Incidence and risk factors of new foot ulcer among diabetic patients on peritoneal dialysis

Objective To study the incidence and risk factors of new foot ulcer among diabetic patients on peritoneal dialysis. Methods This is a single-center prospective cohort study. Clinically-stable diabetic patients on peritoneal dialysis in our renal division were recruited from January 2014 to June 2014. Baseline data including general information, biochemistry data, dialysis adequacy, the dorsalis pedis artery pulse, clinical symptoms of diabetic foot and ankle brachial index were recorded. All patients were followed till to Dec 31, 2015. The outcomes consisted of new foot ulcer, amputation due to foot ulcer or gangrene, and lower limb vascular blood supply revascularization. Results Totally 108 patients were recruited and followed up the average time (17.7±5.6) months. Among 108 patients, 16 cases had a history of diabetic foot ulcer, and 1 case had amputation. During the follow-up, 11 cases (10.2%) had new foot ulcer, 3 cases (2.8%) had amputation due to foot ulcers or gangrene, and 8 cases (7.4%) had lower limb vascular blood supply revascularization. A total of 13 cases (12%) had composite end points with 81.3 times/1000 patients of incidence. Univariate and multivariate Cox regression models showed that the history of foot ulcer was the only independent risk factors for new foot ulcers-related composite end points. Conclusion The incidence of new foot ulcer-related composite end points was 12%, which could be independently predicted by the history of diabetic foot ulcer.     

Epidermal growth factor intralesional infiltrations can prevent amputation in patients with advanced diabetic foot wounds

This study examined if a series of epidermal growth factor (EGF) local infiltrations can enhance the healing process of complicated diabetic wounds. Twenty-nine in-hospital patients with diabetic neuropathic or ischaemic lesions with high risk of amputation were treated in a non controlled pilot study conducted at the National Institute of Angiology, Havana. Lesions, classified as Wagner's grade 3 or 4, included ulcers > or = 20 cm2 for > or = 25 days or amputation residual bases > or = 30 cm2 for > or = 15 days, healing refractory despite comprehensive wound care. EGF (25 microg) intralesional infiltrations (approximately 250 microl of a 25 microg/ml solution/injection point) were performed thrice weekly up to the eighth week. Wound closure was monitored during the treatment and recurrence examined for a year following discharge from hospital. Eighty-six per cent of the patients treated showed a productive granulation at infiltration session 8. Histological examination at this point indicated a substantial wound matrix transformation, granulation tissue cell repopulation and angiogenesis. Of the 29 patients treated, amputation was prevented in 17 (58.6%) of them who completed 24 infiltration sessions. They averaged 71.1 +/- 18.3% of reepithelisation during a mean in-hospital period of 66.5 +/- 4.9 days. Wound recurrence after 1 year of follow-up appeared in only one patient. Preliminary evidences suggest that EGF intralesional infiltrations may be effective in reducing diabetic lower limb amputation.     

The impact of gender on diabetes-related lower extremity amputations: An Italian regional analysis on trends and predictors

BackgroundDiabetes-related lower extremity amputations (LEAs) are a major public health issue. The aim of the study was to evaluate trends by gender and predictors of LEAs in an Italian region.MethodsData were collected from hospital discharge records between 2006 and 2015. Gender- and age-adjusted standardised hospitalisation rates for major and minor amputations were calculated. Poisson regression model was performed to estimate trends in LEAs.ResultsHospitalisation rates decreased for minor amputations both among males (?30.0%) and females (?5.3%), while the major amputation rates decreased only for males (?44.7%). Males were at higher risk of undergoing major (IRR 1.41, 95%CI 1.19–1.67) and minor (IRR 1.62, 95%CI 1.45–1.82) amputations. Peripheral vascular disease was the leading predictor of major and minor amputations.ConclusionA significant reduction of LEAs was observed only for males. Identifying their predictable factors may help caregivers to provide higher standards of diabetes care.     

