prevalent among long-lived diabetic patients. These patients have lower extremity neuropathy and are prone to ulceration at their amputation site. These ulcers are difficult to heal, and they place a significant financial and resource burden on the healthcare system. We examined the efficacy of total-contact casts (TCC) in diabetic amputees with nonhealing partial foot amputation site neuropathic ulcers. Data were collected retrospectively on all patients with amputations who were treated with a total-contact cast between December 2000 and December 2003. Seventeen patients (13 men, 4 women) with amputation site ulceration were identified. All patients were diagnosed with neuropathy secondary to diabetes and none had wound healing compromised by ischemia. The initial ulcer averaged 1,169 mm(2) with a depth of 2.77 mm. Patients were treated with an average of 7.9 cast applications over 8.4 weeks; 47% (8/17) of ulcers healed, but 29% (5/17) of patients were unable to complete their recommended treatment course secondary to complications from the TCC. Of the patients who were able to complete their treatment course, the healing rate was 66.7% (8/12). The recurrence rate for healed ulcers was 63% (5/8). Partial foot amputations with neuropathic ulcers present a very difficult problem to the vascular surgeon. Patient compliance and underlying medical comorbidities limit the success rate. In patients who can complete a TCC treatment course, good short term results can be expected. However, recurrence rates are high following discontinuation of mechanical TCC off-loading.     

Diabetic foot ulcers treated with hyperbaric oxygen therapy: a review of the literature

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 the patients received hyperbaric oxygen twice rather than once daily. Reduced amputation rates and improved healing were the most common outcomes observed.     

Systematic review of hyperbaric oxygen in the management of chronic wounds

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.     

Effect of lower extremity amputation on caregiving burden in caregivers of patients with diabetic foot: Prospective cohort study

Lower extremity amputation as a treatment of diabetic foot ulcer is probably a major burden for the patient's family and friends, who typically act as caregivers and support the patient in coping with the physical disabilities and emotional distress. In the present prospective study, we investigated the effects of different lower extremity amputation levels for diabetic foot ulcer treatment on caregivers of patients with diabetes using the Zarit Burden Interview (ZBI‐12) scale. Patients with diabetic foot ulcers who underwent unilateral major amputation (above‐below knee) and minor amputation of foot (heel sparing) and their caregivers were requested to volunteer to participate in this study from June 2016 to December 2018. The ZBI‐12 form was completed immediately preoperatively and 3 and 6 months after postoperatively. In the minor amputation group, the mean age of the 51 patients was 72.1 years. In the major amputation group, the mean age of the 88 patients was 73.7 years. Both groups of caregivers of patients with minor amputation and major amputations showed a significant improvement in ZBI‐12 score when compared preoperatively and at 3‐ and 6‐month follow‐up visits. The mean ZBI‐12 score was significantly higher in the major than in the minor amputation group in preoperative and all postoperative visits. The absence of the ankle joint in the below‐ or above‐knee amputation renders it more difficult for the amputee to quickly learn the use of prosthesis, thereby increasing the burden of the patient and caregivers. We found that lower extremity amputation for the treatment of chronic diabetic foot ulcers has significantly favourable effect on the caregiver burden, and thereby heel sparing was considerably more effective for the caregiver burden.