The aim of the study was the comparison of a simple standardized noninvasive examination of neuropathy and angiopathy with routine diagnostic practice in community diabetes clinics for the ...identification of patients at risk of foot ulceration. Consecutive patients (
n=322), aged 30 years and more, with a diabetes duration of more than 5 years, were examined by trained podiatric nurses in six diabetes clinics over a 1-year period; 44 of these patients had active or previous foot ulcerations. We evaluated the differences between the routine diagnostic practice (based on the patient's medical history and a physical examination) and noninvasive testing of peripheral neuropathy vibration perception threshold (VPT) and the Semmes-Weinstein 10-g monofilament wire system and angiopathy Doppler ankle/brachial index (ABI). Using receiver operating characteristic (ROC) analysis, we evaluated the sensitivity and specificity of noninvasive testing methods for identifying patients at risk and selecting the optimal diagnostic cutoff points. Patients with severe neuropathy, as determined by noninvasive testing (VPT ≥30 V and/or insensitivity to 10 g monofilament), had been diagnosed to have neuropathy in diabetes clinics in 54% of cases. Patients with angiopathy at risk of developing diabetic foot ulcers (ABI ≤0.8) had been diagnosed, in diabetes clinics, to have peripheral arterial disease in 50% (they reported claudications in 41%, had femoral artery bruits detected in 29% and nonpalpable peripheral pulsations in 12%). Our findings stress the importance of using standardized simple noninvasive testing methods to increase the accuracy of identifying patients at risk for the diabetic foot at the community level.
The release of proangiogenic cytokines into the circulation after stem cell (SC) therapy and compensatory increase of angiogenesis inhibitors may reflect local vasculogenesis but also can increase ...the risk of side effects. The aim of our study was to evaluate serum levels of angiogenic cytokines with regard to the assessment of local and systemic vasculogenesis in diabetic patients with no-option critical limb ischemia (NO-CLI). Twenty-five diabetic patients with NO-CLI treated with SCs isolated from bone marrow or stimulated peripheral blood were included in the study. Serum levels of proangiogenic cytokines (VEGF, bFGF, Ang-1, PDGF-AA, and PDGF-BB) and an antiangiogenic cytokine (endostatin) were assessed 6 months after cell treatment, compared to baseline values, and correlated with the number of injected CD34+ cells. The clinical effect of SC therapy (assessed by changes in TcPO2) and potential systemic vasculogenesis (assessed by eye fundus examination) were evaluated after 6 months. Serum levels of angiogenic inhibitor endostatin increased significantly after 1 and 3 months (p = 0.0003), but no significant increase in serum levels of proangiogenic cytokines was observed. A significant correlation between number of injected CD34+ cells and serum levels of endostatin was observed (r = 0.41, p < 0.05); however, proangiogenic cytokines did not correlate with CD34+ cells. No correlation between increase in TcPO2 after treatment and serum levels of any of the angiogenic cytokines were seen, and no signs of systemic vasculogenesis in the retina were observed after 6 months. Despite the significant increase in the levels of the angiogenic inhibitor endostatin following SC treatment, there was no risk of systemic vasculogenesis after SC therapy as documented by serum levels of proangiogenic cytokines or changes in the retina.
The standard method for assessment of effect of revascularization in patients with diabetic foot (DF) and critical limb ischemia (CLI) is transcutaneous oxygen pressure (TcPO2). Phosphorus magnetic ...resonance spectroscopy (31P MRS) enables to evaluate oxidative muscle metabolism that could be impaired in patients with diabetes and its complications. The aim of our study was to compare MRS of calf muscle between patients with DF and CLI and healthy controls and to evaluate the contribution of MRS in the assessment of the effect of revascularization.
