This study reports on the case of an elderly patient, with diabetes, and a bullous wound on the left big toe that led to an amputation of the first and second left toes. The amputation was because of deep injury as it was not able to heal with a conventional treatment. After completing the normal treatment and the removal of a bacterial infection in the lesion, the patient underwent a treatment that was based on a hydrogel gel (0.9% saline solution) and hyperbaric oxygen therapy (HBOT). After 60 sessions of the therapy, almost complete closure of the wound was observed. There were no reports of discomfort or infection during the treatment. After seven months of treatment almost complete healing was observed with no infection. This treatment appears to be effective and should be recommended for the treatment of DFUs.

Diabetes mellitus (DM) is a significant international health concern affecting more than 387 million individuals. A diabetic person has a 25% lifetime risk of developing a diabetic foot ulcer (DFU), leading to limb amputation in up to one in six DFU patients. Low-level light therapy (LLLT) uses low-power lasers or light-emitting diodes to alter cellular function and molecular pathways, and may be a promising treatment for DFU. The goal of this systematic review is to examine whether the clinical use of LLLT is effective in the healing of DFU at 12 weeks and 20 weeks in comparison with the standard of care, and to provide evidence-based recommendation and future clinical guidelines for the treatment of DFU using LLLT. On September 30(th) 2015, we searched PubMed, EMBASE, CINAHL, and Web of Science databases using the following terms:"diabetic foot"AND"low level light therapy,"OR"light emitting diode,"OR"phototherapy,"OR"laser."The relevant articles that met the following criteria were selected for inclusion: randomized control trials (RCTs) that investigated the use of LLLT for treatment of DFU. Four RCTs involving 131 participants were suitable for inclusion based upon our criteria. The clinical trials used sham irriadiation, low dose, or non-therapeutic LLLT as placebo or control in comparison to LLLT. The endpoints included ulcer size and time to complete healing with follow-up ranging from 2 weeks to 16 weeks. Each article was assigned a level of evidence (LOE) and graded according to the Oxford Center for Evidence-based Medicine Levels of Evidence Grades of Recommendation criteria. Limitations of reviewed RCTs include a small sample size (N<100), unclear allocation concealment, lack of screening phase to exclude rapid healers, unclear inclusion/exclusion criteria, short (<30 days) follow-up period, and unclear treatment settings (wavelength and treatment time). However, all reviewed RCTs demonstrated therapeutic outcomes with no adverse events using LLLT for treatment of DFU. This systematic review reports that LLLT has significant potential to become a portable, minimally invasive, easy-to-use, and cost effective modality for treatment of DFU. To enthusiastically recommend LLLT for treatment of DFU, additional studies with comparable laser parameters, screening period to exclude rapid healers, larger sample sizes and longer follow-up periods are required. We envision future stringent RCTs may validate LLLT for treatment of DFU. Systematic review registration number: PROSPERO CRD42015029825. This article is protected by copyright. All rights reserved.

PURPOSE:The purpose of this study was to compare the effect of standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care alone on wound healing, markers of inflammation, glycemic control, amputation rate, survival rate of tissue, and health-related quality of life in patients with diabetic foot ulcers (DFUs).

DESIGN:Prospective, randomized, open-label, controlled study.

SUBJECTS AND SETTING:The sample comprised 38 patients with nonhealing DFUs who were deemed poor candidates for vascular surgery. Subjects were randomly allocated to an experimental group (standard care plus HBOT, n = 20) or a control group (standard care alone, n = 18). The study setting was a medical center in Kaohsiung City, Taiwan.

METHODS:Hyperbaric oxygen therapy was administered in a hyperbaric chamber under 2.5 absolute atmospheric pressure for 120 minutes; subjects were treated 5 days a week for 4 consecutive weeks. Both groups received standard wound care including debridement of necrotic tissue, topical therapy for Wagner grade 2 DFUs, dietary control and pharmacotherapy to maintain optimal blood glucose levels. Wound physiological indices were measured and blood tests (eg, markers of inflammation) were undertaken. Health-related quality of life was measured using the Medical Outcomes Study 36-Item Short Form.

RESULTS:Complete DFU closure was achieved in 5 patients (25%) in the HBOT group (n = 20) versus 1 participant (5.5%) in the routine care group (n = 18) (P = .001). The amputation rate was 5% for the HBOT group and 11% for the routine care group (χ = 15.204, P = .010). The HBOT group showed statistically significant improvements in inflammation index, blood flow, and health-related quality of life from pretreatment to 2 weeks after the last therapy ended (P<.05). Hemoglobin A1c was significantly lower in the HBOT group following treatment (P<.05) but not in the routine care group.

