A multicentre,randomised controlled clinical trial evaluating the effects of a novel autologous,heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Interim analysis

We desired to carefully evaluate a novel autologous heterogeneous skin construct in a prospective randomised clinical trial comparing this to a standard-of-care treatment in diabetic foot ulcers (DFUs). This study reports the interim analysis after the first half of the subjects have been analysed. Fifty patients (25 per group) with Wagner 1 ulcers were enrolled at 13 wound centres in the United States. Twenty-three subjects underwent the autologous heterogeneous skin construct harvest and application procedure once; two subjects required two applications due to loss of the first application. The primary endpoint was the proportion of wounds closed at 12 weeks. There were significantly more wounds closed in the treatment group (18/25; 72%) vs controls (8/25; 32%) at 12 weeks. The treatment group achieved significantly greater percent area reduction compared to the control group at every prespecified timepoint of 4, 6, 8, and 12 weeks. Thirty-eight adverse events occurred in 11 subjects (44%) in the treatment group vs 48 in 14 controls (56%), 6 of which required study removal. In the treatment group, there were no serious adverse events related to the index ulcer. Two adverse events (index ulcer cellulitis and bleeding) were possibly related to the autologous heterogeneous skin construct. Data from this planned interim analysis support that application of autologous heterogeneous skin construct may be potentially effective therapy for DFUs and provide supportive data to complete the planned study.     

糖尿病足发病风险筛查和评估的最佳证据总结

目的 总结糖尿病足发病风险筛查和评估的最佳证据。方法 检索国内外相关数据库和专业团体网站中有关糖尿病足发病风险筛查和评估的证据,包括指南、证据总结、推荐实践和系统评价。检索时限为建库至2020年1月5日。应用临床指南研究与评价系统、系统评价评估工具、JBI证据预分级及证据推荐级别系统对文献进行质量评价和证据等级评定。结果 共纳入9篇文献,包括5篇指南、1篇证据总结、1篇推荐实践和2篇系统评价。从全面采集健康史,周围神经病变的风险筛查和评估,末梢血管病变的风险筛查和评估,足部皮肤检查,足部压力的测量、足部畸形和鞋类的检查,风险分层系统的应用,风险筛查和评估的频率7个方面总结21条最佳证据。结论 最佳证据总结为临床开展规范化的糖尿病足发病风险筛查和评估提供了循证依据,医护人员应结合临床环境与患者特点,合理地应用证据。     

胫骨横向骨搬移对血清血管生成相关因子表达的影响

目的探讨胫骨横向骨搬移术对糖尿病足患者血清中血管生成相关因子表达的影响。方法回顾分析2018年1月-12月收治的10例Wagner 4期糖尿病足患者临床资料,男5例,女5例;年龄51~70岁,平均59.2岁。糖尿病病程2~60个月,平均24.2个月;糖尿病足病程30~120 d,平均54.1 d。分别于术前1 d及术后1、4、11、18、28、35 d抽取外周静脉血,离心取血清采用ELISA法检测血管生成相关因子VEGF、bFGF、EGF、PDGF的表达水平。结果患者血清VEGF、bFGF及EGF表达水平均在术后11 d突然升高,11、18、28、35 d各因子表达水平均显著高于术前,差异有统计学意义(P<0.05);PDGF表达水平于术后18 d突然升高,18、28、35 d PDGF表达水平显著高于术前,差异有统计学意义(P<0.05)。结论胫骨横向骨搬移术治疗糖尿病足,早期可显著增加血清血管生成相关因子的表达,可能是其促进糖尿病足创面愈合的作用机制。     

A systematic review investigating the identification,causes, and outcomes of delays in the management of chronic limb-threatening ischemia and diabetic foot ulceration

ObjectivePatients presenting with chronic limb-threatening ischemia and diabetic foot ulceration (DFU) are at high risk of major lower limb amputation. Long-standing concern exists regarding late presentation and delayed management contributing to increased amputation rates. Despite multiple guidelines existing on the management of both conditions, there is currently no accepted time frame in which to enact specialist care and treatment. This systematic review aimed to investigate potential time delays in the identification, referral, and management of both chronic limb-threatening ischemia and DFU.MethodsA systematic review conforming to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement standards was performed searching MEDLINE, Embase, The Cochrane Library, and Cumulative Index to Nursing and Allied Health Literature from inception to November 14, 2018. All English-language qualitative and quantitative articles investigating or reporting the identification, causes, and outcomes of time delays within “high-income” countries (annual gross domestic product per person >$15,000) were included. Data were extracted independently by the investigators. Given the clinical crossover, both conditions were investigated together. A study protocol was designed and registered at the International Prospective Register of Systematic Reviews.ResultsA total of 4780 articles were screened, of which 32 articles, involving 71,310 patients and 1388 health care professionals, were included. Twenty-three articles focused predominantly on DFU. Considerable heterogeneity was noted, and only 12 articles were deemed of high quality. Only four articles defined a delay, but this was not consistent between studies. Median times from symptom onset to specialist health care assessment ranged from 15 to 126 days, with subsequent median times from assessment to treatment ranging from 1 to 91 days. A number of patient and health care factors were consistently reported as potentially causative, including poor symptom recognition by the patient, inaccurate health care assessment, and difficulties in accessing specialist services. Twenty articles reported outcomes of delays, namely, rates of major amputation, ulcer healing, and all-cause mortality. Although results were heterogeneous, they allude to delays being associated with detrimental outcomes for patients.ConclusionsTime delays exist in all aspects of the management pathway, which are in some cases considerable in length. The causes of these are complex but reflect poor patient health-seeking behaviors, inaccurate health care assessment, and barriers to referral and treatment within the care pathway. The adoption of standardized limits for referral and treatment times, exploration of missed opportunities for diagnosis, and investigation of novel strategies for providing specialist care are required to help reduce delays.     

