Treatment pathways for patients with chronic wounds in Germany

Original article 1 Treatment pathways for patients with chronic wounds in Germany Results of a prospective study in 100 patients with chronic leg ulcers M. Stoffels-Weindorf 1 ; H. von der Stück 1 ; J. Klode 2 ; J. Dissemond 2 1 Department of Dermatology, Venereology and Allergology, Essen University Hospitals; 2 Department and OPD for Dermatology Venereology and Allergology, Essen University Hospitals, Essen, Germany Keywords Chronic wounds, leg ulcers, treatment pathways, interdisciplinary wound care, wound centers Summary Introduction: Chronic leg ulcers present a challenge to both patients and those treating them. Various specialists with particular areas of interest will be involved in the treatment of patients with chronic wounds at different times. Hardly any studies on the treatment pathways for patients with chronic leg ulcers in Germany are to be found in the current literature. Patients and Methods: We ascertained the treatment pathways of 100 patients who presented to our wound centre because of chronic leg ulcers. Data were collected prospectively by taking a history using a specially developed questionnaire and review of any available documentation. Results: On average, patients with chronic leg ulcers presented to our wound centre 17. months after the first appearance of the lesion. Patients with recurrent ulcers came significantly earlier (10.6 months) than patients with a primary lesion (22.6 months); patients with inflammatory disease presented after an average of 9.1 months. Patients with severe pain came after 16. months, while patients with less painful ulcers took 19. months. Overall, 7 % of the patients consulted their Correspondence to Prof. Dr. med. Joachim Dissemond Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Hufelandstraße, 122 Essen, Germany Tel. +9-201/72 89, Fax 9 E-Mail: joachim.dissemond@uk-essen.de general practitioners in the first instance, 28 % a dermatologist, 10 % a general surgeon, % an internal specialist and 2 % a vascular surgeon, while 10 % presented directly to our outpatient clinic. Discussion: Our data show that patients with chronic leg ulcers do not attend a tertiary care wound centre until, on average, they have undergone 1. years of usually unsuccessful treatment. Factors indicating an early presentation are an inflammatory aetiology, individual prior experience, and severe pain. To prevent wounds becoming chronic and to reduce the risk of refractory lesions, patients with delayed or impaired wound healing should be referred to a specialist or a dedicated wound centre within eight weeks at most. Schlüsselwörter Chronische Wunde, Ulcus cruris, Versorgungswege, interdisziplinäre Wundversorgung, Wundzentren Zusammenfassung Einleitung: In die Behandlungsabläufe von Patienten mit chronischen Wunden sind zu unterschiedlichen Zeitpunkten verschiedene Berufsund Facharztgruppen involviert. Zu den Versorgungswegen der Patienten mit einem chronischen Ulcus cruris in Deutschland finden sich in der aktuellen Literatur kaum Untersuchungen. Versorgungswege von Patienten mit chronischen Wunden in Deutschland Resultate einer prospektiven Studie bei 100 Patienten mit chronischem Ulcus cruris Phlebologie 201; 2: 18 188 DOI: 10.12687/phleb211--201 Received: April 22, 201 Accepted: May 1, 201 Patienten und Methoden: Prospektiv sollten die Behandlungswege von 100 Patienten, die aufgrund eines chronischen Ulcus cruris in unserem Wundzentrum vorstellig wurden erhoben werden. Die Datenerhebung erfolgte anamnestisch mit Hilfe eines neu entwickelten Fragebogens und falls vorhanden nach Durchsicht von Unterlagen. Ergebnisse: Patienten mit chronischem Ulcus cruris stellen sich durchschnittlich nach 17, Monaten nach Erstmanifestation in unserem Wundzentrum vor. Patienten mit Rezidiv kommen nach durchschnittlich 10,6 Monaten Behandlungszeitraum signifikant früher als Patienten mit Erstmanifestation (22,6 Monaten); Patienten mit entzündlichen Erkrankungen werden nach durchschnittlich 9,1 Monaten angebunden. Patienten mit stärkeren Schmerzen kommen nach 16, Monaten in unserem Wundzentrum, Patienten mit weniger starken Schmerzen nach 19, Monaten. Insgesamt 7 % der Patienten suchen als ersten Arztkontakt ihren Hausarzt, 28 % einen Dermatologen, 10 % einen Chirurgen, % einen Internisten und 2 % einen Gefäßchirurgen auf. Insgesamt 10 % der Patienten stellen sich ohne vorherigen Arztkontakt