[Show abstract][Hide abstract] ABSTRACT: The diabetic foot (DF) is a complex pathology involving the lower limb of 8 to 10 million people around the world, and its prevalence is rising, creating a dramatic need for effective therapeutic answers. The multidisciplinary DF clinic has been proposed as a model to fight this complication from the International Working Group on Diabetic Foot (IWGDF) inside a more articulated 3-level organization strategy. The organization and technical aspects of this strategy, together with the characteristics of each of the 3 levels have been analyzed and described in the article, together with the aims and limitations of each of the levels to cope with a 3-dimensional pathology involving systemic, local, and logistic aspects. The implementation of this model in Europe produced positive results measured so far in at least 2 nationwide experiences, in Germany and in Italy, and it should be taken in account whenever health policies apply to the DF issue.
The International Journal of Lower Extremity Wounds 08/2014; 13(4). DOI:10.1177/1534734614545876 · 1.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: We evaluated the safety and efficacy of sulodexide, a biocompound of glycosamin-glicans, as adjunct medical therapy to percutaneous transluminal angioplasty (PTA) in diabetes mellitus (DM) patients with critical limb ischemia (CLI). We studied 27 consecutive DM patients with CLI successfully subjected to PTA who, on top of standard antiplatelet therapy, received sulodexide 25 mg bid, and were followed-up for 24 weeks, monitoring adverse events, transcutaneous oxygen tension (TcPO2), ankle-brachial pressure index, pain, and ulcer dimension. At the end of follow-up, ulcer healing, amputation rates, and cardiovascular risk profile of patients were evaluated. Patients were compared with a historical superimposable control group that was treated for the same indications in the same way as the study group, except for sulodexide inception. No differences in ulcer healing and amputation rates were found at the end of follow-up between the groups. In the study group, TcPO2 was significantly (P < .05) higher at the end of follow-up, and pain intensity was reduced more rapidly. Plasma fibrinogen and plasma creatinine concentration were significantly (P < .05) reduced in study group at the end of follow-up. No differences in adverse events were observed between the groups during follow-up. Our data suggest that sulodexide administration after PTA, on top of antiplatelet therapy, may improve the outcome of PTA in DM patients with CLI by improving microcirculatory function.
The International Journal of Lower Extremity Wounds 05/2014; 13(2). DOI:10.1177/1534734614534442 · 1.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVE: To retrospectively evaluate the agreement between the angiographic scores and the clinical outcomes after endoluminal revascularization in diabetic patients with Fontaine stage IV critical limb ischemia (CLI). METHODS: Clinical and procedural data were retrospectively collected of consecutive diabetic patients with Fontaine stage IV CLI who underwent percutaneous lower limb endoluminal revascularization from January 2009 to June 2011. Pre- and postprocedural angiographic images were retrospectively reviewed to classify lower limb arterial involvement according to four systems: (1) TransAtlantic Inter-Society Consensus [TASC] I; (2) TASC II; (3) Graziani's morphologic classification; and (4) Joint Vascular Society Council calf and foot scores. Foot lesions were graded according to the University of Texas wound classification system. Clinical results (healing, nonhealing, or major amputation) were compared with baseline clinical data and angiographic results. RESULTS: In the study period, 202 percutaneous procedures were performed, with an immediate technical success rate of 94%. Preprocedurally, the mean ± standard deviation calf and foot scores were 7.8 ± 1.6 and 7.3 ± 2.3, respectively; 132 patients (65%) were in Graziani's morphologic classes from 4 to 7; in 112 (55%) cases, TASC II was considered inapplicable, for the absence of femoropopliteal lesions; and finally, 93% of limbs were classified as TASC I type D lesions. After the procedure, mean calf and foot scores were 4.8 ± 2.3 and 5.9 ± 2.6, respectively, and 87% of cases were in Graziani's classes 1 and 2; TASC II was inapplicable in all cases, whereas 80% of cases remained TASC I type D lesions. Healing rate was 67% and major amputation rate was 4%. Among all the clinical and angiographic variables included in the analysis, only pre- and postprocedural foot scores were significantly associated to the clinical outcome (P < .05). CONCLUSIONS: Endoluminal revascularization represents a valuable treatment option in diabetic patients with CLI. TASC classifications are inadequate to describe peripheral arterial involvement in the vast majority of diabetic patients with CLI. Pre- and postprocedural foot scores represent the most significant angiographic parameters to evaluate treatment success.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 01/2013; 57(5). DOI:10.1016/j.jvs.2012.10.104 · 2.98 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Diabetic peripheral neuropathy (DPN), in all its different forms, is the most common long-term diabetes complication, affecting about half of all diabetic patients . The different clinical patterns that develop in diabetic patients are characterized by a remarkable heterogeneity regarding their symptoms, pattern of neurologic involvement, natural history, response to treatment, and pathologic alterations [2, 3].
