Treating Venous Leg Ulcers in Primary Care: The Cluster-Randomized Ulcus Cruris Care Trial

Abstract

Background: Venous leg ulcers (VLUs) markedly restrict patients' everyday activities and impair their quality of life. Compression is the most important treatment measure but is often not consistently implemented in practice. The aim of the Ulcus Cruris Care (UCC) project was to develop a primary care approach for the systematic support of evidence-based, patient-centered treatment.

Methods: UCC consists of online training for care teams, software-supported case management, and patient training. Block randomization (1:1) was performed at the level of individual primary care practices. The practices recruited patients with UCV. Each patient was followed up for 12 months. The primary endpoint was wound healing, as confirmed by two independent blinded investigators. The secondary endpoints were guideline-compliant compression, health-related quality of life (EQ-5D-5L), depression (PHQ-9), and case-related treatment costs.

Results: 59 patients were included. For the primary endpoint of time to wound healing, the intervention yielded a hazard ratio of 2.71 [0.66; 11.06] (p = 0.16). The odds ratio for complete wound healing was 3.60 [0.97; 13.36] (p = 0.049). Guideline-compliant compression was more common in the intervention group (72% versus 33%; p = 0.010). Depression (5.3 ± 6.1 versus 10.0 ± 6.9; p = 0.019) and outpatient treatment costs (€1457 ± 917 versus €3153 ± 1843; p = 0.016) were lower in the intervention group.

Conclusion: This multicenter RCT suggests a potential benefit of the UCC intervention but does not confirm its efficacy. The UCC approach can specifically target deficits in outpatient care for chronic wounds at the primary care level.