Abstract
BackgroundVenous leg ulcers (VLU) have a prevalence of 1–2% in developed countries, and affected patients are severely and long-term impaired in daily activities, work, and social participation. Evidence-based outpatient treatment based on compression therapy is frequently not implemented. The “Ulcus Cruris Care” project was established to develop a disease management concept to improve outpatient treatment for patients with VLU in German primary care. For this purpose, a multifaceted intervention was conceived consisting of an online training for general practitioners and medical assistants, standardized treatment recommendations, e-learning and print-based information for patients, and a software support for case management. The main aims of the Ulcus Cruris Care intervention are to promote standardized treatment according to current scientific knowledge, to facilitate case management for VLU patients exerted by medical assistants, and to support patient education and participation in the treatment process. The UCC trial was designed to evaluate the effectiveness of the Ulcus Cruris Care intervention.MethodsThe UCC trial is a prospective cluster-randomized controlled multicenter trial. Fifty GP practices are intended to be recruited and randomized 1:1 to intervention or control arm. Patients with venous leg ulcers will be recruited by participating GP practices, to include a total of 63 patients in each arm. The primary outcome is time to ulcer healing. Secondary outcomes comprise number and sizes of ulcers, recurrence, pain intensity according to the visual analog scale, health-related quality of life according to EQ-5D-5L, depressiveness according to Patient Health Questionnaire (PHQ-9), patient satisfaction according to the Patient Assessment of Chronic Illness Care (PACIC-5A) query, and adherence to VLU treatment. The outcome analysis of the UCC trial is accompanied by a health economic analysis and a process evaluation.DiscussionThe UCC trial will evaluate whether the Ulcus Cruris Care intervention may lead to faster wound healing, higher health-related quality of life, and lower use of medical resources. If the intervention turns out to have a positive impact on assessed outcomes, comprehensive implementation in primary care may be considered.Trial registrationThe trial protocol (version 1 as of July 19, 2021) has been registered in the German Clinical Trials Register on August 30, 2021 (DRKS00026126).
Highlights
Venous leg ulcers (VLU) have a prevalence of 1–2% in developed countries, and affected patients are severely and long-term impaired in daily activities, work, and social participation
Even with the best treatment, wound healing may take several months, and affected patients are severely impaired in daily activities, work, and social participation resulting in a reduced quality of life and a high prevalence of psychological disorders [3,4,5,6]
The main aims of the Ulcus Cruris Care intervention are to promote standardized treatment of VLU according to current scientific knowledge, to facilitate case management for VLU patients exerted by medical assistants, and to support patient education and active participation in the treatment process
Summary
Fifty GP practices in the federal state of Baden-Wuerttemberg are intended to be recruited by the study center, the Department of General Practice and Health Services Research (University Hospital Heidelberg, Germany), and randomized 1:1 to intervention or control arm. Patients with VLU will be recruited by the participating GP practices, to include a total of 63 patients in the intervention arm and 63 patients in the control arm. The study hypothesis is that implementation of disease management for VLU patients in GP practices according to the “Ulcus Cruris Care” intervention can lead to faster wound healing for affected patients. The trial timeline is shown in a SPIRIT figure (Additional file 2). Ankle Brachial Index of affected lower extremity < 0.5 or ankle artery pressure < 60 mmHg
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