Vein Fitness System vs Compressive Therapy for Venous Ulcers: a Bayesian Adaptive Trial

Launched by PRÓ CIRCULAÇÃO® · Apr 20, 2017

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with venous ulcers, which are sores that can occur on the legs due to poor blood flow. The study is comparing a standard treatment, known as compressive therapy, with a comprehensive healing program that combines compressive therapy, muscle exercises, and drainage techniques to improve blood circulation in the lower legs. The researchers believe that this combined therapy may help more ulcers heal faster than the standard approach.

To participate in this trial, individuals should be between the ages of 65 and 74 and have venous ulcers confirmed by a specific ultrasound test. However, those with ulcers caused by other conditions, such as poor blood supply, or who cannot perform the exercises due to being in a wheelchair, will not be eligible. Participants can expect to receive a detailed treatment plan and may be asked to attend regular appointments to monitor their progress. Overall, this trial aims to find a more effective way to help people heal from venous ulcers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Venous ulcers due to chronic venous disease assessed by color duplex scan (CDS) examination in standing position. Reflux will be assessed using CDS over a longitudinal vein through the manual compression of the calf in a distant position from the examined area. Reflux will be considered pathological if: \>0.5 seconds (s) in the superficial venous system, or \> 1.0 s in the deep system, or \> 0.35 s in a perforator vein.
• Exclusion Criteria:
• • Investigators will exclude patients with ulcers from any other cause, including arterial insufficiency, with ankle-brachial pressure index (ABPI) \< 0.8. Also will be excluded patients who use immunosuppressive and chemotherapy drugs, who have allergies to compression materials, and wheelchair users (due to the impossibility of performing the exercises).