Neuropathic Ulcers Research Articles

Healing of Neuropathic Diabetic Foot Ulcers of PEDIS Grade 1-2 at Home Care with Topical Antiseptics: An Observational Follow-Up Investigation

Objective: This observational and clinical prospective follow-up study examined the healing of ordinary diabetic foot ulcers at home-care setting with two commercially available topical antiseptics, one in formulation as a solution and the other one as a salve. Method: The study population consisted of 35 consecutive adult outpatients with diabetic foot ulcers that were classified as grades 1-2 by using the PEDIS (Perfusion, Extent, Depth, Infection and Sensation) classification system. The patients were treated by two commercial antiseptics (Abilar® 10% Resin Salve or Octenidine® solution) and followed-up by a specialized clinic with four follow-up visits during a treatment period of 145 days on average. All patients performed the wound care at home after instructions from the clinic. Results: At study entry, the mean ulcer area was 221 mm2 (median 140 mm2, interquartile range: 73-320 mm2) in the salve group and 277 mm2 (median 132 mm2, interquartile range: 50–365 mm2) in the solution group. In intentto- treat (ITT) analysis of the whole study population of 35 patients, the ulcers healed totally in 14 (37%; 95% CI 24-56%), and in 9 of 19 patients (47%; 95% CI: 25%-77%) and in 5 of 16 patients (31%; 95% CI: 9%-54%) in the resin salve and Octenidine solution groups, respectively (P>0.05). The infected ulcer with small median size showed an insignificant trend to heal better than the other ulcers. The number of positive bacterial cultures from ulcers (bacteria of Staphylococcus and Streptococcus species in great majority of cases), taken on clinical grounds if infection was suspected, was lower in follow-up visits than at study entry. No side effects were observed. Conclusion: Treatment of diabetic foot ulcers of PEDIS grade 1-2 at home-care with topical antiseptics is an option that results in complete healing of ulcer in more than one third of cases in a 145-day treatment period.

Use of Transcutaneous Application of CO2 in Diabetic Foot Pathology

In neuropathic foot ulcers, the most prominent finding is the loss of peripheral sensation and is typically seen in diabetic patients. In addition, vasculopathy may lead to foot ulcerations in diabetic patients. CO2 therapy was found to improve chronic wound healing in patients with vascular impairment. It refers to the transcutaneous and subcutaneous application of CO2 as well as CO2 water baths for therapeutic purpose. In the method used, gaseous CO2 is applied transcutaneously using the PVR system®. CO2 is applied by means of a single-use, low-density polyethylene bag which is wrapped around the leg being treated and secured with an elastic strap. The advantages of this method, compared to injecting CO2 into subcutaneous tissue, are non-invasiveness, the absence of pain and protection against infection. Compared to CO2 balneotherapy this approach enables the use of higher CO2 concentrations, application to chronic wound patients and, with appropriate precautionary measures, prevents the increase of CO2 in the surrounding air. Finzgar et al. observed that the transcutaneous application of gaseous CO2 caused a significant increase in the Laser Doppler (LD) flux in cutaneous microcirculation in vivo in humans. The favourable clinical and microcirculatory effects of gaseous CO2 have further been observed in studies of patients with intermittent claudication as well as patients with primary and secondary Raynaud's phenomenon. The reviewed studies suggest that the increased delivery of CO2 to the ulcerated area will cause vasodilation and an increase in blood flow. The improved angiogenesis and oxygenation will result in healing of the chronic wound. This principle may be applied in the treatment of diabetic foot ulceration. Moreover, the effect on blood flow may also be important in preventive and curative treatment of patients with impaired mobility due to organic or functional causes. Further work is needed for the development of therapeutic strategies to optimize CO2 use in diabetic foot patients.

Prevalence of Pressure Ulcer and Nutritional Factors Affecting Wound Closure Success in Thailand.

