A randomised controlled clinical trial comparing the effectiveness of bandaging compared to the JuxtaCures™ device in the management of people with venous ulceration: Feasibility study.

INTRODUCTION: The mainstay of treatment for venous ulceration remains compression therapy. Velcro Wrap devices are being increasingly used in these patients despite limited evidence. This feasibility study aimed to compare standard bandaging to the JuxtaCures™ Velcro wrap device. METHODS: A single centre, unblinded RCT compared participants with venous ulceration randomised to either the JuxtaCures™ device or short stretch bandaging. Participants were followed up for 26 weeks. RESULTS: 160 participants were screened with 40 randomised. 3 participants in bandaging and 1 in JuxtaCures™ didn't complete the study. 60% in JuxtaCures™ healed v 55% in bandaging despite larger ulcers in the JuxtaCures™ arm (9.33 cm2 v 6.97 cm2). There was no significant difference in time to healing (12.17 v 13.64 weeks). JuxtaCures™ showed improved ulcer reduction for those that didn't heal (14.91-5.00 cm2 v 14.20-8.62 cm2; P = 0.06). JuxtaCures™ had more consistent sub-bandage pressure dropping from 39-36 mmHg versus 41-25 mmHg in bandaging between application and removal (P < 0.001). Quality of life (EQ5D) was improved in JuxtaCures at 3 months (mean difference 0.14, p = 0.04), but not at 1 and 6 months, or in disease specific quality of life. Cost was lower in JuxtaCures™ £842.47 v £1064.68. Duration of appointment was significantly shorter in JuxtaCures™ (41 minutes v 53 minutes; P = 0.003). CONCLUSION: This study has shown the feasibility and necessity of running a multicentre trial to evaluate the use of Velcro wrap devices for venous ulceration. It highlights the potential benefits of more consistent pressure, increased self-care, and potential with regards to ulcer healing, cost, nursing resource and quality of life.

Review of adjustable velcro wrap devices for venous ulceration.

Compression therapy is the mainstay of treatment for patients with venous leg ulcers. Current gold standard is 4 layer bandaging, which has a significant impact on patients comfort, ability to wear their own shoes, and quality of life, as well as taking significant time to apply, and losing compression over time. This systematic review aims to evaluate the use of Velcro wrap devices for the treatment of venous ulceration. Preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines were used to identify articles reporting the use of Velcro wrap devices in patients with venous ulceration. Sixteen articles were identified (14 case series, 1 randomised trial, and 1 audit) reporting on 192 patients. There were reports of improved time to healing, reduced cost by >50%, reduced number and duration of nursing appointments, and improved quality of life in patients in Velcro wrap devices. Although the evidence remains poor, Velcro devices have potential to improve outcomes for patients with venous ulceration and further good quality studies should be undertaken to evaluate these further.