Effects of vacuum-compression therapy on healing of diabetic foot ulcers: randomized controlled trial

A single-blind, randomized controlled trial was conducted to evaluate vacuum-compression therapy (VCT) for the healing of diabetic foot ulcers. Eighteen diabetic patients with foot ulcers were recruited through simple nonprobability sampling. Subjects were randomly assigned to either an experimental or a control group. Before and after intervention, the foot ulcer surface area was estimated stereologically, based on Cavalieri's principle. The experimental group was treated with VCT in addition to conventional therapy for 10 sessions. The control group received only conventional therapy, including debridement, blood glucose control agents, systemic antibiotics, wound cleaning with normal saline, offloading (pressure relief), and daily wound dressings. The mean foot ulcer surface area decreased from 46.88 +/- 9.28 mm(2) to 35.09 +/- 4.09 mm(2) in the experimental group (p = 0.006) and from 46.62 +/- 10.03 mm(2) to 42.89 +/- 8.1 mm(2) in the control group (p = 0.01). After treatment, the experimental group significantly improved in measures of foot ulcer surface area compared with the control group (p = 0.024). VCT enhances diabetic foot ulcer healing when combined with appropriate wound care.     

含银敷料辅助治疗糖尿病足溃疡感染的效果观察

目的观察评价含银敷料辅助治疗糖尿病足溃疡感染的有效性。方法2012年5月一2014年4月对人选的105例糖尿病足溃疡患者随机分为A、B两组：患者在整体干预的基础上,A组使用进口的银离子藻酸盐敷料,B组使用国产纳米银敷料,在设定治疗时间内,通过观察创面细菌转阴率和伤口愈合计分评价含银敷料处理糖尿病足溃疡的效果。结果两组创面细菌转阴率基本一致（P〉0．05）,伤口愈合计分随着治疗时间的延长均呈下降趋势,但A组伤口愈合计分下降较B组明显（P〈0．01）。结论两种含银敷料辅助治疗糖尿病足溃疡创面感染均有效,但银离子藻酸盐抗菌敷料的促愈效果更佳;细菌转阴率和伤口愈合计分评价含银敷料的治疗效果是客观可行的观察指标。     

负压创伤治疗技术及生物半透膜覆盖治疗糖尿病皮肤慢性溃疡

背景：糖尿病患者全身营养状况不良和免疫功能低下导致其皮肤慢性溃疡愈合困难,常规创面治疗方法效果不佳。目的：探讨负压创伤治疗技术在糖尿病皮肤慢性溃疡治疗中的安全性和有效性。方法：纳入2007年7月至2010年12月在广西壮族自治区人民医院内分泌科治疗的糖尿病皮肤慢性溃疡患者144例,其中糖尿病足溃疡132例,压疮12例。分别采用负压创伤治疗技术或传统清创、换药方法治疗;同时均辅以控制血糖及血压、抗凝、抗感染及对症1支持治疗。结果与结论：采刚负压创伤治疗技术治疗的109例患者溃疡愈合60例,显效30例,有效14例,无效5例,总何效率95．4％。采用传统清创、换药方法治疗的35例患者溃疡愈合17例,显效10例,有效3例,无效5例,总有效率85.7％。两组总有效率比较差异有显著性意义（P〈0．05）。且负压创伤治疗可明显提高糖尿病足溃疡患者溃疡州边组纵氧分压,负压泵连续运行最长120d,无并发症出现。说明负压创伤治疗技术在糖尿病皮肤慢性溃疡治疗中具有良好的安全性和有效性。     

自体富血小板血浆在糖尿病足溃疡的临床应用

目的 探究自体富血小板血浆在糖尿病足溃疡治疗中的应用效果.方法 选择2020年8月至2021年8月我院收治的Wagner 2～4级糖尿病足溃疡患者40例进行研究,根据其治疗方案不同分为对照组和观察组,两组均予以常规基础治疗,在此基础上,对照组(n=18)予以创面清创和负压封闭引流,观察组(n=22)于创面上覆盖自体富血...     

HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers: a prospective, multicenter, controlled, randomized clinical trial

OBJECTIVE: To evaluate the clinical efficacy and safety of HYAFF 11-based autologous dermal and epidermal grafts in the management of diabetic foot ulcers. RESEARCH DESIGN AND METHODS: A total of 79 patients with diabetic dorsal (n = 37) or plantar (n = 42) ulcers were randomized to either the control group with nonadherent paraffin gauze (n = 36) or the treatment group with autologous tissue-engineered grafts (n = 43). Weekly assessment, aggressive debridement, wound infection control, and adequate pressure relief (fiberglass off-loading cast for plantar ulcers) were provided in both groups. Complete wound healing was assessed within 11 weeks. Safety was monitored by adverse events. RESULTS: Complete ulcer healing was achieved in 65.3% of the treatment group and 49.6% of the control group (P = 0.191). The Kaplan-Meier mean time to closure was 57 and 77 days, respectively, for the treatment versus control groups. Plantar foot ulcer healing was 55% and 50% in the treatment and control groups, respectively. Dorsal foot ulcer healing was significantly different, with 67% in the treatment group and 31% in the control group (P = 0.049). The mean healing time in the dorsal treatment group was 63 days, and the odds ratio for dorsal ulcer healing compared with the control group was 4.44 (P = 0.037). Adverse events were equally distributed between the two groups, and none were related to the treatments. CONCLUSIONS: The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing. For plantar ulcers, the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment. This treatment, however, may be useful in patients for whom the total off-loading cast is not recommended and only a less effective off-loading device can be applied.     

氦氖激光照射联合硼酸湿敷治疗老年患者压疮的效果

目的探讨氦氖激光照射联合硼酸湿敷治疗老年患者压疮的效果。方法将52例住院带有压疮的老年患者随机分成对照组和治疗组,对照组常规清洁疮面后用硼酸纱布湿敷;治疗组同样清创后给予氦氖激光照射压疮表面20min,再用硼酸纱布湿敷,每天1次。两组患者治疗期间均采用压疮综合治疗护理措施。观察30d压疮愈合情况。结果治疗组有效率为96．2％,对照组有效率为69．2％。两组比较差异有统计学意义（X2=4．837,P〈0.05）;治疗组显效时间也明显较对照组缩短[（12．19±6．40）d比（19．36±9．30）d],差异有统计学意义（t=-2.425,P〈0．05）。结论氦氖激光照射联合硼酸湿敷治疗老年患者压疮,能够促进伤口愈合,缩短病程。     

Strategies and challenges in the treatment of chronic venous leg ulcers

Evaluating patients with chronic venous leg ulcers (CVLUs) is essential to find the underlying etiology. The basic tenets in managing CVLUs are to remove the etiological causes, to address systemic and metabolic conditions, to examine the ulcers and artery pulses, and to control wound infection with debridement and eliminating excessive pressure on the wound. The first-line treatments of CVLUs remain wound care, debridement, bed rest with leg elevation, and compression. Evidence to support the efficacy of silver-based dressings in healing CVLUs is unavailable. Hydrogen peroxide is harmful to the growth of granulation tissue in the wound. Surgery options include a high ligation with or without stripping or ablation of the GSVs depending on venous reflux or insufficiency. Yet, not all CVLUs are candidates for surgical treatment because of comorbidities. When standard care of wound for 4 wk failed to heal CVLUs effectively, use of advanced wound care should be considered based on the available evidence. Negative pressure wound therapy facilitates granulation tissue development, thereby helping closure of CVLUs. Autologous split-thickness skin grafting is still the gold standard approach to close huge CVLUs. Hair punch graft appears to have a better result than traditional hairless punch graft for CVLUs. Application of adipose tissue or placenta-derived mesenchymal stem cells is a promising therapy for wound healing. Autologous platelet-rich plasma provides an alternative strategy for surgery for safe and natural healing of the ulcer. The confirmative efficacy of current advanced ulcer therapies needs more robust evidence.     