Introduction:The authors aimed to estimate the prevalence of pressure ulcers and to explore the nutritional effects of the prognostic factors on successful pressure ulcer closure in a public tertiary care hospital in Thailand.Patients and Methods:The study was a retrospective cohort analysis of seven-year census (2008 - 2014) at Surin hospital in Thailand. There were 424 of total 240,826 patients aged over than 15 years admitted to surgery, orthopedics and medicine wards during the study period with documented pressure ulcers (ICD 10TM). We analyzed four hundred and ten patients after excluding 14 patients with non-pressure ulcers (due to burning/ diabetic/ ischemic neuropathic ulcers, and less than 24 hours of admission) and loss medical record. We selected independent factors from demographic data, nutritional factors, pressure ulcer characteristics, and management data. The outcome of interest was successful pressure ulcer closure. The analysis method was the semi-parametric Cox regression model and reported as Hazard Ratios (HR) with 95% confidence interval (95% CI).Results:The total hospital admission was 240,826 patients between 2008 - 2014. 410 patients were developing pressure ulcers, of these, 7% (28/410) success in ulcer closure, and 77% (314/410) failure in closure requiring for additional procedures (excisional debridement). The rest of patients (16%, 68/410) was non-operative care. The prevalence of pressure ulcers was 1.7 per 1,000 person-year. The multivariable model found that only the Nottingham Hospital Screening Tool (NS) score was a statistically significant nutritional variable, and additional subgroup analysis of two models of sepsis and spinal cord co-morbidities was also significant. Adjusted hazard ratios (HR) for NS score = 0.355 (95% CI: 0.187, 0.674), p=0.002), for sepsis = 0.312 (95% CI: 0.140, 0.695), p=0.004), and for spinal cord co-morbidity = 0.420 (95% CI: 0.184, 0.958), p=0.039).Conclusions:The annual prevalence was 1.7 per 1,000 persons. NS score was strongly associated with ulcer closure success.

Nerve decompression and neuropathy complications in diabetes: Are attitudes discordant with evidence?

ABSTRACTExternal neurolysis of the nerve at fibro-osseous tunnels has been proprosed to treat or prevent signs, symptoms, and complications in the lower extremity of diabetes patients with sensorimotor polyneuropathy. Nerve decompression is justified in the presence of symptomatic compressed nerves in the several fibro-osseous tunnels of the extremities, which are known to be frequent in diabetes. Quite a body of literature has accumulated reporting results after such nerve decompression in the leg, describing pain relief and sensibility improvement, as well as balance recovery, diabetic foot ulcer prevention, curtailed ulcer recurrence risk, and amputation avoidance.Historical academic hesitance to endorse surgical treatments for pain and numbness in diabetes was based primarily on the early retrospective reports’ potential for bias and placebo effects, and that the hypothetical basis for surgery lies outside the traditional etiology paradigm of length-dependent axonopathy. This reticence is here critiqued in view of recent studies using objective, measured outcome protocols which nullify such potential confounders. Pain relief is now confirmed with Level 1 studies, and Level 2 prospective information suggests protection from initial diabetic foot ulceration and most neuropathic ulcer recurrences. In view of the potential for nerve decompression to be useful in addressing some of the more difficult, expensive, and life altering complications of diabetic neuropathy, this secondary compression thesis and operative treatment methodology may deserve reassessment.

Successful Repair of Diabetic Foot Ulcer with Honey-Based Treatment: A Case Report

Introduction: As a common diabetic complication, foot ulcers may cause a huge burden both on the patient and healthcare system. The current study aims at investigating the effectiveness of honey dressing in the presence or absence of olive oil in diabetic foot ulcer. Case Presentation: The study attempted to report a 70-year-old female with the history of diabetes undergoing high doses of oral antidiabetes drugs (OADs). Following a car accident, she developed a neuropathic ulcer categorized as Wagner grade-II. The case was admitted in Imam Reza General hospital, Mashhad, Iran in August 2014. A combined regimen of cephalexin, cefixime and anti-inflammatory drugs was started after hospitalization. Since granulation formation and tissue repair did not occur, honey dressing with and without olive oil was used to repair the ulcer. The whole treatment period lasted a month. Conclusions: To sum up, honey dressing with and without olive oil could successfully prevent the risk of amputation in case of diabetic foot ulcers.

