Volume 10 · Issue 07 · 2018

In the past 20 years, under the leadership and support of the Diabetology Branch of Chinese Medical Association, and through the hard work of several generations of members of the Diabetic Foot and Peripheral Vascular Disease Group, great achievements have been made in the management of diabetic foot in China, and the amputation rate of diabetic foot, especially the large amputation rate, has been significantly reduced^[1]； However, as the incidence of diabetes in China increases year by year, the incidence of diabetic foot also increases, and the recurrence rate of diabetic foot ulcer after cure is as high as 31.6%, and the mortality rate is as high as 14.4%^[2]It imposes a great burden on patients, families and society. Therefore, how to further improve the cure rate of diabetic foot, reduce its incidence, amputation rate, mortality rate and recurrence rate after ulcer healing, as an important agenda in front of us, it is time to think about how to reform the management mode of diabetic foot in China.

diabetic foot (DF) is one of the serious complications of diabetic patients. About 25% of patients will develop foot lesions in their lifetime, which is the main reason for hospitalization of diabetic patients. In China, the annual incidence rate of diabetic foot ulcer is 8.1%, the annual amputation rate is 5.1%, and the annual mortality rate is 14.4%^[1]It is the main cause of chronic wounds. After statistical analysis of patients in tertiary A hospitals, it was found that 27.3% of amputations were caused by DF, accounting for 56.5% of non-traumatic amputations; Medical costs are about twice as high as those of non-podiatric patients^[2]。 Therefore, DF causes great psychological and economic burden to patients, families and society.

To evaluate the clinical application and efficacy of endovascular interventional therapy in diabetic foot.

Fifty diabetic patients admitted to our hospital from March 2016 to June 2017 were randomly divided into control group (26 cases) and interventional group (24 cases). The control group was administrated with comprehensive internal medicine treatment, and extra endovascular interventional therapy was added to the intervention group.

The total remission rate in the intervention group was significantly higher than that in the control group [91.6% (22/24) vs 53.8%(14/26), χ ²=8.854, P=0.002]. The healing time of ulcer in the intervention group was significantly lower than that in the control group [ (48±10) vs (91±9) d, t=3.285, P<0.05], and the length of hospital stay was lower than that in the control group [ (22±4) vs (38±4) d, t=3.521, P<0.05]. The clinical symptom scores of all patients were improved after treatment, and it was better in the intervention group than that in the control group [ (3.5±1.5) vs (11.8±2.3) point, P<0.05]. The patients in the intervention group were followed up for 1 month, 3 months and 6 months. The proportion of moderate and severe numbness, pain and low skin temperature were lower than those before operation, the ankle brachial index was higher than that before operation (all P<0.05).

The effect of interventional treatment of ischemic artery in patients with diabetic foot is definite. The clinical symptoms of the patient are improved obviously. The ulcer is relieved effectively, the complications of operation are few, and it is worthy of clinical application.

To evaluate the safety and effectiveness of application of human amniotic membrane on the treatment of diabetic foot ulcer.

Databases including Cochrane Central Register of Controlled Trails, PubMed, Embase, OVID, CBMDisc, CNKI, Chinese VIP Database and WANFANG Database were applied and proceedings of the American Diabetes Association were manually retrieved to select randomized controlled trials over application of human amniotic membrane on the treatment of diabetic foot ulcer published until February 2017. The bibliographies of retrieved articles were also retrieved. Two researchers selected studies according to inclusion and exclusion criteria, extracted related data, and conducted Meta-analysis by RevMan5.3 statistical software independently.

Totally 9 studies containing 595 patients with diabetic foot ulcer were included. Meta-analysis showed: (1) Diabetic foot ulcer healing rate: Human amniotic membrane was superior to conventional treatment [71.38% (212/297) vs 28.19% (84/298) , RR=2.54, 95%CI: 2.10-3.07, P<0.001]. (2) Diabetic foot ulcer healing time: Human amniotic membrane was superior to conventional treatment (SMD=-0.97, 95%CI: -1.38--0.56, P<0.001). (3) Area reduction rate of diabetic foot ulcer: Two studies showed that human amniotic membrane might had the effect of improving the area of ulcer reduction rate (P<0.001) . (4) Complications: No patient in these trials had complications or side effect associated with human amniotic membrane.

