P. Holstein

High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study

Aims/hypothesisLarge clinical studies describing the typical clinical presentation of diabetic foot ulcers are limited and most studies were performed in single centres with the possibility of selection of specific subgroups. The aim of this study was to investigate the characteristics of diabetic patients with a foot ulcer in 14 European hospitals in ten countries.MethodsThe study population included 1,229 consecutive patients presenting with a new foot ulcer between 1 September 2003 and 1 October 2004. Standardised data on patient characteristics, as well as foot and ulcer characteristics, were obtained. Foot disease was categorised into four stages according to the presence or absence of peripheral arterial disease (PAD) and infection: A: PAD −, infection −; B: PAD −, infection +; C: PAD +, infection −; D: PAD +, infection +.ResultsPAD was diagnosed in 49% of the subjects, infection in 58%. The majority of ulcers (52%) were located on the non-plantar surface of the foot. With regard to severity, 24% had stage A, 27% had stage B, 18% had stage C and 31% had stage D foot disease. Patients in the latter group had a distinct profile: they were older, had more non-plantar ulcers, greater tissue loss and more serious comorbidity.Conclusions/interpretationAccording to our results in this European cohort, the severity of diabetic foot ulcers at presentation is greater than previously reported, as one-third had both PAD and infection. Non-plantar foot ulcers were more common than plantar ulcers, especially in patients with severe disease, and serious comorbidity increased significantly with increasing severity of foot disease. Further research is needed to obtain insight into the clinical outcome of these patients.

Decreasing incidence of major amputations in people with diabetes

Aims/hypothesis. To assess the results of the strategy used in avoiding major amputations in patients with diabetes mellitus. Methods. A retrospective study for the years 1981 to 1995 in a central district hospital in Copenhagen with a catchment area population of about 178,000. Results. There were 463 major leg amputations and the incidence decreased from 27.2 to 6.9/100,000 population (75 %). The decrease in patients with Type I (insulin-dependent) diabetes mellitus was from 10.0 to 4.1 (59 %) and in Type II (non-insulin-dependent) diabetes mellitus from 17.2 to 2.8/100,000 people (84 %). Analysis showed that the diabetic population remained constant despite a considerable fall in the number of older people. During the study period infra-popliteal arterial bypass was introduced for the treatment of critical lower limb ischaemia and in diabetic patients the number of bypasses increased from zero to 13/100,000 population. The total number of revascularisation procedures in people with diabetes increased from 2.6 to 19.2/ 100,000 population. Moreover, a multidisciplinary diabetic foot clinic was established. Conclusion/interpretation. A 75 % reduction in the incidence of major amputations coincided with a sevenfold increase in revascularization procedures and the establishment of a multidisciplinary diabetic foot clinic suggesting these measures are important in the prevention of diabetic leg amputations. [Diabetologia (2000) 43: 844–847]

Resource utilisation and costs associated with the treatment of diabetic foot ulcers. Prospective data from the Eurodiale Study

Aims/hypothesisThe aim of the present study was to investigate resource utilisation and associated costs in patients with diabetic foot ulcers and to analyse differences in resource utilisation between individuals with or without peripheral arterial disease (PAD) and/or infection.MethodsData on resource utilisation were collected prospectively in a European multicentre study. Data on 1,088 patients were available for the analysis of resource use, and data on 821 patients were included in the costing analysis. Costs were calculated for each patient by multiplying the country-specific direct and indirect unit costs by the number of resources used from inclusion into the study up to a defined endpoint. Country-specific costs were converted into purchasing power standards.ResultsResource use and costs varied between outcome groups and between disease severity groups. The highest costs per patient were for hospitalisation, antibiotics, amputations and other surgery. All types of resource utilisation and costs increased with the severity of disease. The total cost per patient was more than four times higher for patients with infection and PAD at inclusion than for patients in the least severe group, who had neither.Conclusions/interpretationImportant differences in resource use and costs were found between different patient groups. The costs are highest for individuals with both peripheral arterial disease and infection, and these are mainly related to substantial costs for hospitalisation. In view of the magnitude of the costs associated with in-hospital stay, reducing the number and duration of hospital admissions seems an attractive option to decrease costs in diabetic foot disease.

Delivery of care to diabetic patients with foot ulcers in daily practice: results of the Eurodiale Study, a prospective cohort study

Aims  To determine current management and to identify patient‐related factors and barriers that influence management strategies in diabetic foot disease.

Differences in minor amputation rate in diabetic foot disease throughout Europe are in part explained by differences in disease severity at presentation.

Diabet. Med. 28, 199–205 (2011)

Wound healing in above-knee amputations in relation to skin perfusion pressure.