Identification of high-risk groups of charcot foot in the people with diabetic foot neuropathic ulcerations

Objective To identify high-risk groups of Charcot foot(CN) in the people with diabetic foot neuropathic ulcerations(NU). Methods Twenty cases patients with CN who were diagnosed in General Hospital of the Chinese People Air Force from June 2008 to June 2013 and 58 patients with diabetic neuropathic ulcer who were hospitalized from January 2010 to December 2011 and followed up until June 2014 without foot deformity were retrospectively analyzed.All patient's general condition, examination and laboratory results, diabetic chronic complications, complication, diabetes distribution of foot ulcers, and plain features. Results There were no statistically significant differences in terms of patients' average age, sex ratio, proportion of smokers, BMI, HbA1c, blood lipid, dorsalis pedis artery diameter and diabetic nephropathy (Ⅲ-Ⅳ period), chronic kidney disease stage 3 above, proliferation diabetic retinal pathological changes, the prevalence of coronary heart disease between the two groups(P>0.05). Compared with NU group, patients with single high proportion(40.00%(8/20) vs.10.34%(6/58)), Short duration of diabetes((12.37±5.64) years vs.(14.27±8.04) years), Feet long numbness(6(5, 9) years vs.4(2, 20) years), low rate of hardening of the arteries narrow(ABI<0.9)( 0(0/20) vs.39.66%(13/58)), high recurrent diabetic foot ulcer prevalence(70.00%(14/20) vs.25.86%(15/58)), more patients with diabetes mellitus autonomic neuropathy(75.00%(15/20) vs.39.66%(23/58)), less combined with hypertension(25.00%(5/20) vs.58.62%(34/58)), the differences were significant(t orχ2=6.981, 2.259, 4.068, 3.887, 12.405, 7.436, 6.724; P<0.05). Diabetic foot wound distribution on mesopodium of CN group and NU group was 36.84%(7/19), 6.90%(4/58) respectively, the difference was significant(χ2=11.443, P=0.003). Diabetic foot amputation rate(Wanger 4, 5 grade) of CN group and NU group was 44.44%(4/9), 6.90%(2/29) respectively, the difference was significant(χ2=4.732, P=0.020). Conclusion The characteristics of high-risk groups of diabetics Charcot foot in the people with diabetic foot neuropathic ulcerations are middle aged, no foot of ischemia, combine the diabetic autonomic neuropathy and the feet always with recurrent ulcers. Key words: Diabetic foot ulcer; Diabetic peripheral neuropathy; Neuropathic ulcer; Charcot foot

The Effectiveness of Three Layers Foam Dressing as an Offloading Technique in Treating Diabetic Foot Ulcer : Comparative Study

Background and aim of the work: and aim of the work: More than 25% of Saudi Arabia population are diabetics, about 20% of the will develop ulcer in their feet. Offloading is the cornerstone in prevention or healing of plantar neuropathic foot ulcers. This study aimed to investigate the effectiveness of use of three layers elastic foam as an off-loading modality in patients with diabetic non infected neuropathic ulcers in term of the speed of healing progress and comparing that with removable walking boat off-loading techniques. Patients and methods: this prospective double-blind, randomized, controlled clinical trialwas done in diabetic foot care clinics at King Abdul Aziz specialist Hospital, King Faisal general Hospital and Prince Mansour military Hospital, Taif, Saudi Arabia from January 2014 to October 2016.Diabetic patients with non infected neuropathic plantar ulcers after debridement of at least 2 weeks were included in the study. Ischemic ulcers are excluded from the study. Patients who met the inclusion criteria of this study weresubdevided randomized into 2 groups, the felted foam dressings group; in which the three layers felted foam was applied around the ulcer. Control group the removable walking boat was used. In both groups the ulcer was covered with saline soaked dressing to be changed daily. Results:47 patients were enrolled in the study (23 in felted foam group and 24 in the removable walking boat group). There was no significant difference in the demographics, ulcer size, duration of diabetes, and clinical and laboratory data between both groups (P > 0.05). The mean duration of complete healing of the ulcer was highly significantly shorter in felted foam group than in the removable walking boat group (P < 0.001). In both groups the duration of healing was negatively correlated with the patient age, the level of HbA1c,andthe ulcer size (P < 0.05). Conclusions: the three layers felted foam is effective, simple, and less expensive offloading technique and it superior to removable walking boat in promoting the complete healing of neuropathic diabetic foot ulcers.