Resource utilization and economic costs of care based on a randomized trial of vacuum-assisted closure therapy in the treatment of diabetic foot wounds

BACKGROUND: To evaluate resource utilization and direct economic costs of care for patients treated with negative-pressure wound therapy (NPWT), using the Vacuum-Assisted Closure (V.A.C.) system, compared to standard moist wound therapy (MWT). METHODS: A total of 162 diabetic patients with post-amputation wounds (up to the trans-metatarsal level) entered a 16-week, randomized clinical trial. Patients randomized to V.A.C. (n = 77) received therapy with dressing changes every 48 hours. Control patients (n = 85) received standard MWT. Resource utilization, procedures, and direct costs were calculated and analyzed in this post hoc retrospective study. RESULTS: There was no difference between groups for in-patient hospital stay (number of admissions or length of stay). More surgical procedures (including debridement) were required in the MWT group (120 vs 43 NPWT, P <.001). The average number of dressing changes performed per patient was 118.0 (range 12-226) for MWT versus 41 (6-140) for NPWT (P = .0001). The MWT group had 11 (range 0-106) outpatient treatment visits during the study versus 4 (range 0-47) in the NPWT group (P <.05). The average direct cost per patient treated for 8 weeks or longer (independent of clinical outcome) was $27,270 and $36,096 in the NPWT and MWT groups, respectively. The average total cost to achieve healing was $25,954 for patients treated with NPWT (n = 43) compared with $38,806 for the MWT group (n = 33). CONCLUSION: Treatment of diabetic patients with post amputation wounds using NPWT resulted in lower resource utilization and a greater proportion of patients obtaining wound healing at a lower overall cost of care when compared to MWT.     

Detection and genetic characterization of foot‐and‐mouth disease viruses in samples from clinically healthy animals in endemic settings

A total of 1501 oral swab samples from Pakistan, Afghanistan and Tajikistan were collected from clinically healthy animals between July 2008 and August 2009 and assayed for the presence of foot‐and‐mouth disease virus (FMDV) RNA. The oral swab samples from two (of four) live animal markets in Pakistan (n = 245), one (of three) live animal market in Afghanistan (n = 61) and both the live animal markets in Tajikistan (n = 120) all tested negative. However, 2 of 129 (∼2%) samples from Gondal and 11 of 123 (9%) from Chichawatni markets in Pakistan were positive for FMDV RNA. Similarly, 12 of 81 (15%) samples from Kabul and 10 of 20 (50%) from Badakhshan in Afghanistan were found to be positive. Serotypes A and O of FMDV were identified within these samples. Oral swab samples were also collected from dairy colonies in Harbanspura, Lahore (n = 232) and Nagori, Karachi (n = 136), but all tested negative for FMDV. In the Landhi dairy colony, Pakistan, a cohort of 179 apparently healthy animals was studied. On their arrival within the colony, thirty‐nine (22%) of these animals were found positive for FMDV RNA (serotype A was identified), while 130 (72.6%) had antibodies to FMDV non‐structural proteins. Thus, newly introduced animals may be a significant source of the disease in the colony. Only two animals from the cohort were detected as becoming positive for FMDV RNA during a follow‐up period of 4 months; however, only 10 animals remained negative for anti‐NSP antibodies during this period.     

Treatment of chronic diabetic lower leg ulcers with activated protein C: a randomised placebo‐controlled,double‐blind pilot clinical trial

Lower leg ulcers are a serious and long‐term complication in patients with diabetes and pose a major health concern because of the increasing number of patients diagnosed with diabetes each year. This study sought to evaluate the clinical benefit of topical activated protein C (APC) on chronic lower leg ulcers in patients with diabetes. Twelve patients were randomly assigned to receive either APC (N = 6) or physiological saline (placebo; N = 6) in a randomised, placebo‐controlled, double‐blind pilot clinical trial. Treatment was administered topically, twice weekly for 6 weeks with final follow‐up at 20 weeks. Wound area was significantly reduced to 34·8 ± 16·4% of week 0 levels at 20 weeks in APC‐treated wounds (p = 0·01). At 20 weeks, three APC‐treated wounds had completely healed, compared to one saline‐treated wound. Full‐thickness wound edge skin biopsies showed reduced inflammatory cell infiltration and increased vascular proliferation following APC treatment. Patient stress scores were also significantly reduced following APC treatment (p < 0·05), demonstrating improved patient quality of life as assessed by the Cardiff Wound Impact Questionnaire. This pilot trial suggests that APC is a safe topical agent for healing chronic lower leg ulcers in patients with diabetes and provides supporting evidence for a larger clinical trial.     