According to the Meta-analysis of the 9 studies, human amniotic membrane dressing is effective and safe in the treatment for diabetic foot ulcer, but further studies are needed.

To research the clinical efficacy of negative-pressure wound therapy with instillation of FufangHuangbaiye on diabetic foot infection wound and to observe its influence on related inflammatory factors.

120 patients with diabetic foot were enrolled in this study, who had ever hospitalized in the department of vascular diseases, Dongzhimen hospital, Beijing University of Chinese Medicine from December 2015 to January 2018. The patients were divided into experimental group (60 cases) and control group (60 cases) according to the random number table method. The patients in experimental group were treated with negative-pressure wound therapy with instillation of Fufang-Huangbaiye, meanwhile those in control group were treated with negative pressure wound therapy with instillation of normal saline. After 2 weeks and 4 weeks, the wound surface area, serum procalcitonin(PCT), interleukin-6 (IL-6), C-reactive protein (CRP) and local symptom score of two groups, as well as secretion culture of wounds were analyzed. Variance analysis was used to compare data difference in each group, t test or rank sum test were used to compare data difference between two groups.

(1) Basel diabetic course, glycated hemoglobin A_1c, wounds area, etc: There was no significance between two groups (all P>0.05). (2) Wound area and symptom score: After 2 weeks of treatment, the wound area and the symptom score in two groups were both reduced. After 4 weeks of treatment, the wound area reduction and symptom score in experimental group were better than those in control group [(2.3±2.0) vs (4.4±2.9) cm², (5±3) vs (7±3) score, t=4.544, 3.321 respectively, both P<0.001]. (3) Related inflammatory factors: after 2 weeks of treatment, the levels of serum PCT, CRP and IL-6 in the two groups both decreased (t=2.282-16.745, all P<0.001), but lower in experimental group than those in control group (t=2.867, 4.110, 3.241, respectively, all P<0.05). After 4 weeks, the level of PCT, CRP and IL-6 in two groups further decreased compared with those in the treatment for 2 weeks, however without significant difference between two groups (all P>0.05). (4) Bacteriological changes: after 2 weeks of treatment, the positive rate of bacterial culture in experimental group and control group decreased from 100% to 31.67%(19/60) and 66.67%(40/60), respectively (χ²=100.022, 37.162, both P<0.001), with statistically significance between two groups (χ²=23.122, P<0.001). After 4 weeks of treatment, the positive rate of bacterial culture in 2 groups were 21.67%(13/60) and 55.00% (33/60) respectively, without significant difference compared with that after 2 weeks treatment (P>0.05), but much lower in experimental group than that in control group (χ²=21.624, P<0.001).

Negative-pressure wound therapy with instillation of FufangHuangbaiye can control diabetic foot wound infection, promote wound healing, and improve clinical symptoms. Its effect is better than negative pressure wound therapy with instillation of normal saline.

We conducted a systematic review and meta-analysis to clarify risk factors for major amputation in patients with diabetic foot.

Observational studies of risk factors for major amputation in patients with diabetic foot published before September 2017 were searched on PubMed and EMBASE. Analysis was performed using Stata 12.0 statistical software and study quality was rated by Newcastle-Ottawa scale (NOS).

Ten observational studies was identified with 659 major amputation patients and 4 905 controls. Across studies, the overall odds ratios (OR) and 95% confidence intervals (95%CI) of significant risk factors were the depth of ulcer involved bone (OR=11.80, 95%CI 6.90-20.15), dialysis (OR=5.19, 95%CI 2.69-10.04), peripheral arterial disease (PAD) (OR=4.80, 95%CI 2.22-10.36), gangrene (OR=4.67, 95%CI 1.62-13.48), hind foot position (OR=3.64, 95%CI 1.19-11.13), decreased ankle brachial index (ABI) (OR=3.36, 95%CI 1.51-7.52), lower albumin levels (OR=3.13, 95%CI 1.82-5.37), anemia (OR=2.66, 95%CI 1.22-5.79), infection (OR=2.52, 95%CI 1.71-3.71), elevated serum creatinine (OR=1.19, 95%CI 1.08-1.31), ischemic heart disease (IHD) (OR=1.39, 95%CI 1.05-1.84). While there were no significant difference in white blood cell (WBC), C reactive protein (CRP), diabetic peripheral neuropathy (DPN), glycated hemoglobin A_1c (HbA_1c), hypertension and Charcot foot (all P>0.05).