direkt in unserer Ambulanz vor. Diskussion: Unsere Daten zeigen, dass Patienten mit chronischem Ulcus cruris erst nach einem Zeitraum von durchschnittlich 1, Jahren, meist frustraner Therapie in einem Wundzentrum der Maximalversorgung vorstellig werden. Die wesentlichen Faktoren für eine frühzeitigere Vorstellung sind die entzündliche Genese, individuelle Vorerfahrungen sowie stärkere Schmerzen. Um Chronifizierungen zu vermeiden und die Gefahr therapierefraktärer Verläufe zu vermindern, wäre eine frühzeitigere Vorstellung von Patienten mit stagnierender Wundheilung nach spätestens 8 Wochen bei einem Spezialisten bzw. in einem Wundzentrum wünschenswert. Schattauer 201 Phlebologie /201

2 M. Stoffels-Weindorf et al.: Treatment pathways for patients with chronic wounds in Germany It is estimated that in Germany today, some 2 million patients have chronic wounds of various aetiologies (1). Besides leg ulcers, these chronic wounds include pressure sores (decubitus ulcers), arterial ulcers and diabetic foot syndrome. The prevalence of chronic wounds increases with age (2). Current demographic trends mean that the care of patients with chronic leg ulcers will in future have a greater impact on routine clinical practice in a wide range of medical specialties (1). In accordance with current guidelines, a wound is considered to be chronic if it has not healed within eight weeks, despite appropriate treatment (). Studies have shown, however, that patients may suffer from refractory leg ulcers for years or even decades. Every day, the care of patients with chronic leg ulcers presents a huge challenge to patients and healthcare workers alike. Studies show that patients with chronic leg ulcers have a greatly reduced quality of life () and also that costs incurred in the management of these patients generate a huge burden for the healthcare system (). Direct costs include the costs of materials, personnel needed for regular time-consuming dressings, medication usually required for pain, and diagnostic investigations; in addition, there are associated indirect costs such as loss of working days, early retirement and high insurance costs. An accurate diagnosis is essential for the causal treatment of patients with chronic leg ulcers. Comprehensive targeted diagnostic investigation usually requires interdisciplinary cooperation. In tertiary care wound centres, interdisciplinary and interprofessional management is the norm. One possibility to standardise the procedures in the investigation and treatment of wounds in a transparent manner is accreditation, usually certification by the ICW e.v. (certifying body for wound management), sometimes with additional criteria defined by the German Association of Vascular Surgeons (DGG) or Dermatologists (DDG) (). Medical management structures in Germany follow the lines that patients begin self-treatment when the wound appears. If the lesion does not heal within a few days or weeks, patients should consult their general practitioners (GPs). If the wound appears very complex or it does not heal completely, the patient should be referred to a specialist. In the current literature, however, there are no analyses of treatment pathways for patients with chronic leg ulcers in Germany. The aim of our study was therefore to carry out a prospective single-centre clinical study on the treatment pathways for patients with chronic leg ulcers, from the appearance of the lesion to the time they first presented to our wound centre, in order to determine and compare the different pathways. Patients and methods Patients The prospective, single-centre study analysed data from 100 patients. We collected data from July 2012 to January 201. All patients with a leg ulcer persisting for at least eight weeks were included consecutively. Patients with other chronic wounds, such as diabetic foot syndrome or pressure ulcers, were excluded. Data collection To obtain the data, we took a history from the patient using a specially developed questionnaire and reviewed all available documentation, some of which was requested from the doctor previously treating the patient. The questionnaire asked when the lesion first appeared, the patient s age at that time, and the site of the wound. A distinction was made between primary leg ulcers and recurrences. In addition, the questionnaire contained items covering the duration of self-treatment after the appearance of the lesion until the patient