The efficacy and safety of Grafix® for the treatment of chronic diabetic foot ulcers: results of a multi‐centre,controlled, randomised,blinded, clinical trial

In a randomised, controlled study, we compared the efficacy of Grafix^®, a human viable wound matrix (hVWM) (N = 50), to standard wound care (n = 47) to heal diabetic foot ulcers (DFUs). The primary endpoint was the proportion of patients with complete wound closure by 12 weeks. Secondary endpoints included the time to wound closure, adverse events and wound closure in the crossover phase. The proportion of patients who achieved complete wound closure was significantly higher in patients who received Grafix (62%) compared with controls (21%, P = 0·0001). The median time to healing was 42 days in Grafix patients compared with 69·5 days in controls (P = 0·019). There were fewer Grafix patients with adverse events (44% versus 66%, P = 0·031) and fewer Grafix patients with wound‐related infections (18% versus 36·2%, P = 0·044). Among the study subjects that healed, ulcers remained closed in 82·1% of patients (23 of 28 patients) in the Grafix group versus 70% (7 of 10 patients) in the control group (P = 0·419). Treatment with Grafix significantly improved DFU healing compared with standard wound therapy. Importantly, Grafix also reduced DFU‐related complications. The results of this well‐controlled study showed that Grafix is a safe and more effective therapy for treating DFUs than standard wound therapy.     

透析中心夜间血液透析治疗尿毒症患者的疗效及安全性分析

目的 探讨与分析透析中心夜间血液透析对尿毒症患者的临床治疗效果及安全性,评价血液透析对尿毒症患者营养状况的影响.方法 将2013年1月到2014年5月于本院接受治疗的80例尿毒症患者作为研究对象,随机将其分为对照组与观察组各40例,针对对照组给予常规血液透析治疗方案,对观察组则选用夜间血液透析治疗方案,治疗半年后,对两组患者的营养状况进行评分,并对比观察两组患者的临床治疗效果.结果 ①在完成6个月的血液透析治疗后,观察组患者在治疗后其上臂周径[(30.4±5.5)cm]显著高于治疗前期,同时显著优于对照组[(27.2±4.6)cm](t=4.326,P＜0.05),同时体重、皮褶厚度、握力等均得到不同程度的改善;②完成6个月的透析治疗,观察组患者的血液生化指标,包括血浆白蛋白、血钙等指标均有所提升,甲状旁腺激素与血磷均有所降低,其中以血磷降低更为明显,显著低于对照组,组间对比差异显著(t =6.264,P＜0.05).结论 夜间血液透析对比常规透析方式来说能够明显提升患者的营养需求量,提升治疗效果,保障治疗安全性,提高患者营养状况的目的,值得临床推广应用.     

Podiatrist care and outcomes for patients with diabetes and foot ulcer

We examined whether outcomes of care (amputation and hospitalisation) among patients with diabetes and foot ulcer differ between those who received pre‐ulcer care from podiatrists and those who did not. Adult patients with diabetes and a diagnosis of a diabetic foot ulcer were found in the MarketScan Databases, 2005–2008. Multivariate Cox proportional hazard models estimated the hazard of amputation and hospitalisation. Logistic regression estimated the likelihood of these events. Propensity score weighting and regression adjustment were used to adjust for potentially different characteristics of patients who did and did not receive podiatric care. The sample included 27 545 patients aged greater than 65+ years (Medicare‐eligible patients with employer‐sponsored supplemental insurance) and 20 208 patients aged lesser than 65 years (non Medicare‐eligible commercially insured patients). Care by podiatrists in the year prior to a diabetic foot ulcer was associated with a lower hazard of lower extremity amputation, major amputation and hospitalisations in both non Medicare‐eligible commercially insured and Medicare‐eligible patient populations. Systematic differences between patients with diabetes and foot ulcer, receiving and not receiving care from podiatrists were also observed; specifically, patients with diabetes receiving care from podiatrists tend to be older and sicker.     