Factors associated with major amputation in patients with diabetic foot are the depth of ulcer involved bone, dialysis, PAD, gangrene, hind foot position, decreased ABI, lower albumin levels, IHD, there is no relation with WBC, CRP, HbA_1c, DPN, hypertension and charcot foot.

To investigate the efficacy in a Shared Care mode for diabetes managed by a multi-disciplinary team consisting of physician, dietitian and nurse.

Data of regular clinic rate, laboratory tests during follow-ups, insulin injection points, foot examination results, scaling evaluation and daily expenditure were analyzed in diabetic patients of a shared care clinic from the First Hospital, Peking University between Oct. 2016 and Oct. 2017. Statistical analysis were proceeded by paired sample t-test and Wilcoxon Nonparametric Test.

Three hundred and eighty-two patients were followed up regularly, 382, 133, 101 and 110 patients attended the first visit, the first, second and third quarter follow-ups, respectively. The rate of regular follow-ups was 73%-100%. In the third quarter follow-up, the rate of glycemic control [hemoglobin A_1c, HbA_1c<7%] was 68.2%, the rate of cholesterol control [low density lipoprotein cholesterol, LDL-C<2.6 mmol/L] was 58.8%. In the second quarter follow-up, scaling evaluation improved significantly than those of the first follow-up including glucose self-tests, glucose monitoring under doctor's instructions, self-management of diabetic foot [ (2.2±2.4) vs (3.1±2.3) point,t=3.299, P<0.005; (2.1±2.7) vs (2.9±2.5) point,t=2.098, P<0.05; (2.4±3.0) vs (4.0±3.0) point,t=3.609, P<0.001, respectively]; Daily expenditure also reduced significantly [10.29 (3.45, 21.60) vs 9.57 (3.71, 20.76) yuan,P<0.0001].

Shared care clinic for diabetes may significantly increase the regular follow-up rate and self-management ability, and efficiently improve and maintain the control of metabolic indicators to target values.

To investigate the correlation between glycemic variability and sudomotor function in patients with type 2 diabetes mellitus (T2DM).

A total of 395 cases with T2DM in the Department of Endocrinology, Nanjing General Hospital of the PLA from March 2016 to May 2017 were enrolled. According to the electrical skin conductivities (ESC) of hands and feet measured with SUDOSCAN, a conductance analyzer, the patients were divided into two groups: 221 cases with normal sudomotor function (normal group, both ESC of hands and feet >60 μs, including 144 males, 77 females) and 174 cases with abnormal sudomotor function (abnormal group, ESC of hands or feet ≤60 μs, including 104 males and 70 females). All participants were monitored with the continuous glucose monitoring system for consecutive 72 hours. Clinical and biochemical indexes were recorded. Biochemical indexes and glycemic variability parameters were compared between the two groups. Spearman correlation analysis and the multiple linear regression analysis were adopted for statistical analysis.

(1) Compared with the normal sudomotor function group, the abnormal group were with older age [(59±12) vs (52±13) yrs, t=-5.252, P<0.001], longer diabetic duration [10(5, 16) vs 4(1, 10) yrs, Z=-6.152, P<0.001] and higher level of creatinine [60(47, 76) vs 52(42, 63) μmol/L, Z=-4.175, P<0.001]. (2) The parameters of glycemic variability, such as mean amplitude of glycemic excursions (MAGE) and mean of daily differences in abnormal group were higher than those in the normal group [(6.3±2.2) vs (5.7±1.7) mmol/L, (2.8±1.5) vs (2.4±1.4) mmol/L, t=-3.050, -2.381, both P<0.05]. (3) Spearman correlation analysis showed that the correlation coefficient between hands ESC, feet ESC, hand mean asymmetry, foot mean asymmetry and the parameters of glucose variability in glycated hemoglobin A_1c (HbA_1c) <8.0% subgroup were generally higher than those in 8.0%≤HbA _1c≤9.6% subgroup and HbA_1c>9.6% subgroup (r value: 0.058-0.368 vs 0.003-0.282, 0.007-0.237). The correlation coefficients between HESC, FESC, hand mean asymmetry, foot mean asymmetry and glycemic variability parameters were generally larger in male group than those in female group (r value: 0.023-0.215 vs 0.003-0.219). (4) Stepwise multiple linear regression analysis revealed that MAGE, duration of disease and creatinine were the independent risk factors affecting sudomotor function (B=-1.550, -0.758, -0.118, all P<0.05).