[Show abstract][Hide abstract] ABSTRACT: To evaluate the outcomes of a multidisciplinary team working on diabetic foot (DF) patients with critical limb ischemia (CLI) in a specialized center, the authors retrospectively traced all the patients admitted in their department in 3 consecutive years with a diagnosis of CLI. From January 2006 to December 2008, 245 consecutive DF patients with CLI according the TransAtlantic interSociety Consensus II criteria were included in the study. Treatment strategy was decided by a team of diabetologists, inteventional radiologists, and vascular surgeons. Technical and clinical success, mortality, and ulcer recurrence were evaluated at 6 months and at a mean follow-up of 19.5 ± 13.4 months. Percutaneous transluminal angioplasty (PTA) was performed in 189 (77%) patients, whereas medical treatment, open surgical revascularization (OSR), and primary amputation were performed in 44 (18.3%), 11 (4.3%), and 1 (0.5%) patients, respectively. Revascularization was successful in 227/233 (97.4%) patients. At follow-up, the overall clinical success rate was 60.4%; it was significantly (P = .001) higher after revascularization (75.9%) compared with medical treatment (48.3%). During follow-up, surgical interventions in the foot were 1.5 ± 0.4 in those treated with PTA, 1.6 ± 0.5 in those treated with OSR, and 0.3 ± 0.8 in those receiving medical therapy (P < .05 compared with the others). Ulcer recurrence occurred in 29 (11.8%) patients: 4 (1.6%) in PTA, 2 (0.8%) in OSR, and 23 (9.4%) in the medical therapy group (P < .05). Major amputation rate was 9.3%, being significantly (P = .04) lower after revascularization (5.2%) compared with medical therapy alone (13.8%). Cumulative mortality rate was 10.6%. In conclusion, this study confirms the positive role of a PTA-first approach for revascularizing the complex cases of DF with CLI in a teamwork management strategy.
The International Journal of Lower Extremity Wounds 06/2012; 11(2):113-9. DOI:10.1177/1534734612448384 · 1.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The objective of this study was to assess the impact of a structured follow-up program on the incidence of diabetic foot ulceration (DFU) in high-risk diabetic patients.
A total of 1874 diabetic patients referred to the Diabetic Foot Unit of the University of Pisa were ranked based on the ulcerative risk score proposed by the International Consensus on Diabetic Foot. Out of 334 patients (17.8%) with a score ≥2, 298 accepted to participate in this prospective trial and were randomized into 2 groups: group A, which received standard treatment, and group B, in which the patients received, as a part of a structured prevention program, custom-made orthesis and shoes. Incidence of new DFUs was observed for no less than 1 year and in a subset of patients after 3 and 5 years, respectively. Incidence of new DFUs and recurrences were considered as primary endpoints to establish the effectiveness of the program; costs were also compared.
Among the patients enrolled in this follow-up analysis, 46% had neuropathy and deformities, 20% had previous ulceration, 25% had previous minor amputation, and 9% had neuro-osteoarthropathy. During the first 12-month follow-up, 11.5% of patients in group B developed a DFU compared with 38.6% in group A (P < .0001). In the extended follow-up, the cumulative incidence of ulcer in group B compared with group A was 17.6% versus 61% (P < .0001) after 3 years and 23.5% versus 72% (P < .0001) after 5 years, respectively. The net balance at the end of the follow-up was highly in favor of the prevention program, with a saving of more than €100 000 per year.
The implementation of a structured follow-up with the use of orthesis and shoes can reduce the incidence of DFU in diabetic patients who are at high ulcerative risk and its related costs.
The International Journal of Lower Extremity Wounds 02/2012; 11(1):59-64. DOI:10.1177/1534734612438729 · 1.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Samples from 1295 patients with diabetic foot infection were evaluated; 4332 samples were collected with an average of 3.3 samples per patient. Fifty-seven percent of patients had a 2B ulcer and 23% had a 3B ulcer according to Texas University Classification. In 64.2% of samples collected at first visit an etiologic agent was identified. About 40% of the positive samples were polymicrobial. Gram positive bacteria were more frequently isolated (52.6%), Staphylococcus aureus was the most frequently isolated single agent (29.9%) and MRSA was 22% of S. aureus. Enterococcus spp., mainly Enterococcus faecalis, were 9.9%, all vancomycin susceptible except 2 isolates. Streptococci were 4.6%, more than 60% Streptococcus agalactiae. Gram negative rods were 40.6%, with enterobacteria 23.5% and Pseudomonas aeruginosa 10.3%. Anaerobes were only 0.3%, probably due to culture methods applied in our laboratory. Cotrimoxazole, rifampin and doxycycline were still active against S. aureus. ESBL producers, among enterobacteria, were 10%, mainly Escherichia coli and Proteus spp. Only colistin had a rate of susceptibility against P. aeruginosa above 90%. Levofloxacin had the best clinical activity with respect to the other quinolones, but when it failed, selected more resistant strains with respect to moxifloxacin among S. aureus and with respect to ciprofloxacin among P. aeruginosa.
Diabetes research and clinical practice 08/2011; 94(1):133-9. DOI:10.1016/j.diabres.2011.07.017 · 2.54 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Diabetic complications in the lower extremities, especially those secondary to diabetic macroangiopathy, have increasingly become a clinical emergency, given the high prevalence and progression of the disease. Until recently, the only approach to treating advanced stage disease was medical therapy and major amputation; however, the advent of revascularization procedures has radically improved the prognosis of patients with critical lower limb ischemia. In this setting, iloprost holds a dual position: as first-choice therapy in patients ineligible for revascularization and as complementary therapy in candidates for surgical or endovascular revascularization.