Vaccination against hepatitis B in children and adolescent patients on dialysis

Twenty-one children and adolescent patients, 2-19 years of age, on renal replacement therapy were immunised at monthly intervals with three doses of 20 micrograms hepatitis B vaccine (Heptavax B, Merck Sharp & Dohme). In the absence of seroconversion, vaccination was continued with monthly doses of 40 micrograms hepatitis B vaccine until antibody to hepatitis B surface antigen became positive. The rate of seroconversion increased from 33.3% (7 of 21) to 76.1% (16 of 21) and 85.6% (18 of 21) with three, four and five vaccine injections respectively. Three patients had no immune response despite six to seven vaccine dosages; they had previously received immunosuppressive therapy. Antibody titres measured 1 year after seroconversion were found to be within the protective range (85-2500 mIU/ml). These results show that the impaired immune response to hepatitis B vaccination in young dialysis patients can be overcome by increasing the number of injections and the dose of the vaccine. Protective antibody titres are maintained for at least 1 year after vaccination. Immunosuppressive therapy may interfere with the vaccine response.     

血液透析与腹膜透析患者微炎症反应比较及其与营养状况、心血管疾病关系的研究

目的 研究血液透析、腹膜透析两种透析方式对慢性肾衰尿毒症患者微炎症状态的影响,探讨微炎症状态与营养状况、心血管疾病的关系.方法 选择2011年1月至2012年6月沈阳市红十字会医院肾内科住院的尿毒症患者64例(血液透析30例、腹膜透析34例)及健康对照者30例,检测C反应蛋白、白介素6、尿素氮、肌酐、白蛋白、前白蛋白、血红蛋白,计算体重指数.根据主观综合性营养评价将患者分为营养良好组、营养不良组.记录透析处方和心血管并发症.结果 本组尿毒症患者C反应蛋白、白介素6较对照组显著升高(P＜0.01),血液透析组C反应蛋白、白介素6显著高于腹膜透析组(P＜0.05).尿毒症各组内营养良好组C反应蛋白、白介素6较营养不良组显著升高(P＜0.05),合并慢性心衰组C反应蛋白、白介素6较无心衰并发症组显著升高(P＜0.05).C反应蛋白与白蛋白、前白蛋白呈显著负相关,与尿素氮、肌酐、血红蛋白无显著相关性.结论 血液透析患者微炎症状态比腹膜透析患者严重,尿毒症患者微炎症状态与营养不良及心血管疾病密切相关.     

Cardiovascular complications caused by advanced secondary hyperparathyroidism in chronic dialysis patients; special focus on dilated cardiomyopathy

Background The frequency and prognosis of dilated cardiomyopathy (DCM) caused by secondary hyperparathyroidism (2°HPT) is not known. The purpose of this study was to determine the morbidity of DCM caused by 2°HPT and the efficacy of parathyroidectomy (PTx) in chronic dialysis patients with advanced 2°HPT was analyzed prospectively.Methods Between November 2000 and January 2003, 237 dialysis patients who underwent total PTx with forearm autograft at our department were enrolled in this study. Cardiac complications that existed before PTx were examined. Ten patients (4%) had DCM without valvular disease (VD) or ischemic heart disease (IHD). In these 10 patients with DCM before operation, we estimated left ventricular (LV) function at 6 months after PTx, according to echocardiography findings and clinical symptoms.Results Six months after PTx, left ventricular ejection fraction (LVEF) in these 10 patients was significantly improved, from 31.0 ± 9.8% before PTx, to 56.8 ± 13.5% (P = 0.0003), and left ventricular end-diastolic dimension (LVDd) was reduced, from 59.8 ± 9.7 mm to 46.3 ± 7.0 mm (P = 0.0014). The symptoms due to DCM and the fall of blood pressure that had occurred during dialysis were clearly improved after PTx.Conclusions Advanced 2°HPT can influence LV function, and in patients who suffered from DCM, LV function was dramatically improved by PTx. PTx should be performed immediately in patients with DCM caused by 2°HPT.This study was presented at the American Society of Nephrology Annual Meeting, held at San Diego, CA, USA, on November 12–17, 2003.     