went to a doctor, the specialty of the doctor first consulted, and the length of time before consulting another doctor. It also recorded the number of times the patient had changed doctors, and the length of time between first seeing a doctor and coming to our wound centre. Pain was assessed objectively using a visual analogue scale (VAS), ranging from 0 to 10. We measured the size of the ulcer by planimetry using Visitrak (Smith&Nephew, Hamburg). Diagnostic investigations If they did not bring reports of recent investigations carried out elsewhere, all patients had duplex ultrasound scans to investigate chronic venous insufficiency (CVI). We checked that peripheral pulses were palpable and measured the ankle brachial index (ABI) to screen for peripheral arterial occlusive disease (paod). If the results were abnormal or paod suspected, we referred the patient to the local angiology department for more detailed investigation. Depending on the provisional clinical diagnosis, biopsies were taken and specific serological tests performed as indicated. Statistics We used the Statistical Packet for Social Sciences (SPSS) Version 20 (SPSS Inc., Chicago) for the statistical analysis. Means and medians were compared by means of the non-parametric Mann-Whitney U test. The level of significance was set at p<0.0. Results Patient population During the course of the study, we collected data from 100 patients: 6 men and women. The mean age at first presentation was 6. years. Leg ulcers were primary lesions in 7 patients and recurrences in. Ulceration occurred on the left lower leg in 7 % of cases and on the right lower leg in 6 %; lesions were bilateral in 7 %. The mean size of the ulcers was 12.7 cm 2, ranging from 0.2 cm 2 to 111. cm 2. Aetiology of the ulcers Seventy patients had venous leg ulcers, four patients had arterial leg ulcers and six patients had ulcers of mixed origin. There were three cases of leucocytoclastic vasculitis and five patients had pyoderma gangrenosum. Twelve patients had ulcers of other aetiology, for example, livedo vasculopathy, necrobiosis lipoidica, and drug-induced ulceration from treatment with hydroxyurea. Phlebologie /201 Schattauer 201

M. Stoffels-Weindorf et al.: Treatment pathways for patients with chronic wounds in Germany Cofactors Pain measured on the VAS by patients presenting to our wound centre for the first time showed a mean of.9 on a scale of 0 10 (minimum 0/0; maximum 10/10). Patients included in the study included 26 with type 2 diabetes. One patient had type 1 diabetes ( Tab. 1). Self-treatment The mean duration of self-treatment from the appearance of the wound to the first time the patient consulted a doctor was 0.7 months. The range was days to 12 months. Initial contact with a doctor The GP was the first doctor to be consulted about leg ulcers by 7 patients; 28 patients consulted a dermatologist, 10 patients went to see a general surgeon, three patients saw an internal specialist and two patients presented to a vascular surgeon. Ten patients came directly to our wound centre without having consulted a doctor at all. The mean length of treatment from the first doctor consulted was 9.7 months; the longest period was 16 years. Subsequent medical consultations After patients changed doctor, 2 of them went to a dermatologist and 22 saw a general surgeon. Four patients consulted an internal specialist and another four went to see a vascular surgeon. Of the patients we examined, 6 had not already had a second opinion but had been referred directly by the first doctor. Our study found no statistically significant correlation of specific entities with a particular specialist group. Our results showed that 1 % of patients had visited two doctors before attending the tertiary care wound centre. Considering patients with venous leg ulcers,. % (n=76) had previously consulted one doctor and 8.8 % (n=76) had been treated by two doctors before presenting to our wound centre. More of the patients with less common causes, some Tab. 1 Patient characteristics. VAS visual analogue scale. Parameter Age (years) Sex male female Ulcer size (cm2) Aetiology venous leg ulcers arterial leg ulcers leg ulcers of mixed origin vasculitis pyoderma gangrenosum other Site left lower leg right lower leg both lower legs Recurrence Pain < (VAS) Pain > (VAS) 7.8 % (n=2), had been seen by a second doctor. Out of all patients, 9 % had seen three doctors, while one patient in