MAGE, duration of disease and creatinine are the independent risk factors affecting sudomotor function in patients with T2DM. Glycemic variability are more likely to affect the sudomotor function in male patients and patients with lower level of HbA_1c.

To investigate the clinical characteristics and metabolic risk factors of with type 2 diabetes mellitus (T2DM) complicated with non-alcoholic fatty liver disease (NAFLD) in children.

A total of 473 children with T2DM admitted to Beijing Children's Hospital from February 2008 to December 2015 consisting of 90 patients with NAFLD and 383 patients without NAFLD. Clinical data were collected and analyzed including gender, age, duration of diabetes, height, weight, waist and hip circumference, body mass index, blood pressure, hemoglobin, serum lipid and uric acid, glycated hemoglobin (HbA_1c), fasting plasma glucose, 2-hour postprandial glucose level, fasting insulin and C-peptide, insulin resistance index (HOMA-IR) in steady-state model. The t test and rank sum test were used in the comparison group, and Logistic regression was used for multivariate analysis.

(1) In the 473 children with T2DM, 90 cases (19.03%) were complicated with NAFLD. (2) In T2DM with NAFLD group, the levels of age, height, weight, body mass index, systolic and diastolic blood pressure, liver function, serum lipid and uric acid were significantly higher than those in non-NAFLD group (P<0.05). The levels of hemoglobin, HOMA-IR, fasting insulin and C-peptide in NAFLD group were significantly higher than those in non-NAFLD group [(142±11) vs (134±14) g/L, 2.7(1.7, 4.4) vs 1.4(0.5, 3.1), 10.2(6.0, 15.1) vs 4.8(1.7, 10.3) μU/ml, 2.5(2.3, 3.0) vs 0.7(0.3, 22.0) μg/L, t=-5.037, Z=7 900, 8 858, 4 062, all P<0.01]. The 2-hour postprandial glucose level was lower than that in non-NAFLD group [(12.2±4.0) vs (13.6±4.2) mmol/L, t=2.473, P<0.05]. (3)Unconditional multivariable logistic regression analysis showed that hemoglobin concentration and uric acid were independent risk factors for T2DM with NAFLD with odds ratio 3.981 and 3.645 respectively (both P<0.05).

T2DM with NAFLD usually occurs in the older and obese children with more severe blood pressure, serum lipids, uric acid, hemoglobin, liver function. Hemoglobin level and increased uric acid may help predict the development of NAFLD in children with T2DM.

To explore the clinical manifestations, pathogenesis and treatment of insulin-induced lipoatrophy.

Data of a case of exogenous insulin antibody syndrome (EIAS) and acquired lipoatrophy caused by insulin injection were collected and analyzed. From January 2010 to January 2018, clinical data of patients diagnosed with insulin-induced lipoatrophy in Peking Union Medical College Hospital were summarized.

A total of 11 cases were diagnosed as insulin-induced lipoatrophy with 11 cases of lipoatrophy at the injection site, while 2 cases with present of lipoatrophy at the non-injection site. Both recombinant human insulin preparations and the insulin analog preparations were involved in lipoatrophy. It mostly occurred in 2 weeks to 3 years after the initiation of insulin injection. High titers of insulin autoantibodies (IAA) were found in 8 patients, of which 6 patients manifested with blood glucose fluctuation, hypoglycemia at night and elevated serum insulin level, which could be diagnosed as EIAS.

Both localized lipoatrophy and distant site lipoatrophy could be induced by insulin injection. High titers of IAA could lead to both EIAS and lipoatrophy which may occur at the same time. The mechanism might be attributed to autoimmune reaction triggered by insulin injection. When encountered with unexplained blood glucose fluctuations with concomitant lipoatrophy, serum insulin levels and IAA tests are strongly recommended to confirm EIAS.