CONCLUSIONS:Adjunctive HBOT improved wound healing in persons with DFU. Therapy also reduced the risk of amputation of the affected limb. We assert that at least 20 HBOT sessions are required to be effective.

OBJECTIVE: To assess the clinical and microbiological efficacy of maggot debridement therapy (MDT) in the management of diabetic foot ulcers unresponsive to conventional treatment and surgical intervention. METHOD: Consecutive diabetic patients with foot wounds presenting at the vascular surgery unit and the diabetic foot unit of Alexandria Main University Hospital were selected for MDT. Lucilia sericata medicinal maggots were applied to the ulcers for three days per week. Changes in the percentage of necrotic tissue and ulcer surface area were recorded each week over the 12-week follow-up period. Semiquantitative swab technique was used to determine the bacterial load before and after MDT. RESULTS: The sample comprised 10 patients with 13 diabetic foot ulcers. The mean baseline ulcer surface area was 23.5cm2 (range 1.3-63.1), and the mean percentage of necrotic tissue was 74.9% (range 29.9-100). Complete debridement was achieved in all ulcers in a mean of 1.9 weeks (range 1-4). Five ulcers (38.5%) were completely debrided with one three-day MDT cycle. The mean reduction in ulcer size was significant at 90.2%, and this occurred in a mean of 8.1 weeks (range 2-12). The mean weekly reduction in ulcer size was 16.1% (range 8.3-50). Full wound healing occurred in 11 ulcers (84.6%) within a mean of 7.3 weeks (range 2-10). The bacterial load of all ulcers reduced sharply after the first MDT cycle to below the 10(5) threshold, which facilitates healing. CONCLUSION: The results highlight the potential benefits of MDT in diabetic wound care in developing countries. MDT was proved to be a rapid, simple and efficient method of treating these ulcers.

BACKGROUND: The management of diabetic foot ulcers remains a problem. A treatment modality that uses compressed air massage has been developed as a supplement to standard surgical and medical treatment. Compressed air massage is thought to improve local tissue oxygenation around ulcers. The aim of this study was to determine whether the addition of compressed air massage influences the rate of healing of diabetic ulcers. METHODS: Sixty consecutive patients with diabetes, admitted to one hospital for urgent surgical management of diabetic foot ulcers, were randomized into two groups. Both groups received standard medical and surgical management of their diabetes and ulcer. In addition, one group received 15-20 min of compressed air massage, at 1 bar pressure, daily, for 5 days a week, to the foot and the tissue around the ulcer. Healing time was calculated as the time from admission to the time of re-epithelialization. RESULTS: Fifty-seven patients completed the trial; 28 received compressed air massage. There was no difference in the mean age, Wagner score, ulcer size, pulse status, or peripheral sensation in the two groups. The time to healing in the compressed air massage group was significantly reduced: 58.1 +/- 22.3 days (95% confidence interval: 49.5-66.6) versus 82.7 +/- 30.7 days (95% confidence interval: 70.0-94.3) (P = 0.001). No adverse effects in response to compressed air massage were noted. CONCLUSIONS: The addition of compressed air massage to standard medical and surgical management of diabetic ulcers appears to enhance ulcer healing. Further studies with this new treatment modality are warranted.

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.

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.

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.

BACKGROUND:Diabetic foot ulcers (DFU) represent a significant complication of diabetes mellitus (DM). DFU affect one in four patients with DM and treatments of DFU are limited and challenging. The management of DFU remains a significant healthcare and socioeconomic burden ($245 billion). There is a wide range of advanced therapies for DFU, but these are costly and have demonstrated only minimal efficacy in limited published studies. An emerging treatment modality to improve DFU and optimize wound healing is the use of low-level light therapy (LLLT). LLLT involves the use of light in the form of low-level or low-power laser or light emitting diodes to alter biochemical pathways, which may result in changes to cell shape, cell migration, and cell signaling.

OBJECTIVE:To review published clinical experiences (case series and case reports) using LLLT for treatment of DFU, and provide evidence-based recommendations and future directions on the potential of LLLT as a therapeutic modality for DFU.

METHODS AND MATERIALS:On January 16, 2016 we searched the published literature using databases: PubMed, EMBASE, CINAHL, and Web of Science with key terms:"diabetic foot"AND ("low level laser therapy"OR"low level light therapy"OR"LLLT"OR"light emitting diode"OR"phototherapy"OR"laser").

