Compreflex® promotes ulcer healing

Results from an observational multicenter clinical follow-up study

Study aim & design

This study aimed to evaluate the performance and safety of the adjustable Velcro system Compreflex® Standard Calf and Foot in patients with chronic venous leg ulcers.

The device was assessed based on wound closure rates, patient satisfaction, and edema reduction. 98 patients were investigated at baseline and followed up at 1, 12, and 26 weeks at four hospitals in Malaysia.

The Compreflex® Standard Calf and Foot (SIGVARIS INC,USA) was used. This inelastic product consists of a calf and foot component. Accutabs enable compression ranges between 21-46 mmHg in the calf area. The foot element provides compression of up to 40 mmHg. Basic Liners undergarments are used underneath the products

Results

The device achieved a patient satisfaction rate of 76.8% based on a satisfaction score of six or higher.
The edema volume was reduced significantly, reaching a reduction of 266 ml at 26 weeks of therapy.
The mean ulcer area decreased significantly from 52.9 cm² (baseline) to 37.4 cm² (week 26), the wound closure rate at 26 weeks was 24.3%.
Challenges related to self-application were minimal, highlighting the device's usability.

Conclusion

This study shows the effectiveness and usability of the Compreflex® device, as demonstrated by the high patient satisfaction rate associated with a significant reduction of wound size, as well as lower limb edema volume, underscoring its clinical utility in promoting ulcer healing and enhancing patient experience.

What the paper adds

The study highlights the positive outcomes associated with the use of Compreflex® Standard Calf and Foot in VLU management in a real-world setting.

Reference

Nair, Harikrishna K. Ragavan, Ahmad Faidzal Bin Othman, Ahmad Rafizi Hariz bin Ramli, Muhammad Azim Bin Md Idris, Nabil Mohammad Azmi, and Muhammad Abd Jaafar. 2025. «Utilizing the Adjustable Velcro System Compreflex® for Patients with Chronic Venous Leg Ulcers: An Observational Multicenter Clinical Follow-up Study.» Phlebology 02683555251357361. doi: 10.1177/02683555251357361.