Data depicting the outcome of different treatment regimes for the diabetic foot are heterogeneous throughout literature. Currently, prospective long-term studies regarding diabetic foot management are almost scarce. We therefore conducted this prospective observational study with an 8 year inclusion and a two-year post-treatment observation period. The central objective of the project, a significant reduction of major amputation in diabetic foot patients, has been achieved by introducing a structured health care program for the diabetic foot. The number of amputations above the ankle in this study was 4.7% at the end of the acute hospital treatment period and, thus, very low, in comparison to the control group, treated by usual care of diabetic foot.
This is comparable to the data published by Canavan et al.  from the South Tees region in England, demonstrating that an intensified care for patients with diabetic foot results in a drastic reduction of lower extremity amputation (LEA) rates. In this study, the relative risk of a person with diabetes undergoing LEA declined from 46 times of that of a person without diabetes to 7.7 at the end of a 5 year follow up period from 1995 to 2000 and comparable data were published by Krishnan et al. .
In a prospective study of a cohort of 291 patients hospitalized for diabetic foot infection at 38 French centres, a LEA rate of 35% during hospital treatment was documented. During the 1 year follow – up LEA rate increased to 48% .
The results of centers specialized in the treatment of patients with diabetic foot in Great Britain (Manchester) and the US (San Antonio) were reported by Oyibo et al. . In 1998 and 1999, this observational study comprised 194 patients. The wound data were classified according to the original UT-System.
Only 26% of the ulcers were described to be neuroischemic. The great majority of findings (67%) were neuropathic ulcers. According to these data, a high healing rate should have been expected. However, 14% of the patients underwent LEA due to non-healing ulcers. Four percent of the patients died, and 16% had persistent ulcers at the end of the study. Altogether, 65% of the initially existing ulcers healed completely. The likelihood of calf amputations was 15 times higher for patients with diabetic foot affected by ischemia or infection compared to patients without these conditions.
These data are comparable well to our results presented here especially because the UT system or the modified UT system was used in these studies.
In the EURODIALE-Study, conducted at 14 hospitals in 10 European countries, a major amputation rate of 5.1% in 1229 patients was documented .
Severe limb ischemia, as defined by an ABI of <0.5, was present in 12% of these patients. In our study decompensated perfusion was found in 22% of all patients in the disease management program group.
Peripheral vascular disease (PAD) is significantly associated with reduced survival in foot ulcer patients.
Faglia et al.  addressed the problem of occlusive peripheral arterial disease in subjects with diabetic foot ulcers. From 1993 to 1995, 121 patients with diabetic foot were admitted consecutively to Milan University hospital. Angiography was carried out in 104 subjects. The most interesting data in this study was the extraordinary high rate of occlusive arterial disease. Only one out of 104 subjects did not have hemodynamically significant stenoses. Nearly half of the patients had stenoses in the popliteal and infrapopliteal axis only. Because neuropathy was also found to be very common too (90 subjects = 86.5%), the prevalent picture was the neuroischemic foot. Similary, more than 80% of all subjects in our study had neuroischemic diabetic foot. In 2009, the same group reported even more impressive data on 554 patients with critical limb ischemia (CLI) .
In these patients, peripheral angioplasty (PTA) was performed in 75% and bypass graft (BPG) in 21%. Neither PTA nor BPG were possible in 5% of the subjects.
LEA rate in this highly complicated group of patients was 13.4% (8% in PTA patients, 21% BPG and 59% in the subgroup that received no revascularisation). Comparable data were reported by Uccioli et al. . It can be concluded from these studies that the degree of PAD has a drastic effect on the outcome of diabetic foot therefore limiting the comparability of most of these studies performed at different centers.
The long-term outcome in terms of amputations and mortality in patients with new-onset diabetic foot ulcers in subgroups stratified by etiology was examined by Moulik et al. . Five-year mortality was 18%, 45% and 55% for neuropathic, neuroischemic and ischemic ulcers, respectively.
The rates of mortality also vary significantly between different studies, most likely due to differences in the proportion and degree of CLI, history of foot ulcer or amputation and impaired renal function.
The Milan group  evaluated new ulceration, new major amputation and survival rates of 115 subjects with diabetes hospitalized for foot ulceration from 1990 to 1993. One of the main results was the mortality rate of 44% during the follow-up period of 6.5 years. After two years, the mortality rate was around 15% regarding subjects without and more than 40% in subjects with major amputation. The overall mortality rate was 20% after two years. These data are comparable with the mortality rates reported in our present study.
Holstein and Sorensen  reported a retrospective study of 162 patients with diabetes with foot ulcers admitted to a vascular surgical department with a new multidisciplinary diabetic foot unit.
The survival rate after 24 months was 68% in subjects with diabetic foot due to peripheral neuropathy without the need for arterial reconstruction, 64% in patients with limb-threatening ischemia undergoing revascularization, and 16% in diabetic foot with limb-threatening ischemia without possible option for revascularization.
Williams et al.  recently have shown that the implementation of a multidisciplinary diabetic foot team into a department of vascular surgery was associated with improved outcomes for patients with diabetic foot. The improvements were not related to increased numbers of vascular procedures or hospitalizations, but coincide with greater proportion of patients attending this foot unit.
There is considerable variability in the reported incidence rates of amputation among different countries and various points in time [23–27]. In general a significant reduction in LEA in diabetic foot appears to be realized [28, 29]. As compared to the data reported in the literature with major amputation rates of 8-40%, the rate of 4.7% of major amputation in our patients treated by the structured health care program documents a significant improvement.
Armstrong et al.  reported that the frequency of major amputation increases with advanced wound progression as determined by the Wagner classification of lesions or with an infection (stage B according to UT system), or ischemia (stage C). A simultaneous occurrence of infection and ischemia (stage D) would further increase the likelihood for LEA.
Thus, if the wound extends to the bone and an infection and ischemia exist (Wagner grade 3 and higher) it is very likely that LEA will be necessary. However, due to the very small number of amputations, the data of our study do not confirm this.
The significantly higher age of the controls in our study may potentially affect wound healing, mortality and amputation rate. Therefore, the data were adjusted to age, PAD, history of CHD, hypertension, smoking and MA.
Moreover, as compared to the controls, the state of perfusion was significantly worse in the patients treated in the structured health care program. Therefore, the significantly higher rate of amputations (4.6-fold) in the control group of our study may not be related to age. Similarly, the increased mortality rate in the controls (3.8-fold) may not be attributed to age differences since both groups (controls/structured health care) did not differ with respect to their general and disease-related morbidity (Table 1).
Patients with diabetic complications and diabetic foot problems in particular are among the most complex and vulnerable of all patient populations and intensive effort is required in these patients in order to accomplish limb preservation [30, 31]. The implementation of the structured health care program by the means of a multidisciplinary diabetic foot team is essential to reduce LEA successful [28, 32].
The structured health care program for diabetic foot introduced here includes structured outpatient, inpatient and rehabilitative treatment. Since the major amputation rate of the control group without the structured health care program was about 5 times higher, we conclude that a the introduction of a structured health care program can significantly reduce the number of major amputations in patients with diabetic foot.