影响腹膜透析患者心脏瓣膜钙化与左房增大相关因素分析

目的 探讨腹膜透析患者心脏瓣膜钙化及左房增大的患病率与相关危险因素分析,为有效预防瓣膜钙化及左房增大的发生提供依据.方法 入选深圳市第二人民医院腹透中心稳定的接受规律持续性非卧床腹膜透析(CAPD)的患者,采集患者的人口统计学资料,测定血压,检测生化指标,评估患者的残肾功能和透析充分性,记录用药情况,使用心脏多普勒超声仪检测患者的心脏瓣膜钙化及左房内径情况.采用Logistic回归分析心脏瓣膜钙化和左房增大的危险因素.结果 71例患者入选本研究,男性38例(53.5％),女性33例(46.48％).所入选患者平均年龄(51.7±15.7)岁,平均透析龄(30.04±18.69)个月.其中28例(39.4％)患者存在心脏瓣膜钙化,31例(43.7％)患者存在左房增大.与无心脏瓣膜钙化患者相比,心脏瓣膜钙化患者的年龄(P=0.000)、左房内径(P=0.017)较大;尿素氮(P =0.028)、CTNI(P=0.005)、BNP(P=0.026)较高;总KT/V水平(P =0.007)较低.与左房内径正常的患者相比,左房增大患者的CTNI(P=0.009)、BNP(P =0.005)较高;铁蛋白(P =0.002)、总Ccr (P =0.041)较低.相关性分析表明,左房内径与年龄、CTNI、BNP、心脏瓣膜钙化呈正相关关系(P＜0.05);而血清总钙、铁蛋白、总Ccr呈负相关关系(P＜0.05).多因素Logistic回归分析结果显示年龄(OR=1.151,95％ CI:1.072～1.237,P=0.000),肌酐(OR=1.003,95％ CI:1.000 ～ 1.006,P=0.026)与这些患者发生瓣膜钙化独立正相关.尿素氮(OR=1.401,95％ CI:1.119～1.752,P=0.003),心脏瓣膜钙化(OR=21.149,95％ CI:1.737～ 257.459,P=0.017)与这些患者发生左房增大独立正相关;而尿酸(OR=0.982,95％ CI:0.967 ～ 0.997,P=0.017),视黄醇结合蛋白(OR =0.944,95％ CI:0.899 ～ 0.992,P=0.023),铁蛋白(OR=0.986,95％ CI:0.977 ～0.996,P=0.004)与左房增大独立负相关.结论 腹膜透析患者心脏瓣膜钙化和左房增大患病率较高.年龄、血清肌酐水平是心脏瓣膜钙化的独立危险因素,血清尿氮与心脏瓣膜钙化是左房增大的独立危险因素,血清视黄醇结合蛋白、血清尿酸、铁蛋白水平是左房增大的保护因素.左房增大与心脏瓣膜钙化互为因果,密切相关.     