Thirty-four diabetic patients with DF and CLI treated either by autologous cell therapy (ACT; 15 patients) or percutaneous transluminal angioplasty (PTA; 12 patients) in our foot clinic during 2013-2016 and 19 healthy controls were included into the study. TcPO2 measurement was used as a standard method of non-invasive evaluation of limb ischemia. MRS examinations were performed using the whole-body 3T MR system 1 day before and 3 months after the procedure. Subjects were examined in a supine position with the coil fixed under the m. gastrocnemius. MRS parameters were obtained at rest and during the exercise period. Rest MRS parameters of oxidative muscle metabolism such as phosphocreatine (PCr), inorganic phosphate (Pi), phosphodiesters (PDE), adenosine triphosphate (ATP), dynamic MRS parameters such as recovery constant PCr (τPCr) and mitochondrial capacity (Qmax), and pH were compared between patients and healthy controls, and also before and 3 months after revascularization.
Patients with CLI had significantly lower PCr/Pi (p < 0.001), significantly higher Pi and pH (both p < 0.01), significantly lower Qmax and prolonged τPCr (both p < 0.001) in comparison with healthy controls. We observed a significant improvement in TcPO2 at 3 months after revascularization (from 26.4 ± 11.7 to 39.7 ± 17.7 mm Hg, p < 0.005). However, the rest MRS parameters did not change significantly after revascularization. In individual cases we observed improvement of dynamic MRS parameters. There was no correlation between MRS parameters and TcPO2 values.
Results of our study show impaired oxidative metabolism of calf muscles in patients with CLI in comparison with healthy controls. We observed an improvement in dynamic MRS parameters in individual cases; this finding should be verified in a large number of patients during longer follow-up.Key words: autologous cell therapy - critical limb ischemia - diabetic foot - MR spectroscopy.
One of the most serious complications of the diabetic foot (DF) is a major amputation, which is associated with poor patient prognosis. The occurrence of major amputations may be influenced by a ...variety of factors including deep infection caused by resistant pathogens.The aims of our study were to compare the incidence of major amputations in podiatric center, characteristics of amputated patients with the DF and other factors contributing to major amputations in last decade.
We included into our study all patients hospitalized for the DF in our center whose underwent major amputations from 9/2004 to 9/2006 (group 1) and from 9/2013 to 9/2015 (group 2). Risk factors such as severity of DF ulcers based on Texas classification, duration of previous anti-biotic therapy, the presence and severity of peripheral arterial disease (PAD) according to Graziani classification, the number of revascularizations, renal failure/hemodialysis, osteomyelitis, infectious agents found before amputations and their resistance were compared between the study groups.
During the 1st study period (9/2004-9/2006) 373 patients were hospitalized for the DF, of whom 3.2 % underwent major amputation (12/373 - group 1), during the 2nd study period (9/2013-9/2015) 376 patients, of whom 5.1 % absolved major amputation (19/376 - group 2). As the numbers of major amputations as their indications were similar in both study groups. The study groups did not differ significantly in the age, BMI, duration and type of diabetes, duration of DF and severity of DF ulcers, the presence of renal failure/hemodialysis, osteomyelitis and PAD. Group 2 had milder forms of PAD by Graziani classification (4.4 ±1.4 vs 5.7 ± 0.9; p = 0.012) and a higher number of revascularizations before major amputations (2.5 ± 1.5 vs 1 ± 1; p = 0.003) compared to the group 1. These patients were significantly longer treated by antibiotics (5.4 ± 2.4 vs 2.5 ± 2 months; p = 0.002) and underwent more resections and minor amputations (3.1 ± 2.1 vs 0.9 ± 0.5; p = 0.0004) before major amputations in contrast to the group 1. There was a trend to higher incidence of Gram-negatives (65.1 % vs 61.5 %; NS) with a predominance of Enterobacteriacae species (60.7 % vs 56 %; NS) and a trend to the increase of Pseudomonas (25 % vs 18.8 %; NS) and Enterococci sp. (46.7 % vs 20 %; NS) in the group 2 compared to the group 1. The incidences as of MRSA, multidrug resistant Pseudomonas sp. of other resistant microbes were similar in both study groups.