each case had been treated by four, five, or six doctors, and one had been seen by as many as 18 different doctors ( Tab. 2). Fig. 1 Time to presentation at a wound centre in relation to the aetiology of the ulcer. Results 6. ± 1.1 6 12.7 ± 20.2 70 6 12 6 8 6 2 68 Time to first presentation at the wound centr (in month) 2 20 1 10 0 All Tab. 2 Overview of medical specialties involved in primary and secondary consultations. Results Primary consultation general practitioner dermatologist general surgeon specialist in general medicine vascular surgeon wound centre Secondary consultation dermatologist general surgeon specialist in general medicine vascular surgeon wound centre Recommended to go to wound clinic by doctor relative/friend self-referral Venous leg ulcers Vasculitis Frequency (absolute) 7 28 10 2 10 2 22 6 80 1 19 Length of time before coming to our wound centre The time taken for patients with chronic leg ulcers to present to the tertiary care wound centre after they first saw a doctor ranged from three days to 216 months, giv- Cause of chronic leg ulcers Others Schattauer 201 Phlebologie /201

M. Stoffels-Weindorf et al.: Treatment pathways for patients with chronic wounds in Germany ing a mean of 17. months. Looking at the different groups, patients with chronic venous leg ulcers presented after 1.8 months, in contrast to patients who had ulcers of rare origin, such as pyoderma gangrenosum, necrobiosis lipoidica or drug-induced ulceration, who were first seen in our centre after a mean of 20.7 months. Patients with leucocytoclastic vasculitis came after only 1.8 months. Of the under-60s in our study, 7.8 % (n=7) had seen only one doctor before coming to our clinic ( Fig. 1). Discussion Current situation There are many causes of chronic leg ulcers (6). An accurate diagnosis is essential for appropriate treatment. In routine clinical practice, a wide range of therapeutic options is available for the management of patients with chronic wounds. The often interventional causal treatment includes an ever-increasing number of different wound therapies. Causal treatment cannot be initiated, however, without comprehensive diagnostic investigation and determination of the underlying cause. Targeted interdisciplinary cooperation helps in making a more rapid and accurate diagnosis. Many patients with chronic leg ulcers have a protracted medical history, having seen several doctors over time. Even so, the current literature contains hardly any information on the treatment pathways of patients with chronic leg ulcers in Germany. Our data show that patients usually seek medical help promptly after a relatively short period of self-treatment lasting about three weeks. According to the guidelines of the Deutsche Gesellschaft für Wundheilung und Wundbehandlung e.v (German society for wound healing and treatment), patients do not, by definition, have chronic wounds at this stage (). Tab. Characteristics of patients according to the presence of recurrent ulcers. WO Wound Outpatients. Age (years) Sex male female Ulcer size (cm2) Aetiology venous leg ulcers arterial leg ulcers leg ulcers of mixed origin vasculitis pyoderma gangrenosum other Length of treatment (months) self-treatment first contact with doctor until first attended WO Total (n=100) 6. ± 1.1 6 12.7 ± 20.2 70 6 12 0.7 9.7 17. No recurrence (n=7) 6.7 ± 16.6 27 (7.%) 0 (2.6%) 1. ± 21.1 (9.6%) 2 (.%) (8.8%) (.%) (8.8%) 8 (1.0%) 0.6 9.9 22.6 With recurrence (n=) 66.2 ± 1.1 19 (.2%) 2 (.8%) 10. ± 19.1 6 (8.7%) 2 (.7%) 1 (2.%) 0 0 (9.%) 0.8 9. 10.6 Difference (p) 0.68 0.1 0.01 0.89 0. <0.001 The wounds usually only become chronic when the patients are already under medical care. Doctors consulted by patients with chronic leg ulcers The first doctor seen by 7 % of patients is the GP. For our patients, the average length of GP treatment was 9.7 months. However, only 0.2 % of the patients in our study who had recurrent chronic ulcers went to see their GPs for treatment. Our data show that patients with recurrent ulcers more often (7.2 %) consult a dermatologist directly for further treatment. It can be debated whether these patients already know particular specialists on the basis of their earlier experience and therefore seek them out more quickly. This would also explain why.9 % of the patients with recurrent leg ulcers saw only one doctor before coming to our clinic; 1.0 % of patients with primary lesions saw at least two doctors