In 59 above-knee amputations healing of the stumps was correlated with the local skin perfusion pressure (SPP) measured preoperatively as the external pressure required to stop isotope washout using 1318-- or 125I--antipyrine mixed with histamine. Out of the 11 cases with an SPP below 30 mmHg no less than nine (82 per cent) suffered severe wound complications. Out of the 48 cases with an SPP above 30 mmHg severe wound complications occurred in only four cases (8 per cent). The difference in wound complication rate is highly significant (P less than 0.01). The postoperative SPP measured on the stumps was on average only slightly and insignificantly higher than the preoperative values, explaining why the preoperative values related so closely to the postoperative clinical course. We conclude that the SPP can be used to predict ischaemic wound complications in above-knee amputations as has previously been shown to be the case in below-knee amputations.

Achilles tendon lengthening, the panacea for plantar forefoot ulceration?

Recent reports on Achilles tendon lengthening (ATL) have documented rapid healing of chronic plantar neuropathic forefoot ulcers.

Healing of ulcers on the feet correlated with distal blood pressure measurements in occlusive arterial disease

The frequency of healing in subchronic ulcers in 66 feet in 62 patients with arterial occlusive disease was correlated with the systolic digital blood pressure (SDBP) and the systolic ankle blood pressure (SABP), both measured with a strain gauge, and with the skin perfusion pressure on the heel (SPPH) as measured with a photocell. Thirty-two patients (35 feet with ulcerations) had diabetes mellitus. The treatment was conservative. In 42 feet the ulcers healed after an average period of 5.8 months; in 24 feet major amputation became necessary after an average of 4.3 months. The frequency of healing correlated significantly with the three distal blood pressure parameters investigated, the closest correlation being with the SDBP measured at the final examination, i.e. just after healing of the ulcer or just before an inevitable major amputation. Of the 22 cases with SDBP below 20 mmHg only two cases (9%) healed. Of the 11 cases with SDBP of 20 to 29 mmHg seven cases (64%) healed and of the 33 cases with SDBP of 30 mmHg or above all cases (100%) healed. There was no significant difference between the 35 diabetic feet and the 31 non-diabetic feet as regards the healing rates, although infection and peripheral neuropathy were frequent in the diabetic group. The data show that the systolic digital blood pressure is a particularly valuable prognostic parameter.

Predictors of Lower-Extremity Amputation in Patients With an Infected Diabetic Foot Ulcer

OBJECTIVE Infection commonly complicates diabetic foot ulcers and is associated with a poor outcome. In a cohort of individuals with an infected diabetic foot ulcer, we aimed to determine independent predictors of lower-extremity amputation and the predictive value for amputation of the International Working Group on the Diabetic Foot (IWGDF) classification system and to develop a risk score for predicting amputation. RESEARCH DESIGN AND METHODS We prospectively studied 575 patients with an infected diabetic foot ulcer presenting to 1 of 14 diabetic foot clinics in 10 European countries. RESULTS Among these patients, 159 (28%) underwent an amputation. Independent risk factors for amputation were as follows: periwound edema, foul smell, (non)purulent exudate, deep ulcer, positive probe-to-bone test, pretibial edema, fever, and elevated C-reactive protein. Increasing IWGDF severity of infection also independently predicted amputation. We developed a risk score for any amputation and for amputations excluding the lesser toes (including the variables sex, pain on palpation, periwound edema, ulcer size, ulcer depth, and peripheral arterial disease) that predicted amputation better than the IWGDF system (area under the ROC curves 0.80, 0.78, and 0.67, respectively). CONCLUSIONS For individuals with an infected diabetic foot ulcer, we identified independent predictors of amputation, validated the prognostic value of the IWGDF classification system, and developed a new risk score for amputation that can be readily used in daily clinical practice. Our risk score may have better prognostic accuracy than the IWGDF system, the only currently available system, but our findings need to be validated in other cohorts.

Optimal Organization of Health Care in Diabetic Foot Disease: Introduction to the Eurodiale Study

This article describes the rationale and protocol of a large data collection study in patients with new diabetic foot ulcers by the Eurodiale study group, a consortium of centers of expertise in the field of diabetic foot disease within Europe. This study is a multicenter, observational, prospective data collection study. Its main aim is to determine the major factors determining clinical outcome and outcome in terms of health-related quality of life and health care consumption. Between September 1, 2003, and October 1, 2004, in 14 European centers, all consecutive patients with diabetes and a new foot ulcer were included in the study and followed until the end point or for a maximum of 1 year. End points were healing of the foot, major amputation, or death. Data were collected on patient, foot, and ulcer characteristics and on diagnostic and management procedures. Furthermore, data were collected on health care organization, quality of life, and resource use. A total of 1232 patients were included in the study. Sixty-three percent of the patients were referred by their general practitioner or were self-referrals. Twenty-seven percent of the patients were admitted at the time of inclusion; 1088 patients were followed until the end point. “Optimal Organization of Health Care in Diabetic Foot Disease” is one of the first large multicenter studies in the field of diabetic foot disease on clinical presentation, clinical outcome, quality of life, resource utilization, and health care organization and their interrelationships. These data will provide us with new insights that enable us to improve care for these patients and guide the development of new studies in this area. The results of this study are the subject of a separate presentation.