P10 Investigating the wound healing capacity of outgrowth endothelial cells from diabetic neuropathy and neuroischaemia patients

Endothelial dysfunction and inflammation are the most important parameters in the pathogenesis of diabetes, and these processes underpin the development of diabetic foot ulcers. Outgrowth endothelial cells (OECs) have therapeutic potential for diabetic wounds because of their ability to proliferate, migrate and promote angiogenesis. However, the precise mechanisms supporting their differentiation capacity, physiological roles and homing to sites of injury remain to be elucidated. This study aims to establish the function of OECs from diabetic patients with neuroischaemic and neuropathic ulcers, and determine their potential role in wound healing. Healthy volunteer subjects provide OECs as comparative control cells. Migration of CD34+ OECs, evaluated by a scratch assay, demonstrated that migration is impaired in neuropathic OECs compared to healthy control and neuroischaemic OECs. An angiogenesis tube formation assay also established a lack of capacity and reduced capacity of the neuropathic and neuroischaemic OECs respectively to form an endothelial network, compared to healthy OECs measured using the closed loop perimeter, and the number of branch points. Nitrite concentrations measured using a Griess assay, showed that diabetic OECs produced less nitric oxide as compared to healthy OECs. Cytokine analysis of patient serum and OEC supernatant using Bioplex suspension array technology has also been carried out, to determine any correlation between OEC function, the inflammatory and angiogenic profile of the patient. These data are under analysis and will be presented. Understanding these parameters could have great clinical impact in the development of novel wound healing therapies among diabetic patients to reduce ongoing complications.

The effectiveness of felt padding for offloading diabetes-related foot ulcers, at baseline and after one week of wear

AimFelt padding is used to offload diabetes-related foot ulceration although limited quality data exists to support its use. This study aimed to quantify pressure offloading from neuropathic plantar foot ulcers in a clinical setting, when felt padding is first applied and after wear. MethodsThis study used a within-subjects, repeated measures design. Data was collected in a high-risk foot service. Peak plantar pressures, contact area and contact time were measured in 15 diabetes subjects with 16 non-complicated plantar neuropathic foot ulcers, with: no felt padding, newly applied felt padding and felt padding after one week of wear. ResultsStatistically significant decreases in peak pressure of 49% and 32% were measured with newly applied felt padding (188.0kPa; p<0.001) and worn felt padding (248kPa; p=0.003) respectively, compared to no padding (367.2kPa). Worn felt offloaded 32% less pressure than new felt however this did not reach statistical significance (p=.069). Corresponding increases in contact area of 18% and 14% occurred with newly applied felt padding (156.9cm2; p<.001) and worn felt padding (150.6cm2; p=0.003) compared to no padding (132.5cm2). Contact time was constant across testing conditions. ConclusionsNew felt padding offloaded on average half the pressure applied to sites of plantar neuropathic ulceration, which reduced to one third after wear. Increased contact area under the foot is a possible mechanism contributing to pressure reduction. Further studies are required to evaluate effectiveness of felt padding directly on ulcer healing.

The Role of Pressure Offloading on Diabetic Foot Ulcer Healing and Prevention of Recurrence.

An increased plantar pressure is a causative factor in the development of plantar foot ulcers in people with diabetes mellitus, and ulcers are a precursor of lower extremity amputation. In this article, the evidence is reviewed that relieving areas of increased plantar pressure (ie, offloading) can heal plantar foot ulcers and prevent their recurrence. Noninfected, nonischemic neuropathic plantar forefoot ulcers should heal in 6 to 8 weeks with adequate offloading. Recent meta-analyses and systematic reviews show that nonremovable knee-high devices are most effective. This is probably because they eliminate the problem of nonadherence with the use of a removable device. Studies show a large discrepancy between evidence-based recommendations on offloading and what is used in clinical practice. Many clinics continue to use methods that are less effective or have not been proven to be effective, while ignoring evidence-based methods. Strategies are proposed to address this issue, notably the adoption and implementation of recent international guidelines by professional societies and a stronger focus of clinicians on expedited healing. For the prevention of plantar foot ulcer recurrence in high-risk patients, 2 recent trials have shown that the incidence of recurrence can be significantly reduced with custom-made footwear that has a demonstrated pressure-relieving effect through guidance by plantar pressure measurements, under the condition that the footwear is worn. This review helps to inform clinicians about effective offloading treatment for healing plantar foot ulcers and preventing their recurrence.