previously. The time from first seeing a doctor to presenting at our wound centre is considerably shorter for patients with recurrent ulcers (mean 10.6 months) than for those with primary lesions (mean 17. months). In 7.2 % (n=) of patients with recurrent ulcers, attendance at our clinic was on the patient s own initiative. In all the other groups, it was usually the doctor who recommended the patient to come to the wound centre. Length of time before presenting to our wound centre Our study did not confirm the hypothesis that younger patients ( 60 years) consult doctors more frequently because of their greater mobility. Overall, 7.8 % of the under-60s (n=7) had seen only one doctor before coming to our wound centre the GP in.1 %. The average length of time before coming to our wound centre was 28. months in this group. In contrast, in the over-60s (n=6) the interval until the first attendance was only 10.9 months. One possible explanation for this clear difference might be that 28 patients in the older group had recurrent ulcers and therefore already had experience of the condition. Phlebologie /201 Schattauer 201

M. Stoffels-Weindorf et al.: Treatment pathways for patients with chronic wounds in Germany Even so, in 81 % of the over-60s, it was the doctor who referred the patient to the wound centre. Living a greater distance from the wound centre might be the reason for these patients, often with multimorbidity, not to travel to a tertiary care centre on their own initiative. Furthermore, our results show differences between patients with severe pain (VAS /10 points) and those with mild to moderate pain. On average, patients with mild to moderate pain (n=2) came to our clinic 19. months after first seeing a doctor, while patients with severe pain (n=68) came after a considerably shorter interval of 16. months. The reason for this difference may be that patients with severe pain suffer more from the condition, causing them to present to a wound centre more quickly. In both groups, most patients are recommended to go to the wound centre by their doctors: 78.1 % of patients with pain scores of less than on the VAS, and 80.9 % of patients with pain scores. With respect to ulcer size as a possible factor reducing the length of time before attendance at our clinic, we found that patients with wounds <cm 2 had already had medical treatment for 1.2 months on average before presenting to our wound centre. Patients with ulcers cm 2 were treated for considerably longer (19. months on average) ( Tab. ). Effects of the aetiology on the treatment pathways There are many different causes of leg ulcers. Data we have collected in recent years on the aetiology of leg ulcers show that there are sometimes considerable differences, depending on the treating specialty, the patient clientele and the cause of the ulceration. In our dermatology wound centre in Essen, for example, venous ulcers are the most common, accounting for 7.2 % of chronic wounds, followed by 1.7 % due to ulcers of mixed origin. Vasculitis (1. %) ranks in third place as the cause of ulceration, although practicebased doctors make this diagnosis in only 2.2 % of cases (7 10). As for the aetiology being a significant factor influencing the treatment pathways of patients with leg ulcers, our study has also shown large differences. On average, patients with chronic venous leg ulcers presented to our wound centre after 1.8 months. Patients with rapidly progressive or severely painful ulcers, such as those of leucocytoclastic vasculitis, attended after only 1.8 months. Patients with rare causes of leg ulcers, such as necrobiosis lipoidica, pyoderma gangrenosum or drug-induced lesions did not come to our clinic until 20.7 months had elapsed. It can be debated whether the reason for this late presentation might be prolonged investigation or misdiagnosis of a rare cause of ulceration that has led to protracted and often inappropriate treatment by the doctor(s) seen previously. Our data do not, however, show a clear-cut distinction in the number of doctors previously consulted by patients with leg ulcers of inflammatory origin. With an interval of up to a maximum of 216 months before attending our wound centre, our data show that treatment pathways for patients with chronic leg ulcers are sometimes very protracted. On average, patients did not present to us until after some 1. years of usually unsuccessful treatment. The protracted