维持性腹膜透析患者血清25羟维生素D浓度及影响因素分析

目的 观察维持性腹膜透析患者体内25羟维生素D[25(OH)D]的浓度及其影响因素分析.方法 选取2015年7月至2015年10月在无锡市人民医院腹膜透析中心行持续不卧床腹膜透析(CAPD)或白天不卧床腹膜透析(DAPD)治疗>6个月的终末期肾衰患者为对象进行横断面调查及回顾性分析.选择同期于本院体检中心行体检健康者100例为健康对照组.采用酶联免疫吸附试验(ELISA)方法检测上述研究对象的25(OH)D的水平,根据K/DOQI指南标准分为维生素D正常组、不足组、缺乏组.分析各组患者及健康对照组之间人口学、临床及实验室资料之间的差异.并分析影响25(OH)D浓度的因素.结果 110例腹膜透析患者的25(OH)D水平(23.27±10.22)ng/mL低于健康对照组25(OH)D水平(34.82±9.58)ng/mL,差异具有统计学意义(P<0.0001).腹膜透析患者中25(OH)D水平正常组22例(20%),不足组67例(60.9%),缺乏组21例(19.1%),提示大部分腹膜透析患者存在25(OH)D水平不足、缺乏.入选腹膜透析患者,女性25(OH)D 水平缺乏比例(31.91%)明显高于男性(9.52%).腹膜透析患者中25(OH)D缺乏组的血红蛋白、白蛋白显著低于正常组,而总胆固醇、低密度脂蛋白胆固醇显著高于正常组(P<0.05).缺乏组的血红蛋白、低密度脂蛋白胆固醇低于不足组,差异具有统计学意义(P<0.05).25(OH)D水平与白蛋白呈正相关(r=0.2883,P<0.0001),与血磷(r=-0.5156,P<0.0001)、甘油三酯(r=-0.2254,P=0.0179)、低密度脂蛋白胆固醇(r=-0.3004,P=0.0014)成负相关.结论 腹膜透析患者普遍存在维生素D缺乏或不足.25(OH)D水平与白蛋白呈正相关,与血磷、甘油三酯、低密度脂蛋白胆固醇成负相关.建议对于严重缺乏维生素D的腹膜透析患者予合理补充维生素D.     

The impact of foot ulceration and amputation on mortality in diabetic patients. I: From ulceration to death,a systematic review

A great deal of emphasis, clinical and financial, is placed on limb salvage efforts in diabetic patients suffering from lower extremity ulceration. This is because of the impression that amputation in such patients may be a proximal cause of death. While amputation is certainly a negative clinical outcome, it is not entirely clear that it causes death. In this systematic review, we examine the available literature to attempt to understand the role that the ulceration itself may play in mortality. In brief, we searched for human studies in OVID, CINAHL and the COCHRANE CENTRAL DATABASE from 1980 to 2013, looking for articles related to ulcer or wound of the foot, in patients with diabetes or peripheral vascular disease, and death. We looked for articles with 5 years of follow‐up, or Kaplan–Meier estimates of 5‐year mortality, and excluded reviews and letters. Articles were assessed for quality and potential bias using the Newcastle–Ottawa scale. We find that while the patient populations studied varied widely in terms of demographics and comorbidities, limiting generalisability, 5‐year mortality rates after ulceration were around 40%. Risk factors for death commonly identified were increased age, male gender, peripheral vascular disease and renal disease.     

Does increasing haemoglobin concentration and haematocrit have a pressor effect in dialysis patients?

The haemodynamic consequences of differing rates of rise of haemoglobin and haematocrit in haemodialysis and CAPD patients were examined. Pre-dialysis mean arterial pressure, weight and haematological indices were recorded in 100 established haemodialysis patients prior to a 2-unit blood transfusion and repeated, pre-dialysis, within 1 week. Haemoglobin rose from 6.7 +/- 0.2 to 9.3 +/- 0.1 g/dl, weight was unchanged, and there was a small fall in mean arterial pressure. Similar indices were recorded, including the mid-arm circumference (MAC) in 100 CAPD patients 1 month after starting CAPD and at the time of maximum haemoglobin within the first year. Haemoglobin rose from 8.5 +/- 0.1 to 10.7 +/- 0.1 g/dl, weight increased slightly, but there was no change in MAC: weight ratio and there was a small fall in mean arterial pressure. In neither group was there a change in antihypertensive medication. In conclusion, increasing the haemoglobin concentration and haematocrit of dialysis patients within the range described in this study did not promote elevated blood pressure.     