Gastrocnemius fascia release under local anaesthesia as a treatment for neuropathic foot ulcers in diabetic patients: a short series

Background: Diabetic foot ulceration is the leading cause of major amputation in the developed world. Plantar neuropathic ulcers at the forefoot can be managed conservatively with off-loading, but treatment is not invariably successful. Achilles tendon lengthening procedures aim at increasing dorsiflexion and decreasing forefoot pressure but can be associated with complications and require prolonged postoperative immobilization to prevent tendon rupture. We assessed the feasibility and clinical outcome of a comparative minimal invasive procedure: the gastrocnemius fascia release. This technique targets the same goals but is performed under local anaesthesia and allows immediate postoperative weight bearing and ambulation.Methods: Diabetic patients with plantar neuropathic ulcers Wagner grade 2 or 3 were recruited from our diabetic foot clinic. Patients with infected wounds or untreatable peripheral arterial disease were excluded from the study. Conservative treatment with off-loading and local wound care was attempted for six weeks and surgical procedure only contemplated upon failure. Primary end-points were improved range of dorsiflexion and time to healing. Secondary end-points were local ulcer recurrences, new plantar ulcers, and minor or major amputation. Post-operative follow-up was 12 months.Results: Seven patients were included in the study. An improvement in dorsiflexion of 10.4° (mean) was recorded post-operatively (p < 0.01). After 30 days, complete healing was accomplished in six of the seven patients. Long-term results were excellent as no ulcer recurrence or amputation was noted.Conclusions: Gastrocnemius fascia release under local anaesthesia can be performed safely in diabetic patients with plantar neuropathic ulcers under the metatarsal heads. Clinical outcome is excellent and long-term results promising.

Prospective, Randomized, Controlled, Comparative Effectiveness Trial Examining Healing, of Acellular-Reticular Human-Dermis Versus Standard Care in Treatment of Diabetic Foot Ulcers

Category: Diabetes Introduction/Purpose: One sequitur of prolonged diabetes is the development of diabetic foot ulcers (DFUs), which are often complicated by lower extremity amputation (LEA). The annual incidence of DFUs and LEAs calculated from the Medicare population is approximately 6% and 0.4% respectively. Many acellular dermal matrices have been shown to successfully heal these wounds. In this study, we examined a novel, human, acellular reticular dermis with an open, porous, uniform framework aseptically processed to retain endogenous matrix protein versus standard of care in non healing diabetic foot wounds. Methods: This study was a multicenter, randomized controlled trial in which diabetic patients having at least one non-healing neuropathic foot ulcer that failed at least 4 weeks of documented conservative care with adequate blood flow and a lack of renal failure were screened for a 2-week period. Those meeting inclusion and exclusion criteria, after 2-weeks of offloading and moist wound care if the diabetic foot ulcer (DFU) failed to reduce in area by 20% were randomized 1:1 to standard of care (SOC) or human acellular dermal tissue (HADT) applied weekly plus SOC for up to 12 weeks Results: At 6 weeks, 65% of the HADT–treated wounds had healed (13/20) compared to 5% (1/20) of the wounds that received SOC alone (adjusted p=.00028). At 12 weeks, 80% of the HADT–treated wounds (16/20) had healed compared to 20% (4/20) of the DFUs in the SOC group (adjusted p=.00036). Mean time to heal within 12 weeks was 39.6 days for the HADT group compared to 77.0 days for the SOC group (adjusted p=.00014). There was no incidence of increased adverse or serious adverse events between groups, nor adverse events related to the graft. The mean and median costs to closure in the HADT group were $1475.00 and $963.00, respectively, per healed wound Conclusion: These findings demonstrate that weekly application of acellular human reticular dermis is an effective treatment for non-healing diabetic foot wounds. Wound-size-specific pieces may allow for decreased cost to closure and wastage.

Cost-Effectiveness Analysis of d-Nav for People with Diabetes at High Risk of Neuropathic Foot Ulcers.