时间管理对糖尿病足患者血糖和创面的影响

目的探讨采用生物节律模式进行时间管理对糖尿病足患者血糖的影响。方法选择2011—2013年收治于上海市中西医结合医院的糖尿病足患者100例,随机分为观察组和对照组各50例。对照组采用常规护理;观察组在常规护理的基础上,按生物节律中的昼夜节律模式对糖尿病足患者实行时间管理。结果两组患者前后空腹血糖值、餐后2 h血糖值和糖化血红蛋白值比较,差异均有统计学意义(尸0.05);两组患者足部创面情况前后比较差异有统计学意义(P0.05)。结论运用时间管理能够有效改善糖尿病足患者的血糖指标,促进其足部创面的愈合,有利于患者的康复。     

Pressure ulcer, fibronectin, and related proteins in spinal cord injured patients.

Pressure ulcer is a common occurrence in spinal cord injured (SCI) patients and can lead to serious complications. With proper management, some patients exhibit satisfactory healing whereas others show slow or nonhealing ulcers. Fibronectin has been shown to accumulate in wound, opsonize macroaggregate debris for phagocytosis, promote revascularization, and facilitate fibroblast migration and proliferation. We explored the relationship of plasma fibronectin with healing potential in 21 SCI men with pressure ulcer. They received standard wound care and were observed for eight weeks. Ten otherwise healthy SCI men without pressure ulcer (SCI-controls) and 32 able-bodied normal individuals (normal controls) were also studied. Plasma fibronectin and related proteins, ie, fibrinogen, plasminogen, alpha 2-antiplasmin and Factor XIII, were measured. Ten of 21 SCI patients with pressure ulcer showed rapid healing within four weeks and had significantly higher fibronectin levels as compared with the 11 patients with poor healing ulcers, SCI controls, and normal controls. Factor XIII and alpha 2-antiplasmin were mildly reduced and fibrinogen values were significantly increased in all SCI groups. Plasminogen concentrations were comparable in all groups studied. It thus appears that plasma fibronectin rises in patients with fast healing ulcers but fails to do so in those with poor healing ulcers and as such may be predictive of the course of pressure ulcers.     

Inhibition by L-arginine and spermidine of hemoglobin glycation and lipid peroxidation in rats with induced diabetes.

The effect of L-arginine and spermidine on hemoglobin glycation and lipid peroxidation in serum of normal and diabetic rats was studied. Five groups of 40 rats were studied during 20 days and compared with a control group (Group I) that consisted of normal rats (N = 6) not treated with L-arginine or spermidine. Group II, diabetic rats (alloxan 120 mg/kg, i.p. at the day 0 and alloxan 60 mg/kg, i.p. at the day 10) were considered as diabetic control. Group III, diabetic rats treated with 10 mM L-arginine (i.p.). Group IV, diabetic rats treated with 10 microM spermidine (i.p.). Group V, normal rats treated with 10 mM L-arginine (i.p.). Group VI, normal rats treated with 10 microM spermidine (i.p.). The rats of each group were divided in subgroups of four each. Rats were anesthetized and blood was taken from aorta to determine glucose, triglycerides (TGs), total cholesterol (TC), low- and high-density lipoproteins (LDL and HDL), glycated hemoglobin (HbA(1C)), and thiobarbituric acid-reactive substances (TBARS). We observed that the alloxan concentrations used in this study reproduced the clinical manifestations of disease including hyperglycemia (from 116 +/- 7 mg/dl to 435 +/- 80 mg/dl) in 96 hours. As a consequence the levels of TGs, TC, LDL, TBARS, and HbA(1C) were increased, whereas HDL diminished. HbA(1C) concentration was significantly correlated with the concentration of TBARS. The L-arginine and spermidine injection tended to normalize the glycemia from 24 hours, similarly, hyperlipidemia, TBARS, and HbA(1C). From these results, we conclude that l-arginine and spermidine exerted an inhibitory effect of hemoglobin glycation and lipid peroxidation in vivo, which may be relevant in preventing diabetic complications.     

