Structured health care for subjects with diabetic foot ulcers results in a reduction of major amputation rates.

OBJECTIVE: We tested the effects of structured health care for the diabetic foot in one region in Germany aiming to reduce the number of major amputations. RESEARCH DESIGN AND METHODS: In a prospective study we investigated patients with diabetic foot in a structured system of outpatient, in-patient and rehabilitative treatment. Subjects were recruited between January 1st, 2000 and December 31, 2007. All participants underwent a two-year follow-up. The modified University of Texas Wound Classification System (UT) was the basis for documentation and data analysis. We evaluated numbers of major amputations, rates of ulcer healing and mortality. In order to compare the effect of the structured health care program with usual care in patients with diabetic foot we evaluated the same parameters at another regional hospital without interdisciplinary care of diabetic foot (controls). RESULTS: 684 patients with diabetic foot and 508 controls were investigated. At discharge from hospital 28.3% (structured health care program, SHC) vs. 23.0% (controls) of all ulcers had healed completely. 51.5% (SHC) vs. 49.8% (controls) were in UT grade 1.Major amputations were performed in 32 subjects of the structured health care program group (4.7%) vs. 110 (21.7%) in controls (p<0.0001). Mortality during hospitalization was 2.5% (SHC) vs. 9.4% in controls (p<0.001). CONCLUSIONS: With the structured health care program we achieved a significant reduction of major amputation rates by more than 75% as compared to standard care.

SUMMIT registry: one-year outcomes after implantation of the EPIC self-expanding nitinol stent in the femoropopliteal segment.

PURPOSE: To evaluate the efficacy and safety of the EPIC self-expanding nitinol stent in patients with femoropopliteal occlusive disease. METHODS: The prospective, multicenter, nonrandomized SUMMIT study (ClinicalTrials.gov identifier NCT01336101) enrolled 100 patients (76 men; mean age 67.6 years) with symptomatic de novo femoropopliteal disease undergoing angioplasty and subsequent implantation of EPIC stents from April 2011 to October 2011. The mean lesion length was 69.5±40.5 mm; 29 of the lesions were total occlusions. Clinical examination and duplex sonography were prospectively performed after 6 and 12 months. The primary endpoint was in-stent restenosis as assessed by duplex ultrasound (peak systolic velocity ratio ≥2.5). Further outcome measures were patency rates, improvement in the Rutherford category and ankle-brachial index (ABI), as well as stent integrity based on plain radiography. RESULTS: A residual stenosis <30% was achieved in all procedures. The primary patency rates were 96.8% after 6 months and 85.1% at 1 year. The secondary patency rates were 97.9% and 91.2% at the same intervals. The 1-year binary >50% restenosis rate was 15.7%. Freedom from target lesion revascularization at 1 year was 92.3%. Between baseline and the 12-month follow-up, the mean ABI increased from 0.73 to 0.96, and the mean Rutherford category decreased from 2.9 to 1.0 (p<0.001 for both comparisons). Plain radiographs from 86 patients at the 12-month examination confirmed the absence of stent fractures. CONCLUSION: The outcome of the SUMMIT registry demonstrates that the EPIC self-expanding nitinol vascular stent is a safe and effective device for treating peripheral artery disease in the femoropopliteal segment.

Improving major amputation rates in the multicomplex diabetic foot patient: focus on the severity of peripheral arterial disease.

OBJECTIVE: Peripheral arterial disease (PAD), as well as diabetic neuropathy, is a risk factor for the development of diabetic foot ulcers. The aim of this study was to evaluate differences and predictors of outcome parameters in patients with diabetic foot by stratifying these subjects according to the severity of PAD. RESEARCH DESIGN AND METHODS: In a prospective study, patients with new diabetic foot ulcers have been treated and investigated by structured healthcare. Subjects were recruited between 1 January 2000 and 31 December 2007. All study participants underwent a 2-year follow-up observation period. The patients underwent a standardized examination and classification of their foot ulcers according to a modification of the University of Texas Wound Classification System. The severity of PAD was estimated by measurement of the ankle brachial index (ABI) and the continuous wave Doppler flow curve into undisturbed perfusion (0.9 < ABI < 1.3), compensated perfusion (0.5 < ABI < 0.9), decompensated perfusion (ABI < 0.5) and medial arterial calcification. RESULTS: A total of 678 patients with diabetic foot were consecutively included into the study (69% male, mean age 66.3 ± 11.0 years, mean diabetes duration 15.8 ± 10.2 years). Major amputations (above the ankle) were performed in 4.7% of the patients. 22.1% of these subjects had decompensated PAD. These subjects had delayed ulcer healing, higher risk for major amputation [odds ratio (OR) 7.7, 95% confidence interval (CI) 2.8-21.2, p < 0.001] and mortality (OR 4.9, 95 % CI 1.1-22.1, p < 0.05). CONCLUSION: This prospective study shows that the severity of PAD significantly influences the outcome of diabetic foot ulcers regarding to wound healing, major amputation and mortality.

Noninvasive management of the diabetic foot with critical limb ischemia: current options and future perspectives.

Foot ulcers are a major complication in patients with diabetes mellitus and involve dramatic restrictions to quality of life and also lead to enormous socio-economical loss due to the high amputation rate. The poor and slow wound healing is often aggravated by the frequent comorbidity of foot ulcers with peripheral arterial disease, making the treatment of this condition even more complicated. While the local treatment of foot ulcers is mainly based on mechanical relief and prevention or treatment of infection, improving perfusion of the impaired tissue remains the major challenge in peripheral arterial disease. While focal arterial stenosis is the domain of interventional angioplasty or vascular surgery, patients with critical limb ischemia and lacking options for revascularization have a much worse prognosis, because current treatment options avoiding amputation are scarce. However, based on recent research efforts, there is rising hope for promising and more-effective therapeutic approaches for these patients. Here, we discuss the current improvements of established therapies aimed at an improvement of limb perfusion, as well as the development of novel cutting-edge therapies based on stem-cell technology. The experiences of a 'high-volume center' for treatment of diabetic foot syndrome with a current major amputation rate of 4% are discussed.