The incidence of major amputations in patients hospitalized for the DF remains unchanged during the last decade. The therapy of factors leading to amputations has evidently intensified. This is in accordance with the latest international recommendations for the therapy of DF. In the future, it is appropriate to focus on the improvement of detection and treatment of infection and ischemia in such risk group of patients.Key words: diabetic foot - major amputation.
Charcot Foot in Diabetes Rogers, Lee C; Frykberg, Robert G; Armstrong, David G ...
Diabetes care,
09/2011, Letnik:
34, Številka:
9
Journal Article
Recenzirano
Odprti dostop
The diabetic Charcot foot syndrome is a serious and potentially limb-threatening lower-extremity complication of diabetes. First described in 1883, this enigmatic condition continues to challenge ...even the most experienced practitioners. Now considered an inflammatory syndrome, the diabetic Charcot foot is characterized by varying degrees of bone and joint disorganization secondary to underlying neuropathy, trauma, and perturbations of bone metabolism. An international task force of experts was convened by the American Diabetes Association and the American Podiatric Medical Association in January 2011 to summarize available evidence on the pathophysiology, natural history, presentations, and treatment recommendations for this entity.
Background: Autologous cell therapy (ACT) is the last option for patients with no-option chronic limb-threatening ischemia (NO-CLTI) and severe pain. The aim of our study was to assess the impact of ...ACT on a patient’s quality of life, chronic pain and depression using standardized questionnaires.
Methods: Forty patients with NO-CLTI were randomized and divided into groups treated initially with ACT (iACT, n=20) or standard conservative therapy (iST, n=16); 4 patients dropped out of the study. After 3 months, those in the standard therapy (ST) group were switched to (cell therapy crossover). All patients filled out the standardized EQ-5D questionnaire assessing their quality of life. Pain was evaluated using a special questionnaire including the Visual Analogue Scale (VAS) and Wong-Baker Faces (WB). The questionnaires were evaluated before randomization; in the iST group at 3 months after ST and then at 3 months after ACT.
Results: Pain was significantly reduced in the iACT group after 3 months compared to baseline in both VAS and WB scores (both p<0.001); in the iST group, we observed even worsening of both pain scores without a significant difference (NS). After the cell therapy crossover of in the iST group, both pain scores increased significantly after 3 months (both p<0.001). Quality of life measured by EQ-5D was improved after 3 months of ACT (p<0.001) while not changing in the iST group after 3 months of ST (NS). After the crossover to ACT, quality of life was significantly improved also in the iST group (p<0.001). We observed a trend in towards a decrease in depression rate after 3 months of iACT from 45 to 33%, whereas the depression rate was slightly increased after 3 months of ST (from 56 to 61%) to decrease from 56 to 18% in the iST group after cell therapy crossover (all NS).
Conclusion: Our study showed significant pain reduction in NO-CLTI patients after ACT; this treatment also led to a decrease in depression rate and overall improvement in their quality of life.
Disclosure
J. Husáková: None. R. Bem: None. A. Nemcova: None. V. Fejfarova: None. A. Jirkovska: None. M. Dubsky: None.
Funding
Ministry of Health of the Czech Republic (16-27262A); Project for Development of Research Organization (00023001); IKEM, Prague, Czech Republic
Background: Autologous cell-therapy (ACT) is a new treatment method for patients with diabetes and no-option chronic limb-threatening ischemia (NO-CLTI). We aimed to assess the impact of ACT on CLTI ...in comparison with standard treatment (ST) in a randomized controlled trial.
Methods: Forty diabetic patients with NO-CLTI were randomized to receive either cell therapy (n=20) or standard conservative therapy (n=16); 4 patients dropped out of the study. After 3 months, those in the ST group were switched to ACT (cell therapy crossover). The effect on ischemia and diabetic foot was assessed by changes in transcutaneous oxygen pressure (TcPO2) and the number of healed patients at 3 months. Amputation rates and amputation-free survival (AFS) were assessed at 3 months and then during 12-month follow-up.