实时荧光PCR法定量小腿慢性静脉性溃疡表面的细菌分布

背景：小腿慢性静脉性溃疡表面的细菌在溃疡的愈合过程中起重要作用,但细菌的种类、密度与溃疡愈合的关系仍然存在争议。目的：探讨小腿慢性静脉性溃疡中的常见菌群种属和细菌量与溃疡愈合的关系。方法：纳入2009-05/2010-09重庆医科大学第一附属医院血管外科诊断为小腿慢性静脉性溃疡患者39例,共42条患肢。所有患者均进行标准的加压疗法治疗,经过6个月的随访以确定溃疡的愈合率,42条患肢中,28条患肢在6个月内完全愈合,为愈合组,14条患肢未完全愈合,为未愈合组。获取治疗前所有溃疡的组织样本,提取样本中的细菌基因组DNA,合成细菌的通用引物及下肢慢性静脉性溃疡中常见细菌种属的特异性引物,运用常规PCR及荧光定量PCR方法比较愈合组与未愈合组溃疡表面的细菌差异。结果与结论：愈合组和未愈合组标本中都可检测到细菌,最常见的细菌为金黄色葡萄球菌和铜绿假单胞杆菌。荧光定量PCR结果显示未愈合组标本中的细菌总量较愈合组明显增多（P〈0.05）,两组中金黄色葡萄球菌、铜绿假单胞杆菌的含量无明显差异（P〉0.05）。实验结果中未见任何一种溃疡的常见细菌种属与溃疡的愈合具有直接关系,而溃疡中的细菌总量与溃疡的愈合有较大的关联。结果表明溃疡表面细菌总量的增加引起的皮肤慢性感染可能是导致小腿慢性静脉性溃疡长期不愈合的重要原因。     

Multidisciplinary management of the diabetic foot ulcer

Diabetic foot ulcers are likely to occur in up to 25% of people with diabetes mellitus at some time in their life (Boulton et al, 2005). Without adequate management, there is a high risk of infection, gangrene, amputation and death. Over 50% of major amputations in the UK happen to people with diabetes, and within three years of amputation, 50% of patients will die. Diabetic foot ulcers need specific management, and some of the principles of moist wound healing do not apply. Diabetic patients with foot ulcers benefit from accurate and prompt assessment, diagnosis, treatment, and long-term follow-up in order to conserve the foot (Jeffcoate et al, 2006). Their management cannot be undertaken by one health care professional working in isolation, but should involve a multidisciplinary team to ensure that these complex wounds are treated appropriately. In this first of two articles, wound healing in the diabetic foot and the principles of assessment of the diabetic foot ulcer are discussed.     

The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial

OBJECTIVE: To determine if a human fibroblast-derived dermal substitute could promote the healing of diabetic foot ulcers. RESEARCH DESIGN AND METHODS: A randomized, controlled, multicenter study was undertaken at 35 centers throughout the U.S. and enrolled 314 patients to evaluate complete wound closure by 12 weeks. Patients were randomized to either the Dermagraft treatment group or control (conventional therapy). Except for the application of Dermagraft, treatment of study ulcers was identical for patients in both groups. All patients received pressure-reducing footwear and were allowed to be ambulatory during the study. RESULTS: The results demonstrated that patients with chronic diabetic foot ulcers of >6 weeks duration experienced a significant clinical benefit when treated with Dermagraft versus patients treated with conventional therapy alone. With regard to complete wound closure by week 12, 30.0% (39 of 130) of Dermagraft patients healed compared with 18.3% (21 of 115) of control patients (P = 0.023). The overall incidence of adverse events was similar for both the Dermagraft and control groups, but the Dermagraft group experienced significantly fewer ulcer-related adverse events. CONCLUSIONS: The data from this study show that Dermagraft is a safe and effective treatment for chronic diabetic foot ulcers.     

Effects of Non-thermal,Non-cavitational Ultrasound Exposure on Human Diabetic Ulcer Healing and Inflammatory Gene Expression in a Pilot Study