IntroductionThe objective of this study was to assess the cost-effectiveness of the d-Nav Insulin Guidance Service (Hygieia Inc.), a system designed to improve glycemic control via the use of insulin titration, in people with diabetes at risk of developing neuropathic foot ulcers.MethodsA Markov model containing four health states (no ulcer, uninfected ulcer, infected ulcer, and amputation) was developed to compare d-Nav with current National Health Service standard care. Patient movement between the health states was governed by event rates taken from the wider literature. Both the healing rate for uninfected ulcers and the rate of recurrence for uninfected ulcers were directly influenced by the patient’s glycated hemoglobin (HbA1c). Separate mean HbA1c values were assigned to treatment and control patients and taken from a single-arm study that examined the effect of d-Nav on the outcomes of 122 patients, with HbA1c for control patients based on values recorded in the 12-month period prior to the study and HbA1c for d-Nav based on values recorded during the trial. Weekly cycles were applied, and patient resource use and quality-adjusted life years (QALYs) were estimated over a 3-year time horizon. Univariate sensitivity analysis was undertaken.ResultsIn the base case, d-Nav was cost-saving and produced more QALYs than standard care, with a total net monetary benefit value of £1459 per patient. Univariate analysis indicated that the model results are relatively robust to variations in underlying parameters, with patient HbA1c having the most significant impact on outcomes.ConclusionInterventions that aim to improve glycemic control, such as d-Nav, appear to be a cost-effective use of healthcare resources when targeted at those with poor glycemic control at high risk of developing foot ulcers.FundingHygieia Inc.

Evaluation of tissue engineering products for the management of neuropathic diabetic foot ulcers: an interim analysis.

The objective of this prospective, multicentre clinical study is to assess the application of MatriStem MicroMatrix (MSMM) and MatriStem Wound Matrix (MSWM) (porcine urinary bladder derived extracellular matrix) compared with Dermagraft (DG) (human fibroblast-derived dermal substitute) for the management of non-healing diabetic foot ulcers (DFUs). A randomised, multicentre study was conducted at thirteen centers throughout the US. It was designed to evaluate the incidence of ulcer closure, rate of ulcer healing, wound characteristics, patient quality of life, cost-effectiveness, and recurrence. Those subjects whose DFUs decreased in size by ≤30% or increased by ≤50% during the standard of care (SOC) phase were randomised into the treatment phase of the study. The study evaluated complete wound closure by eight weeks with weekly device application. A two-week post treatment SOC phase followed the treatment phase for any wounds that did not heal by the end of eight weeks, and wound closure was also evaluated at the end of that period. Ulcer recurrence at 6 months post-treatment was evaluated in the subjects that showed wound healing by the end of the post-treatment SOC phase. Standard adjunctive therapy, including debridement, saline irrigation and foot off-loading, was provided to both arms during the four-week screening period, after which eligible subjects were randomised in a 1:1 ratio, to either the MatriStem (MS) or DG treatment arm. This study was developed to evaluate the hypothesis that the wound outcomes observed after wound management with MS were non-inferior to those of DG after eight weeks. The authors present the planned interim results of this study after one half of the projected enrolment was completed. There were 95 subjects consented and entered into the SOC four-week screening phase of the trial and 56 were randomised into the treatment phase. At the planned interim analysis, there was a significantly lower cost per subject and significant improvement in patient quality of life for the subjects treated with MS compared with those managed with DG. However, there was not a statistically significant difference found during the analysis of the interim data between the two study groups for rate of wound healing or number of subjects with complete wound closure. The data from this interim analysis show that MSMM and MSWM provide results for healing DFUs that are similar to the results obtained for DG at a significant quality of life and economic advantage. The opinions expressed are those of the authors and not necessarily those of the Department of Veterans Affairs or the United States Government. T.W. Gilbert is employed as the Chief Science Officer and is a stockholder in ACell, Inc., which commercializes MatriStem Wound Matrix and MicroMatrix. None of the other authors have a conflict of interest to declare.