chronic course of the wounds greatly impacts the patients quality of life (11). And long-term care also Conclusions Prompt attendance at a wound centre or consulting a specialist in wound management is definitely worthwhile for the diagnostic investigation and initiation of causal treatment for patients with chronic leg ulcers, in order to reduce the risk of unnecessarily protracted treatment. It is always worth involving a wound centre whenever an ulcer is not showing clear signs of improvement within eight weeks of apparently adequate treatment. Patients with clinically atypical wounds, as well as those with particularly pronounced or complicated findings, should be referred without delay. incurs huge costs (12, 1). A research group in Hamburg recently carried a study on disease-related costs in patients with chronic leg ulcers. Data were collected from 2 wound centres in Germany. Purwins et al. distinguished between direct and indirect costs in these patients. Direct costs included costs for treatment, nursing care services, dressing materials and diagnostic investigations. Loss of working days and early retirement were counted in the indirect costs. According to the study results, total costs for patients with chronic leg ulcers are 9 69 Euro per year. Limitations of the study Our data were collected in a dermatology tertiary care wound centre. They cannot therefore be extrapolated to give a complete picture of the outpatient care of patients with chronic leg ulcers in Germany. Patients at our wound centre often have lesions for which treatment has so far been unsuccessful hard-to-heal wounds or leg ulcers due to rare causes. The distance between referral institutes may have an effect on the treatment pathway. Results from the densely populated Ruhr area may well be different from other regions in Germany, where, for example, the patient has to travel a much greater distance to reach a dedicated wound centre. Conflict of interest The authors confirm that there are no conflicts of interest. References 1. Dissemond J. Ulcus cruris Genes, Diagnotik und Therapie.. Auflage, Bremen: UNI-MED; 2012. 2. Rabe E, Pannier-Fischer F, Bromen K, Schuldt K, Stang A, Pancar C, et al. Bonner Venenstudie der Deutschen Gesellschaft für Phlebologie. Phlebologie 200; 2: 1 1.. Deutsche Gesellschaft für Wundheilung und Wundbehandlung ev. Lokaltherapie chronischer Wunden bei Patienten mit den Risiken periphere arterielle Verschlusskrankheit, Diabetes mellitus, chronische venöse Insuffizienz. AWMF-Register Nr 091/001.. Purwins S, Herberger K, Debus ES, Rustenbach SJ, Pelzer P, Rabe E, et al. Cost-of-illness of chronic leg ulcers in Germany. Int Wound J 2010; 7(2): 97 102. Schattauer 201 Phlebologie /201

6 M. Stoffels-Weindorf et al.: Treatment pathways for patients with chronic wounds in Germany. Diener H, Storck M, Dissemond J, Karl T, Riepe G, Eder S, et al. Wundzentren. Gefässchirurgie 2012; 17: 0. 6. Dissemond J, Körber A, Grabbe S. [Differential diagnoses in leg ulcers]. J Dtsch Dermatol Ges 2006; (8): 627 6. 7. Klode J, Wax C, Körber A, Dissemond J. Genese und Behandlungswege der Patienten mit einem chronischen Ulcus cruris Auswertung einer Befragung von 1000 niedergelassenen Fachärzten und Allgemeinmedizinern. Phlebologie 2009; 8: 211 218. 8. Körber A, Dissemond J. Genese des chronischen Ulcus cruris: Auswertung einer Befragung der DGfW. ZfW 2008; 1: 226 21. 9. Körber A, Klode J, Al-Benna S, Wax C, Schadendorf D, Steinstraesser L, et al. Etiology of chronic leg ulcers in 1,619 patients in Germany analyzed by an expert survey. J Dtsch Dermatol Ges 2011; 9(2): 116 121. 10. Körber A, Schadendorf D, Dissemond J. [Causes of leg ulcers. Analysis of the data from a dermatologic wound care center]. Hautarzt 2009; 60(6): 8 88. 11. Hartmann M, Schulz D, Gundermann C, Norgauer J. [Economic aspects of standardization of modern wound care]. Hautarzt 2007; 8(11): 970 97. 12. Augustin M, Brocatti LK, Rustenbach SJ, Schafer I, Herberger K. Cost-of-illness of leg ulcers in the community. Int Wound J in press. 1. Franzke N, Augustin M. [Health services research in dermatology. Current status]. Hautarzt 2011; 62(): 170 177. 1. Dissemond J. Differenzialdiagnosen des Ulcus cruris venosum. Phlebologie 2011; 0: 8 92. The translation of this article was made possible by courtesy of: Covidien Germany GmbH Bauerfeind AG Medi Germany Sigvaris Germany Bayer GmbH Ofa Bamberg Biolitec AG Phlebologie /201 Schattauer 201