To evaluate the effects of individualized one-stop treatment on diabetic foot (DF) which cooperated by physicians and surgeons.

Of those DF patients, 98 patients (group N1, from January 2014 to December 2015), 70 patients (group N2, from Endocrine Center between January 2016 and March 2017) without individualized one-stop treatment and 109 patients (group Y, from Endocrine Center between January 2016 and March 2017) with individual one-stop treatment were recruited in this study. The data of gender, age, weight, glycated hemoglobin A_1c and Wagner grade etc. were collected and compared among three groups. Efficacy of follow-up at 3 months and 6 months in each group treatment, costs and patients' satisfaction rate were collected. Chi-square test andt test were used for statistical analysis.

The proportion of Wagner 4 in group Y were higher than those in group N1 and N2 [49 (45.0%) vs 17 (17.3%) vs 22 (31.4%) ] and ankle brachial index<0.6 [26(23.9%) vs 8(8.2%) vs 6(8.6%)] (χ²=6.780-18.109, all P<0.05) . The healing rate [3 month: 54 (49.5%) vs 26 (26.5%) vs 20 (34.6%) ; 6 month: 97 (89.0%) vs 41 (41.8%) vs 32 (45.7%) , χ ²=4.254-6.121, all P<0.05], total hospitalization expenses [ (21 307.7±6 204.6) vs (13 575.8±3 981.2) vs (19 323.0±4 356.1) yuan, t=2.852, 2.343, both P<0.05] of group Y in 3 months, 6 months were significantly higher than those of group N1 and group N2, respectively. The amputation rate above malleolus [8 (7.3%) vs 19 (19.4%) vs 13 (18.6%) , χ ²=5.802, 5.193, both P<0.05], the average hospital stays of cured patients [ (16.9±4.8) vs (21.7±11.3) vs (19.1±4.9) d, t=3.324, -2.911, both P<0.05] were lower than those of group N1 and group N2, respectively.

Individualized one-stop treatment mode in DF has higher healing rate and lower hospitalization days, and could be worthy of clinical promotion.

type A insulin resistance syndrome (TAIRS) is an autosomal recessive or dominant genetic disease. insulin receptor (INSR) gene mutation affects the binding of insulin to insulin receptor, thus causing insulin dysfunction. It is more common in adolescent women, mainly manifested as severe insulin resistance, hyperandrogenemia, acanthosis nigricans, and may be accompanied by polycystic ovary syndrome (PCOS) manifestations^[1,2]。 1976 Kahn et al.^[3]TAIRS was proposed for the first time. At present, TAIRS is rarely reported at home and abroad, and its onset is hidden. There is no clear standard for its diagnosis and treatment, and it is easy to miss and misdiagnose in clinical practice. This paper reports a typical case of TAIRS, and reviews its clinical characteristics, gene mutations, treatment and prognosis, as well as related literatures, in order to improve the understanding of this disease.

Diabetic foot (ulcer) refers to foot infections, ulcers, and/or deep tissue destruction that occur in diabetic patients and are associated with regional neurological abnormalities and distal peripheral vascular lesions of the lower extremities. People at high risk of diabetic foot: according to the International Diabetic Foot Working Group Diabetic Foot Prevention Guidelines^[1,2]Definition, that is, diabetic patients who have established diabetes mellitus and have one or more of the risk factors for diabetic foot, such as severe peripheral neuropathy, foot deformity, peripheral vascular disease, history of diabetic foot ulcers, history of partial foot amputation or leg amputation, etc., and currently do not have foot ulcers. There is no diagnosis of symptomatic diseases for people at high risk of diabetic foot in TCM literature, but diabetic foot belongs to the category of "gangrene removal" in TCM, so the high-risk group of diabetic foot is designated as "gangrene removal (diabetic foot disease-diabetic limb arterial occlusive disease) unulcerated stage". According to the definition of diabetic foot in the Guidelines for Diabetes Prevention and Treatment of Diabetic Foot of Chinese Society of Traditional Chinese Medicine, this disease belongs to the category of "tendon gangrene" and "gangrene removal", and Wagner grade 0 is called high-risk foot^[3]。