Evaluation of tissue engineering products for the management of neuropathic diabetic foot ulcers: an interim analysis

The objective of this prospective, multicentre clinical study is to assess the application of MatriStem MicroMatrix (MSMM) and MatriStem Wound Matrix (MSWM) (porcine urinary bladder derived extracellular matrix) compared with Dermagraft (DG) (human fibroblast-derived dermal substitute) for the management of non-healing diabetic foot ulcers (DFUs). A randomised, multicentre study was conducted at thirteen centers throughout the US. It was designed to evaluate the incidence of ulcer closure, rate of ulcer healing, wound characteristics, patient quality of life, cost-effectiveness, and recurrence. Those subjects whose DFUs decreased in size by ≤30% or increased by ≤50% during the standard of care (SOC) phase were randomised into the treatment phase of the study. The study evaluated complete wound closure by eight weeks with weekly device application. A two-week post treatment SOC phase followed the treatment phase for any wounds that did not heal by the end of eight weeks, and wound closure was also evaluated at the end of that period. Ulcer recurrence at 6 months post-treatment was evaluated in the subjects that showed wound healing by the end of the post-treatment SOC phase. Standard adjunctive therapy, including debridement, saline irrigation and foot off-loading, was provided to both arms during the four-week screening period, after which eligible subjects were randomised in a 1:1 ratio, to either the MatriStem (MS) or DG treatment arm. This study was developed to evaluate the hypothesis that the wound outcomes observed after wound management with MS were non-inferior to those of DG after eight weeks. The authors present the planned interim results of this study after one half of the projected enrolment was completed. There were 95 subjects consented and entered into the SOC four-week screening phase of the trial and 56 were randomised into the treatment phase. At the planned interim analysis, there was a significantly lower cost per subject and significant improvement in patient quality of life for the subjects treated with MS compared with those managed with DG. However, there was not a statistically significant difference found during the analysis of the interim data between the two study groups for rate of wound healing or number of subjects with complete wound closure. The data from this interim analysis show that MSMM and MSWM provide results for healing DFUs that are similar to the results obtained for DG at a significant quality of life and economic advantage.

Gait parameters of people with diabetes-related neuropathic plantar foot ulcers

BackgroundFoot ulceration associated with diabetic peripheral neuropathy is a global concern. Biomechanical investigation allows the identification of gait abnormalities that may adversely affect ulcer healing. The objective of this case–control study was to compare the gait parameters of cases with diabetes-related foot ulcers to controls. MethodsThree-dimensional movement analyses were performed on 21 people with diabetes-related neuropathic plantar foot ulcers (cases), 69 people with diabetes without a foot ulcer history (diabetes controls) and 56 healthy controls. Outcome data were reported as mean differences, 95% confidence intervals and Cohen's d effect sizes. Binary logistic regressions were used to adjust for age, sex and body mass index. FindingsPeople with foot ulcers had a smaller plantar flexion (Cohen's d=−0.6 vs. diabetes controls and d=−0.8 vs. healthy controls), knee flexion (d=−0.6 vs. diabetes controls and d=−1.0 vs. healthy controls) and pelvic obliquity (d=−0.9 vs. diabetes controls and d=−0.7 vs. healthy controls) (all P<0.05). They also had a significantly greater range of anterior–posterior ground reaction force (d=1.0 vs. diabetes controls and d=1.7 vs. healthy controls) and total vertical ground reaction force (d=0.9 vs. diabetes controls and d=1.1 vs. healthy controls) and significantly slower walking speed and smaller step length compared to controls (all P<0.05). InterpretationPeople with plantar foot ulcers have considerably different gait parameters to controls. Whether the observed gait parameters contributed to the ulcer development or are a response to the ulcer is currently unclear and needs further investigation.

