Concurrent optical and magnetic stimulation therapy in patients with lower extremity hard-to-heal wounds.

OBJECTIVE: The treatment of patients with hard-to-heal wounds represents a major multidisciplinary challenge. Therefore, the development and clinical validation of new technologies remains extremely important. The novel application of concurrent optical and magnetic stimulation (COMS) offers a promising noninvasive approach to support physiological wound healing processes, especially in hard-to-heal wounds. METHOD: In a multicentre, prospective, comparative, clinical trial, patients with hard-to-heal wounds on lower extremities of different aetiologies were treated with COMS as an adjunct to standard of care (SOC). The primary endpoint was safety; secondary endpoints were wound healing, pain and wound-specific quality of life (Wound-QoL). RESULTS: A total of 40 patients were enrolled in this study (intention to treat population (ITTP), n=40). Of these patients, 37 were included in the analysis of the primary endpoint (primary endpoint population, (PEP), n=37). A further subgroup of 30 patients was included in the analysis of the secondary endpoint (secondary endpoint population (SEP), n=30). Finally, the SEP was stratified regarding patients' responsiveness to SOC in an SOC non-responder subgroup (NRSG), n=21, and in an SOC responder subgroup (RSG), n=9. A total of 102 adverse events (AEs) were recorded, of which 96% were 'mild' or 'moderate', and 91% were either a singular or transient event. Only 11 AEs were serious and associated with inpatient treatments unrelated to the studied intervention. In the NRSG, reductions in wound size were found to be statistically significant within the different study periods. Additionally, an acceleration of the healing rate was detected between the baseline and the first four weeks of COMS treatment (p=0.041). The rate of near-complete and complete wound closure in the SEP after 12 weeks were 60% and 43%, respectively. Pain reduction across the treatment group was statistically significant (p≤0.002 for both the SEP and NRSG). The Wound-QoL score improved by 24% during the study (p=0.001). CONCLUSION: In this study, COMS treatment for patients with hard-to-heal wounds on lower extremities was a safe and effective novel treatment option, especially for patients who did not respond to SOC.

Impact of ovarian vein embolization in recurrent varicose veins of the lower extremity.

Background: The treatment success of catheter-based ovarian vein embolization due to peripheral varicose veins and ovarian vein reflux (OVR) should be investigated in this clinical investagtion. Patients and methods: For this study, 95 female patients were identified over a 5-year period (beginning of 2006 to end of 2011) after catheter-based coil (+/- chemical) embolization of the ovarian vein due to peripheral primary or recurrent varicose veins and proven reflux in the ovarian vein. Treatment success was retrospectively assessed in 2014 by means of a structured telephone interview (n=60), clinical examination (n=56), duplex ultrasound (n=56) and magnetic resonance imaging (n=51) in patients who were willing to participate in the study. Results: After an average of 51.9 months, 95.2% of the 60 included patients were diagnosed with recurrent varicose veins by duplex sonography and 88.1% by clinical examination. In 15.2%, a new intervention was required due to clinical symptoms. The median recurrence-free time was 47.0±5.5 months. A significant improvement by therapy was reported for all subjective symptoms in both pelvis and legs. No significant correlation between radiological findings and complaints or between radiological findings and clinical recurrence was found. Conclusions: The medical history of female patients with peripheral varicose veins should obligatorily include the question of symptoms in the pelvis. An appropriate diagnostic should follow in order to prevent a possible overlook of a pelvic leak point. Only then an individually adapted therapy for symptom relief is possible. Catheter-based ovarian vein embolization is one optional safe procedure that leads to significant improvement of subjective symptoms but does not necessarily prevent recurrent varicose veins.

Comorbidity and Therapeutic Approaches in Patients with Necrobiosis Lipoidica.