不同透析方式对终末期肾脏疾病患者钙磷代谢及炎症因子水平的影响

目的观察腹膜透析(PD)与血液透析(HD)对终末期肾脏疾病(ESRD)患者钙磷代谢及炎症因子水平的影响。方法筛选2016年1月至2019年2月在本院肾内科接受血液净化治疗的126例ESRD患者作为实验对象,应用分层随机分组法将所有患者分为两组,PD组(63例)给予非卧床持续性腹膜透析治疗,HD组(63例)给予血液透析治疗,观察两组患者治疗前、治疗后6个月后的钙磷代谢水平(血钙水平、血磷水平)、炎症因子水平[C反应蛋白(CRP)、肿瘤坏死因子-α(TNF-α)、白细胞介素6(IL-6)]以及肾功能[肾小球滤过率(GFR)、血尿素氮(BUN)、血肌酐(Scr)]的差异情况,对比两组患者治疗期间的并发症发生情况。结果PD组和HD组治疗后的血钙水平、血磷水平差异无统计学意义(P>0.05);HD组的CRP水平高于PD组(P<0.05),但两组的TNF-α、IL-6水平差异无统计学意义(P>0.05);两组患者的CFR、BUN、Scr水平差异无统计学意义(P>0.05);PD组的感染、低蛋白血症、充血性心力衰竭的发生率高于HD组(P<0.05),心率失常低于HD组(P<0.05),两组的高血压发生率差异无统计学意义(P>0.05)。结论PD和HD都可以有效改善ESRD患者的钙磷代谢情况和肾功能状态,但PD、HD治疗后都有轻微的炎症反应,且HD的炎症反应高于PD;建议根据临床实际情况选择最适宜患者的血液净化方式。     

A prospective,multicentre, open‐label,single‐arm clinical trial for treatment of chronic complex diabetic foot wounds with exposed tendon and/or bone: positive clinical outcomes of viable cryopreserved human placental membrane

Complex diabetic foot ulcers (DFUs) with exposed tendon or bone remain a challenge. They are more susceptible to complications such as infection and amputation and require treatments that promote rapid development of granulation tissue and, ultimately, reepithelialisation. The clinical effectiveness of viable cryopreserved human placental membrane (vCHPM) for DFUs has been established in a level 1 trial. However, complex wounds with exposed deeper structures are typically excluded from randomised controlled clinical trials despite being common in clinical practice. We report the results of a prospective, multicentre, open‐label, single‐arm clinical trial to establish clinical outcomes when vCHPM is applied weekly to complex DFUs with exposed deep structures. Patients with type 1 or type 2 diabetes and a complex DFU extending through the dermis with evidence of exposed muscle, tendon, fascia, bone and/or joint capsule were eligible for inclusion. Of the 31 patients enrolled, 27 completed the study. The mean wound area was 14·6 cm², and mean duration was 7·5 months. For patients completing the protocol, the primary endpoint, 100% wound granulation by week 16, was met by 96·3% of patients in a mean of 6·8 weeks. Complete wound closure occurred in 59·3% (mean 9·1 weeks). The 4‐week percent area reduction was 54·3%. There were no product‐related adverse events. Four patients (13%) withdrew, two (6·5%) for non‐compliance and two (6·5%) for surgical intervention.     

药用活性炭有效降低顽固性高磷血症透析患者血磷水平与钙磷乘积

目的 研究口服药用活性炭对未能控制的高磷血症透析患者血磷与钙磷乘积的作用.方法 采用单中心、前瞻性、自身前后对照研究.经含钙的磷结合剂治疗后仍存在高磷血症的血液透析或腹膜透析患者,餐中加服药用活性炭4.5～7.2 g/d治疗3个月.检测治疗前后血磷、钙、钙磷乘积、全段甲状旁腺激素( iPTH)、白蛋白、血红蛋白水平.用配对t检验进行统计学分析.结果 与治疗前比较,治疗3个月后患者血磷水平显著下降[(1.85±0.30)mmol/L比(2.16±0.34) mmol/L,P＜0.01];血钙磷乘积也相应显著下降[(54.12±8.37) mg2/dl2比(63.93±8.83) mg2/dl2,P＜0.01];有更多并发继发性甲状旁腺功能亢进症的患者可以接受维生素D治疗(83.3％比50％);血钙与iPTH水平无显著性变化(P=0.734,0.665).活性碳治疗期间血白蛋白水平较前下降[(40.1±2.2)g/L比(41.7±2.9) g/L,P=0.001].结论 顽固性高磷血症透析患者在继续原有磷结合剂治疗基础上,口服药用活性炭可以有效地降低血磷水平与钙磷乘积,对血钙及iPTH水平没有显著性影响.活性炭治疗可使患者血白蛋白水平轻度下降.