Results: TcPO2 increased significantly in the ACT group after 1 and 3 months (both p<0.001) whereas TcPO2 in the control group remained unchanged (NS). After the crossover to cell therapy in patients of the ST group, we observed a significant increase in TcPO2 at 1 and 3 months after the injection of ACT (p=0.036 and p<0.001, respectively). We also observed significantly more healed patients at 3 months in the ACT group compared to the ST group (p=0.01). The rates of major amputation and AFS at 3 months were not significantly different between the ACT and ST groups (both NS). In Kaplan-Meier estimate, patients treated initially by ACT showed a trend towards higher AFS rates compared to those treated initially by ST who received ACT after the 3-month delay, but without a significant difference (65 vs. 43.8%).
Conclusions: Our study showed that ACT in patients with no-option CLTI and diabetic foot significantly improved limb ischemia and wound healing when compared to standard conservative therapy, without influencing amputation rates and with a trend to higher 1-year AFS in comparison with delayed ACT treatment in ST group.
Disclosure
M. Dubsky: None. R. Bem: None. A. Nemcova: None. J. Husáková: None. V. Fejfarova: None. A. Jirkovska: None. K. Sutoris: None.
Funding
Ministry of Health of the Czech Republic (16-27262A, 00023001)
Our aim was to comprehensively estimate the incidence of diabetic foot ulcer (DFU) recurrence and corresponding risk factors in two cohorts.
Prospective data from patients with active DFU from two ...diabetes centres in Germany (GER, n = 222) and the Czech Republic (CZ, n = 99) were analysed. Crude cumulative incidences were obtained. Additionally, time to recurrence and risk factors were investigated using multivariate Cox models.
69%(154) of patients in GER and 70%(69) in CZ experienced at least one DFU recurrence; 25%(56) in DEU and 15%(15) in CZ died; 5%(11) and 9%(9) were lost to follow-up. The crude cumulative incidence in the first year was 28% in GER and 25% in CZ; 68%/70% within ten years, and 69%/70% in 15 years. In GER, renal replacement therapy was associated with shorter time to recurrence (HR = 3.71, 95%CI:1.26–10.87); no history of DFU before the index lesion with longer time to recurrence (HR = 0.62, 0.42–0.92). In CZ, type 2 diabetes (HR = 2.57, 1.18–5.62) and index ulcer treatment by minor amputation (HR = 2.11, 1.03–4.33) were associated with shorter time to recurrence.
Cumulative DFU recurrence was approximately 70% in 15 years in both cohorts. We found a significantly higher risk of future recurrence in patients having a consecutive ulcer compared with the first ever ulcer.
Diabetic foot infections are frequently polymicrobial. The lower tissue concentration of systemically administered antibiotics in diabetic patients was reported. Collatamp(®)EG (Syntacoll GmbH ...Saal/Donau, Germany) is a bioabsorbable, gentamicin impregnated collagen spongeused for local treatment. The aim of this randomized trial was to assess influence of gentamicin-collagen sponge applied to a wound on surgical outcomes after minor amputations in diabetic patients.
Fifty diabetic patients indicated for minor amputation in 2009 at our surgery department were included in the study. Patients were pre-operatively randomised into two groups. Twenty-five patients in group A were treated with gentamicin impregnated collagen sponge applied into wound peri-operatively while 25 patients in group B had minor amputation without gentamicin sponge.
There was no significant difference in the demographic data, procedures performed, diabetes duration and peripheral vascular disease severity between the groups. The median glycosylated haemoglobin was 6.0% (range: 4.6-9.5%) in group A and 6.2% (range: 4.0-8.4%) in control group B (non-significant). Median TcPO2 level was 44 (range: 13-67) in group A and 48 (range: 11-69) in control group B (non-significant). The median of wound healing duration in group A was 3.0 weeks (range: 1.7-17.1 weeks) compared to 4.9 weeks (range: 2.6-20.0 weeks) in control group B. This was with a statistically significant difference (p < 0.05).
Application of gentamicin impregnated collagen sponge shortened wound healing duration after minor amputations in diabetic patients by almost 2 weeks.
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