The purpose of this clinical study was to assess, in a limited patient population, the potential for a novel advanced wound care treatment based on low-frequency (20 kHz) low-intensity (spatial peak temporal peak intensity <100 mW/cm²; i.e., pressure amplitude of 55 kPa) ultrasound (LFLI-US), to affect wound closure rate in human diabetic foot ulcers (DFUs) and to effect changes in the relative expression of pro-inflammatory and anti-inflammatory genes. The ratio of expression of these genes, termed the M1/M2 score because it was inspired by the transition of macrophages from pro-inflammatory (M1) to anti-inflammatory (M2) phenotypes as wound healing progresses, was previously presented as a potential healing indicator for DFUs treated with the standard of care. We previously found that non-cavitational, non-thermal LFLI-US delivered with a pulse repetition frequency of 25 Hz was effective at improving wound healing in a pilot study of 20 patients with chronic venous ulcers. In this study, we assessed the potential for weekly LFLI-US exposures to affect wound healing in patients with diabetic ulcers, and we analyzed temporal changes in the M1/M2 score in debrided diabetic wound tissue. Although this was a limited patient population of only 8 patients, wounds treated with LFLI-US exhibited a significantly faster reduction in wound size compared with sham-treated patients (p < 0.001). In addition, the value of the M1/M2 score decreased for all healing diabetic ulcers and increased for all non-healing diabetic ulcers, suggesting that the M1/M2 score could be useful as an indicator of treatment efficacy for advanced DFU treatments. Such an indicator would facilitate clinical decision making, ensuring optimal wound management and thus contributing to reduction of health care expenses. Moreover, the results presented may contribute to an understanding of the mechanisms underlying ultrasonically assisted chronic wound healing. Knowledge of these mechanisms could lead to personalized or patient-tailored treatment.     

负压伤口治疗技术用于53例慢性伤口的效果评价

目的 评价负压伤口治疗技术用于各类慢性伤口的效果.方法 入选Ⅳ度压疮、外伤伤口、术后切口和糖尿病足溃疡共计53例69处,清创后采用一致性操作流程和- 125mmHg(1 mmHg=0.133kPa)负压及间歇吸引模式治疗21d,有手术指征者转外科治疗,无手术指征者按标准湿性疗法治疗至愈合.观察治疗7d、14d、21d后伤口面积、深度、温度、pH值变化及100％肉芽覆盖时间和治愈率.结果 负压封闭辅助闭合(VAC)治疗后伤口治愈率78.26％(54/69),平均愈合时间(94.00±63.26)d,其中30例43处伤口负压治疗结束后继续接受湿性疗法治愈,10例11处伤口负压治疗结束后转外科手术治愈.12例负压治疗好转后回家继续治疗,随访5个月,愈合5例5处.总治愈率85.51％(59/69).负压治疗4类慢性伤口21d时的伤口温度较治疗前明显升高,pH值明显降低,差异均有统计学意义(P＜0.01);100％肉芽覆盖时间平均为(22.96±12.20)d.结论 VAC治疗对不同类型慢性伤口均有效,能够营造有利于伤口愈合的温度和酸碱度,促进肉芽组织生长和伤口收缩及愈合.     

Human epidermal growth factor enhances healing of diabetic foot ulcers

OBJECTIVE: To study the healing effect of recombinant human epidermal growth factor (hEGF) on diabetic foot ulcers. RESEARCH DESIGN AND METHODS: A total of 127 consecutive patients were screened and 61 diabetic subjects were recruited into this double-blind randomized controlled study. Predetermined criteria were used for diagnosis and classification of the diabetic wound. The patients were randomized into three groups. All patients attended our Diabetes Ambulatory Care Center every other week for joint consultation with the diabetologist and the podiatrist. Group 1 (control) was treated with Actovegin 5% cream (Actovegin), group 2 with Actovegin plus 0.02% (wt/wt) hEGF, and group 3 with Actovegin plus 0.04% (wt/wt) hEGF. The study end point was the complete closure of the wound. Failure to heal was arbitrarily defined as incomplete healing after 12 weeks. RESULTS: Final data were obtained from 61 patients randomly assigned into three groups. The mean ages of the patients, wound sizes, wound duration, metabolic measurements, and comorbidities were comparable within groups, except that group 3 had more female patients. Mean follow-up for the patients was 24 weeks. Data were cutoff at 12 weeks, and results were analyzed by intention to treat. After 12 weeks, in group 1 (control) eight patients had complete healing, two patients underwent toe amputation, and nine had nonhealing ulcers. In group 2 (0.02% [wt/wt] hEGF) 12 patients experienced wound healing, 2 had toe amputations, and 7 had nonhealing ulcers. Some 20 of 21 patients in group 3 (0.04% [wt/wt] hEGF) showed complete wound healing. Healing rates were 42.10, 57.14, and 95% for the control, 0.02% (wt/wt) hEGF, and 0.04% (wt/wt) hEGF groups, respectively. Kaplan-Meier survival analysis suggested that application of cream with 0.04% (wt/wt) hEGF caused more ulcers to heal by 12 weeks and increased the rate of healing compared with the other treatments (log-rank test, P = 0.0003). CONCLUSIONS: Our data support the contention that application of hEGF-containing cream, in addition to good foot care from a multidisciplinary team, significantly enhances diabetic foot ulcer wound healing and reduces the healing time.     