Inter-segmental foot kinematics during gait in elderly females according to the severity of hallux valgus

The objective of this study was to find the effect of hallux valgus (HV) deformity on the inter-segmental motion of the foot using an MFM with a 15-marker set (DuPont Foot Model, DuFM) in comparison with age and sex controlled healthy adults. Fifty-eight female symptomatic HV patients and 50 female asymptomatic older female volunteers were included in this study. According to the radiographic hallux valgus angle (HVA), the study population was divided into severe HV (SHV, HVA ≥ 40°, n = 25), moderate HV (MHV, 20° ≤ HVA < 40°, n = 47), and control (CON, n = 36). MHV group was divided into symptomatic MHV group (S-MHV, n = 33) and asymptomatic MHV group (A-MHV, n = 14) according to the symptoms associated with HV. For temporal parameters, gait speed and stride length were diminished according to the severity of HV deformity. Sagittal range of motion of hallux and hindfoot decreased significantly in SHV group. Loss of push-off during the preswing phase was observed and forefoot adduction motion during terminal stance was decreased in SHV group. In a subgroup analysis of MHV, asymptomatic HV minimally affects gait and inter-segmental motion during gait. HV deformity affects gait parameters and inter-segmental motion of the foot during gait in proportion to the severity of the deformity. However, the effect of MHV itself on foot kinematics might be limited while pain or arthritic change of the joint might cause changes in gait in patients with symptomatic HV.     

The Treatment of Posterior Tibial Tendon Insufficiency Using the Double Heel Osteotomy and Soft Tissue Reconstruction: The “All-American Procedure”

BackgroundMultiple treatment options have been proposed for the treatment of flexible (stage II) flatfoot with posterior tibial tendon insufficiency (PTTI). This article describes the rationale and technique of our joint-sparing approach to this problem with a combination of osteotomies and soft tissue reconstruction.MethodsLengthening of the lateral column (LCL) through the anterior calcaneal process diminishes the abduction of the forefoot related to the hindfoot, plantarflexes the first ray by tightening the peroneus longus tendon, and causes the arch to rise. Hindfoot valgus is addressed with a medializing calcaneal osteotomy (MCO). Additional soft tissue procedures include transfer of the flexor digitorum longus tendon (FDL), substituting for the diseased posterior tibial tendon and a percutaneous heel cord lengthening (HCL).Results and ConclusionsThe combination of a double heel osteotomy (LCL and MCO) and a soft tissue reconstruction (FDL transfer and HCL) has proven to be an excellent operation for supple PTTI in our practice for 25 years in approximately 1000 patients. Paying careful attention to the described details of the LCL portion of the procedure improves the results of the reconstruction. Removal of the LCL screw and any remaining osteophytes at the calcaneocuboid joint seems to solve the problem of lateral column pain and some overcorrection after the initial procedure.     

Posterolateral plate fixation with Pantalarlock® is more stable than nail fixation in tibiotalocalcaneal arthrodesis in a biomechanical cadaver study

BackgroundDespite the promising results of ankle joint arthroplasty, the tibiotalocalcaneal (TTC) arthrodesis remains an established procedure in treatment of combined pathology of the ankle and subtalar joint. Despite the promising results in biomechanical investigations, nonunion rates of up to 24% are described in recent studies. The objective of this work was a comparative study of the biomechanical properties of the posterolateral plate fixation with retrograde intramedullary nail fixation.MethodsTwenty four fresh-frozen human lower leg specimens (12 pairs) were used for the comparative biomechanical testing. Every specimen was preconditioned with 100 N over 200 cycles. After every 250 cycles the force was increased by 50 N from 200 to 600 N. This was followed by cyclic loading in dorsi-/plantiflexion with 800 N for 3000 cycles. All specimens were subjected to bone densitometry (DXA) and computed tomography.ResultsSignificantly higher number of spacimens with nails (4) failed during the cycling testing in dorsi-/plantarflexion and futher two during the cyclic testing with 800 N. Two specimens with plates failed during the cyclic testing with 800 N. Statistical analysis showed that the specimens with the plate were significantly more stable in each test direction. The Pearson correlation demonstrated for the specimens with plate a linear relationship between the stiffness and the determined bone density.ConclusionsThe results demonstrate a significantly superior stiffness of the Pantalarlock®-plate in all testing directions compared with the HAN nail. Probably the position of the plate on the tension side of the joint and the combination of locking and lag screws provide the higher stiffness of the plate system. The correlation of the stiffness with bone density leads to more predictable results of the plate arthrodesis. We hope for a reduction of the pseudarthrosis rate and shorten the postoperative treatment phase. The authors expect advantages in the treatment of high risk patients with severe deformity of the ankle, bone defects, neuropathic deformity, poor bone quality and osteoporosis.     

Gait changes in persons with diabetes: Early risk marker for diabetic foot ulcer

Background Increasing prevalence of diabetic foot ulcer (DFU) and subsequent foot amputation in persons with type 2 diabetic neuropathy is a well known fact. The present study was aimed to identify the initial risk marker for DFU.Methods Dynamic plantar pressure analysis was done for persons with type 2 diabetes mellitus (T2DM) without neuropathy (D), patients with diabetic neuropathy (DN) with normal foot profile and healthy persons with normal foot profile (C).Results The data showed a significant difference in dynamic peak plantar pressure between C and DN (P = 0.035) and no significant difference between D and DN (P = 0.997). The dynamic segmental peak plantar pressure results showed significant difference only in the medial heel region (P = 0.009) among the three groups.Conclusions Gait variations and restrictions in subtalar and first metatarsophalangeal joint are found in persons with diabetic neuropathy even before the onset of foot deformity.