BACKGROUND: Necrobiosis lipoidica (NL) is a rare granulomatous disorder of unknown aetiology. Randomized controlled studies are not available due to it being an orphan disease. OBJECTIVES: We evaluated patients in 2 dermatological centres to cluster data about epidemiology, the therapeutic approaches for NL, and their efficacy. MATERIALS AND METHODS: Comorbidity and the efficacy of the applied treatment was assessed for 98 patients. RESULTS: We identified 54% of patients with concomitant diabetes and 19% with thyroidal disorders. Topical steroids (85.7%) were predominantly used followed by calcineurin inhibitors (31%) and phototherapy (41.8%). Systemically, fumaric acid esters were more frequently applied (26.8%) than steroids (24.4%) and dapsone (24.4%). Steroids, compression therapy, calcineurin inhibitors, phototherapy, fumaric acid esters, and dapsone showed remarkable efficacy. CONCLUSION: Therapeutic options were chosen individually in accordance with the severity of NL and presence of ulceration. Topical calcineurin inhibitors, systemic application of fumaric acid esters, and dapsone represent effective alternatives to the use of steroids.

Effects of Patients' Expectation in Dermatology: Evidence from Experimental and Clinical Placebo Studies and Implications for Dermatologic Practice and Research.

Patients' expectations towards the benefit of a treatment are key determinants of placebo responses and can affect the development and course of medical conditions and the efficacy and tolerability of active medical treatment. The mechanisms mediating these placebo and nocebo effects have been best described in the field of experimental pain and placebo analgesia. However, also in dermatology experimental and clinical studies demonstrate that various skin diseases such as inflammatory dermatoses and allergic reactions can be modulated by patients' expectations. Dermatologists should consider the important modulatory role of patients' expectations on the efficacy and tolerability of specific treatments and the key role of verbal information, patients' prior treatment experiences (associative learning), and the quality and quantity of doctor-patient communication in shaping treatment expectation. As a consequence, techniques aiming at maximizing patients' expectation effects should be implemented into daily clinical routine. By contrast, in clinical studies expectation effects should be maximally controlled and harmonized to improve the "assay sensitivity" to detect new compounds. Further translational studies, also in dermatoses that have not been investigated yet, are needed to better characterize the mechanisms underlying patients' expectation and to gain further insights into potential clinical implications of these effects in dermatologic conditions. Therefore, in this review, we provide a brief overview on the concept of expectation effects on treatment outcome in general, summarize what is already known about this topic for dermatologic diseases, and finally present the relevance of this topic in clinical dermatology.

Association of wound genesis on varying aspects of health-related quality of life in patients with different types of chronic wounds: Results of a cross-sectional multicentre study.

Patients with chronic wounds are significantly impaired in their health-related quality of life (HRQoL). The validated Wound-QoL questionnaire allows assessing the impact of chronic wounds on different aspects of HRQoL including physical, psychological, and everyday life-related impairments. The aim of our study was to investigate associations of these HRQoL dimensions with age, sex, and particularly wound genesis. In this retrospective, cross-sectional, multicentre study, Wound-QoL questionnaires from clinical routine of patients with venous leg ulcers, arterial leg ulcers, mixed leg ulcers, and diabetic foot ulcers (DFU) were evaluated. Effects of wound genesis, sex, and age were assessed with analysis of variance as well as correlation and multiple linear regression analyses. The completed questionnaires of 381 patients (f = 152/m = 229; mean age 68.9) were included. The wound genesis groups showed significantly different distributions of age and sex. We also found significant differences between those groups in everyday life-related QoL, with the greatest impairments in patients with DFU. Physical QoL scores showed significant differences between men and women depending on diagnosis group: in patients with venous leg ulcers, women had greater impairment of physical QoL than men. Independent of the underlying diagnosis, women had significantly higher scores in the psychological subscale as well as in the Wound-QoL sum scale. Within the subgroup of arterial leg ulcer patients, overall HRQoL sum score was significantly worse in older patients. Regression analyses supported negative effects of DFU diagnosis and female sex on HRQoL. Our data offer evidence that HRQoL shows clinically relevant differences between patients with chronic wounds of different genesis. Moreover, our data revealed that HRQoL is associated with age and sex, which should be considered when treating the patient groups. In order to be able to capture these important aspects and to offer individualised and patient-oriented treatments, the Wound-QoL should be implemented as a quick and uncomplicated standard instrument in daily routine. Patients with chronic wounds are significantly impaired in their health-related quality of life. Validated Wound-QoL questionnaire is a quick and easy-to-use instrument for daily practice. Wound-related quality of life shows clinically relevant differences between patients with chronic wounds of different genesis. Wound-related quality of life is associated with age and sex, which should be considered when treating these patient groups. Health-related quality of life should be regularly objectified in all patients with chronic wounds with a validated measuring instrument.