康复新液湿润疗法在溃疡期压疮中的应用效果观察

目的:探讨康复新液湿润疗法在溃疡期压疮中的应用效果。方法:将我院2007年1月～2009年4月内科系统收治的32例溃疡期压疮病人作为对照组,将2009年8月～2011年12月内科系统收治的32例溃疡期压疮病人作为观察组。观察组用生理盐水清洗创面及周围皮肤后再用康复新液湿性换药,对照组用碘伏消毒创面及周围皮肤,再用TDP灯照射20～30 min,然后用康复新液换药。结果:两组总有效率及压疮治愈时间比较差异有统计学意义(P=0.003)。结论:用康复新液湿润疗法效果显著,可提高压疮治愈好转率及缩短压疮愈合时间,节省护理人力资源,因此,在溃疡期压疮病人中可优先选用。     

湿性愈合疗法联合高压氧治疗糖尿病足溃疡的效果

目的 探讨湿性愈合疗法联合高压氧治疗糖尿病足溃疡的应用.方法 通过在临床实践中以传统换药为基础,再使用湿性愈合疗法联合高压氧治疗糖尿病足溃疡,评价患者对该疗法的满意度、切口愈合率、愈合时间、换药次数,并与单独使用传统换药相比较,进行两者之间的差异分析.结果 实验组显效18例（85.7％）,有效3例（14.3％）,对照组显效10例（47.6％）,有效6例（28.6％）,无效5例（23.8％）,两组比较差异有统计学意义（x2=5.68,P＜0.05）;愈合时间实验组需要（27.8±3.75）d,对照组需要（38.6±3.81）d,两组比较差异有统计学意义（t=9.2,P＜0.05）;换药次数实验组需要（15.6±3.45）次,对照组需要（24.8±3.62）次,两组比较差异有统计学意义（t=8.4,P＜0.05）;患者满意度实验组为95.4％优于对照组的68.9％,两组比较差异有统计学意义（t=5.15,P＜0.05）.结论 采用以传统换药为基础,再使用湿性愈合疗法联合高压氧治疗糖尿病足溃疡能明显提高创面愈合率,减少换药次数,减轻护士工作量,其结果可为合理应用该疗法促进糖尿病足溃疡愈合又可减少患者的痛苦提供临床依据.     

Randomized controlled trial of topical hyperbaric oxygen for treatment of diabetic foot ulcers

The effect of 2 wk of topical hyperbaric oxygen (THO) treatment on the healing of diabetic foot ulcers without associated gangrene was evaluated in a prospective, controlled, and randomized manner in 28 patients. There were 12 patients in the THO group (group 1) and 16 in the control group (group 2). Clinical management of the two patient groups was similar except for THO treatment in the group 1 patients. Clinical parameters, including age, sex, baseline fasting serum glucose levels, duration of diabetes mellitus, duration of foot ulcers, presence of peripheral neuropathy or arterial insufficiency, and evidence of osteomyelitis as determined by radiographs and/or radionuclide scans, were comparable in both groups of patients. No statistical differences (Student's t test) were seen in the number of microorganisms isolated from curettage cultures of the base of the ulcer at days 0, 7, and 14 of the study between groups 1 and 2. In contrast to previous studies, there was a paucity of anaerobic microorganisms isolated from these foot ulcers without associated gangrenous changes. Ulcer areas were estimated by multiplying the maximum width by the maximum length in millimeters at days 0, 7, and 14. Analysis of variance and Student's t test revealed progressive significant reductions in the ulcer areas in both groups when days 0, 7, and 14 were compared and in ulcer depths in both groups when days 0 and 14 were compared. However, such ulcer size changes did not differ statistically between the control and THO groups. A trend toward slower healing was observed in the THO group. Healing of diabetic foot ulcers was not accelerated by THO in this study.