Septic Arthritis and Osteomyelitis

Septic arthritis is an inflammatory condition within the joint in reaction to bacterial infection in the joint space. Emergent diagnosis and initiation of therapy are necessary to prevent joint destruction and, in some cases, serious systemic illness. This review covers the epidemiology, assessment and stabilization, diagnosis, treatment and disposition, and outcomes of septic arthritis. Figures show the pathophysiology of bone infection; an algorithm for the initial evaluation and management of a suspected septic joint; a magnetic resonance image of vertebral body osteomyelitis; a cutaneous sinus in a patient with underlying chronic posttraumatic osteomyelitis at the site of a previous tibial fracture; the probe-to-bone test for diagnosing osteomyelitis in the diabetic foot; an algorithm for the initial evaluation and management of suspected vertebral body osteomyelitis; nonsurgical treatment of osteomyelitis of the foot in a patient with diabetes; and algorithms for the evaluation and management of osteomyelitis in diabetic patients with neuropathic ulcers and no or mild foot infection, osteomyelitis in diabetic patients with neuropathic ulcers and moderate or severe foot infection, and chronic posttraumatic osteomyelitis. Tables list supportive findings for diagnosis of chronic osteomyelitis, risk factors for the development of septic arthritis in patients with underlying joint disease, microbiology in septic arthritis, empirical antibiotic therapy for septic arthritis, microbiology in vertebral osteomyelitis, antibiotic therapy for vertebral osteomyelitis awaiting culture results, representative studies with likelihood ratios for diagnostic tests used in the evaluation of native joint septic arthritis, antibiotic therapy for vertebral osteomyelitis with unknown or established microbiology, and antibiotic therapy for diabetic pedal osteomyelitis with unknown or established microbiology. Key words: osteomyelitis, probe-to-bone test, septic arthritis, septic joint, vertebral osteomyelitis This review contains 10 highly rendered figures, 9 tables, and 110 references.

Relationship between diabetic neuropathy and occurrence of depression among diabetic patients.

Diabetes itself, by its nature, can aggravate the symptoms of depression. One of its main complications is peripheral diabetic neuropathy (PDN). Based on the literature the presence of the relationship between the PDN and depression is confirmed. The symptoms connected with instability while walking and reduction of everyday activities were the strongest predictors of the intensification of depression symptoms. The relationship between the neuropathic ulcers and depression is considered as ambiguous. Additional problems in diagnosis and evaluation is the polyetiologic character of the disease, damage to the nerve fibers of different thickness, variety of methods of the diagnosis and differences in the prevalence of diabetic neuropathy (26%-50%). The presence of the described differences may be connected with diagnostic methods and the fact of the modification of perceived symptoms such as pain by the depression itself. One of the results of difficulties in describing the relationships and diagnosis are problems, described in the literature, with the selection of patients requiring treatment of PDN.

A Forgotten Disease “Leprae” and Limb Lesions

Leprae, which is a forgotten infectious disease, presents with primary findings of skin lesions and peripheral nerve lesions. Neuropathic ulcers are frequently found and may cause deformities, particularly in the extremities. It should not be forgotten that malignant tumors seen on the floor of chronic ulcers can also be seen on the floor of neuropathic ulcers depending on leprae. In our study, a 61-year-old male patient with an ulcerated and unhealed lesion in the volar surface of the second finger of his right hand that existed for approximately 6 months is presented. Although leprae is not common these days, early defect repairs will prevent osteomyelitis and sequelae of amputation, depending on the malignancy in these patients.

Multidisciplinary team approach for diabetic foot patients in an out-patient clinic

To assess the effectiveness of multidisciplinary team approach in daily practice of diabetic foot. 376 diabetic patients (446 ulcers) treated in a diabetic foot department in 2014 were examined. All patients were screened for diabetic peripheral polyneuropathy and blood insufficiency of lower extremities in order to diagnose the type of diabetic foot ulcer: neuropathic or neuroischemic. Patients were treated by a multidisciplinary team. The number of healed ulcers, minor and major amputations was analyzed. 80% of diabetic foot ulcers were neuropathic with normal blood supply, 20% had signs of ischemia. 77.8% of the ulcers healed in the general group during the study period. 13 amputations (2.9%) were done in the study group: 7 minor amputations (1.6%), 2 below the knee (0.4%), and 4 above knee (0.9%). Two patients died from cardiovascular events (0.4%). The comparative analysis of outcomes of neuropathic and neuroischemic ulcers showed that 84% of neuropathic ulcers healed. Minor amputations were done in 1% of the cases, no major amputations were performed. In patients with neuroischemic ulcers, 60% of them healed, minor amputations were made in 3.4% of cases (2.3% below knee, 4.6% above knee). The majority of diabetic ulcers in the study group were neuropathic with normal blood supply. The main risk factor of major amputations is ischemia of the affected limb. The multidisciplinary team approach in daily practice of the diabetic foot department of an out-patient clinic is instrumental in healing ulcers and minimizing the risk of major amputations.