RESULTS:After screening of titles, abstracts and/or full-text, 7 original articles were suitable in our review. Our review contains 5 case series and 2 case reports that evaluated LLLT for treatment of DFU, and all reviewed studies have shown positive improvement of DFU using LLLT with no adverse events, albeit with limitations that may be minimized with future RCTs.

CONCLUSIONS:LLLT is an emerging and promising treatment modality to current alternatives that are costly and have shown limited success. Based upon the published evidence, we envision additional research may allow for stronger recommendation with LLLT for treatment of DFU.

J Drugs Dermatol.2016;15(7):843-848.

OBJECTIVE: To assess the efficacy of maggot therapy for treating foot and leg ulcers in diabetic patients failing conventional therapy. RESEARCH DESIGN AND METHODS: Retrospective comparison of changes in necrotic and total surface area of chronic wounds treated with either maggot therapy or standard (control) surgical or nonsurgical therapy. RESULTS: In this cohort of 18 patients with 20 nonhealing ulcers, six wounds were treated with conventional therapy, six with maggot therapy, and eight with conventional therapy first, then maggot therapy. Repeated measures ANOVA indicated no significant change in necrotic tissue, except when factoring for treatment (F [1.7, 34] = 5.27, P = 0.013). During the first 14 days of conventional therapy, there was no significant debridement of necrotic tissue; during the same period with maggot therapy, necrotic tissue decreased by an average of 4.1 cm(2) (P = 0.02). After 5 weeks of therapy, conventionally treated wounds were still covered with necrotic tissue over 33% of their surface, whereas after only 4 weeks of therapy maggot-treated wounds were completely debrided (P = 0.001). Maggot therapy was also associated with hastened growth of granulation tissue and greater wound healing rates. CONCLUSIONS: Maggot therapy was more effective and efficient in debriding nonhealing foot and leg ulcers in male diabetic veterans than was continued conventional care.

The treatment of diabetic patients with pyonecrotic lesions in the lower extremities requires prolonged reflexo-segmental balneophysiotherapy to normalize functions of the nerve centres. Curative volcanic mud solutions (15-24 g/l) enriched with organic and nonorganic biologically active compounds from volcanic deposits in Azerbaijan were used for the first time to treat such patients. Peloids were applied to the lumbar region (location of sympathetic nerve nodes) and the lower legs above and beneath the affected sites. The patients were subjected to 12-15 seances of peloidotherapy (at 40-41 degrees Celsius) each lasting 20-30 minutes. The treatment was preceded by wound sanation using the standard procedure and a course of antibiotic therapy based on individual antibiotocograms. A total of 86 daibetic patients with leg gangrene underwent rheovasographic thermovision examination that revealed enhanced blood supply to the affected extremities under the action of the applied peloids. Peloidotherapy resulted in the normalization of blood and urine glucose levels in 53 (63%) of the patients. Simultaneously, the doses of medicamentous therapy could be lowered. Wound and ulcer healing was completed in the majority of the patients (86%) by the end of balneophysiotherapy when fresh granulation tissue began to develop and signs of oedema to disappear. These patients no longer needed amputation.

An estimated 15% of patients with diabetes will develop a foot ulcer sometime in their life, making them 30 to 40 times more likely to undergo amputation due to a non-healing foot ulcer than the non-diabetic population. To determine the safety and efficacy of a new, non-contact, kilohertz ultrasound therapy for the healing of recalcitrant diabetic foot ulcers - as well as to evaluate the impact on total closure and quantitative bacterial cultures and the effect on healing of various levels of sharp/surgical debridement - a randomized, double-blinded, sham-controlled, multicenter study was conducted in hospital-based and private wound care clinics. Patients (55 met criteria for efficacy analysis) received standard of care, which included products that provide a moist environment, offloading diabetic shoes and socks, debridement, wound evaluation, and measurement. The "therapy" was either active 40 KHz ultrasound delivered by a saline mist or a "sham device" which delivered a saline mist without the use of ultrasound. After 12 weeks of care, the proportion of wounds healed (defined as complete epithelialization without drainage) in the active ultrasound therapy device group was significantly higher than that in the sham control group (40.7% versus 14.3%, P = 0.0366, Fisher's exact test). The ultrasound treatment was easy to use and no difference in the number and type of adverse events between the two treatment groups was noted. Of interest, wounds were debrided at baseline followed by a quantitative culture biopsy. The results of these cultures demonstrated a significant bioburden (greater than 10(5)) in the majority of cases, despite a lack of clinical signs of infection. Compared to control, this therapeutic modality was found to increase the healing rate of recalcitrant, diabetic foot ulcers.