Utilizing the adjustable Velcro system Compreflex® for patients with chronic venous leg ulcers: An observational multicenter clinical follow-up study

Abstract

Introduction

Venous leg ulcers (VLUs) pose significant challenges that adversely affect patients’ quality of life and result in considerable economic burdens. While existing compression therapies are effective, they are often hindered by complexity, discomfort, and environmental concerns.

Objectives

This study aimed to evaluate the performance and safety of the adjustable Velcro system Compreflex®, an alternative to traditional four-layer bandaging, for patients with chronic venous leg ulcers. The evaluation was conducted through a clinical follow-up trial.

Methods

This prospective, non-randomized, multicenter, single-arm study included 98 patients with VLUs. The Compreflex® Standard Calf and Foot device was assessed based on wound closure rates, patient satisfaction, and edema reduction. Patients were followed up at specific intervals: after 1, 12, and 26 weeks.

Results

Of the 98 enrolled patients, 19 discontinued participation. The mean ulcer area decreased from 52.9 cm² (95% CI, 35.9–69.9 cm²) to 37.4 cm² (95% CI, 20.0–54.7 cm²) at 26 weeks (p < .001). The wound closure rate at 26 weeks was 24.3% (95% CI, 16.6–34.9%). Challenges related to self-application were minimal, highlighting the device’s usability. A patient satisfaction rate of 76.8% was reported, based on a satisfaction score of six or higher.

Conclusion

This study provides valuable real-world evidence supporting the effectiveness and usability of the Compreflex® device, as demonstrated by the high patient satisfaction rate, and highlights its potential as a promising alternative in compression therapy for venous leg ulcers.