In Germany, legislation demands measurement of the quality of management of outpatient and inpatient facilities. In 2003, the German Working Group on the Diabetic Foot developed certification requirements for diabetic foot centres. These certification requirements established proceedures by which specialised centres for the treatment of the diabetic foot syndrome could verify their management quality. In addition, this certification fulfils the demands of the 2006 IDF Global Guideline for Type 2 Diabetes (IDF Clinical Guidelines Task Force, 2006). The goal was to establish comparable diabetic foot centers with clearly defined treatment structures.
Conditions for the certification are quality parameters of the facility’s structure, treatment procedures and patient outcomes (Box 1; Schaper et al, 2003; IDF Clinical Guidelines Task Force, 2006). Structural quality was based on the qualifications of staff, the facility’s spatial conditions and a minimum provision of equipment. Staff members of certified centres must visit each other. Also assessed are the application of available guidelines and documentation systems, the establishment of a multidisciplinary team approach between the facility’s staff and other experts involved.
Indicators of outcome quality include:
- rate of amputation (major and minor)
- vascular intervention (surgery, percutaneous transluminal angioplasty)
- death rate
- clinical admission
- foot status 6 months after first documentation of a diabetic foot condition.
Rules for certification were published as part of the annual meeting of the German Working Group on the Diabetic Foot and are also available from the working group’s website (http://www.ag-fuss-ddg.de/ [accessed 25.06.2007]). All parameters are checked, presented and benchmarked in an open session of the working group (Müller et al, 2006; Lobmann et al, 2007).
Interested centres submitted applications for assessment of inpatient or outpatient diabetic foot care. Applications were then checked by a certification committee for correctness and completeness, a process that focuses on the structural equipment, reports of hospitalisations and treatment evaluation.
For the evaluation, each centre documented 30 consecutively seen individuals with diabetic foot lesions. An evaluation of the outcomes was performed 6 months after the initial presentation of each individual.
Details collected as part of the evaluation included:
- patient date of birth
- date of first visit
- classification of the lesion or Charcot
- date of re-evaluation
- occurrence of major and minor amputation
- record of any other procedures
- record of hospitalisation
- classification of the target ulcer after 6 months
Data from 130 certified centres are presented: 84 centres treated outpatients and 46 centres inpatients. A total of 3864 individuals were evaluated. Table 1 shows a summary of the results stratified by care setting and incidence of outcomes.
Figure 1 shows the number of occurrences of diabetic foot ulcers according to their Wagner classification at baseline and after 6 months. At the 6-month follow-up assessment, a substantial improvement could be seen: more than half (54.6 %) of all participants experienced complete healing of the documented lesions and only 17 % were classified as Wagner stage 2 or above. The changes in the ulcer severity over six months for each care setting are shown in Table 2.
There was a distinct difference between the distribution of cases treated in outpatient centres and those admitted as inpatients. The outpatient foot centres saw a majority of Wagner stage 1 and 2 cases (75.1 %), whereas those with stage 4 ulcers were treated primarily as inpatients. Individuals with Wagner stage 1 ulcers were rarely admitted to inpatient care.
Osteoarthropathy, or Charcot foot, was recorded in 553 (14.3 %) of the cases examined. These individuals can be categorised further using the Sanders patterns classification, based on the anatomical location of the arthropathy (see Table 3).
The results of the evaluation indicate a low level of major (above-ankle) amputations – only 170 (4.4 %) were recorded over the study period. Substantially more people underwent a minor (below-ankle) amputation (666; 17.2 %).
This evaluation included only facultative information on the type of minor amputation and vascular reconstructive measures; an in-depth statistical analysis of the minor amputations was therefore not possible.
The rate of hospitalisation proved to be an important parameter, with 1378 people requiring admission. Of these 1378, 661 were initially treated in outpatient centres (a referral rate of 26.6 %) and 717 were later re-hospitalised.
In general, a significant improvement, or even complete wound healing, could be seen in people treated in the outpatient foot clinics as long as the lesion was still in Wagner stage 1–4 at the initial presentation. As expected for Wagner stage 5 ulcerations, there was no substantial improvement and, in most cases, surgical intervention – usually a major amputation – was necessary.
Of the cases examined, an infection was diagnosed in 33.7 % of inpatients and 34.3 % of outpatients.
The rates of arterial revascularisation were comparable between the inpatient and outpatient groups: 14.6 % and 14.1 %, respectively. However, Armstrong stage D occured significantly more often in the inpatient group (45.4 %) compared with the outpatient group (25.3 %).
In total, 179 (4.6 %) people died during the observation time and the mortality was significantly higher for inpatients (7 % versus 3.3 %; P < 0.001).
These data represent the first analyses of the treatment outcomes of diabetic foot lesions in specialised centers in Germany.
The relatively high rates of Charcot foot reflect the selective nature by which people are referred to diabetes specialists.
The poor outcomes associated with lesions classified as Wagner 4 and 5 lesions demand early diagnosis and treatment to prevent progression of the diabetic foot lesion and elevated rates of complications.
Owing to the incidence of arterial occlusive disease, the rate of revascularisation procedures seems to be relatively low. The forthcoming evaluation sheet from the working group will give a closer inspection with separate evaluation items.
The data reflect a lower rate of major and minor amputations in specialist centres compared with the available epidemiological data for Germany as a whole (Trautner et al, 2001; Heller et al, 2004).
This analysis presents the first German data collected using defined standards that include amputation rate and mortality in the treatment of the diabetic foot in specialist centres.
Both the data from this analysis and the proceedures of the German Diabetes Association by which accreditation is granted should be of interest to people working in other healthcare systems. In Germany, some insurance companies require treatment centres to be accredited by the German Diabetes Association in order for medical costs accrewed by the treatment of diabetes-related foot conditions be reimbursed.
The next evaluation, scheduled for the next year or so, should provide elucidating data on the development of quality in the participating centres.
The German Working Group on the Diabetic Foot has established comprehensive quality assurance measures for diabetic footcare centres and implemented them nationally. In addition, useful data from a very large treatment cohort has been gained.