Comparing Vein Fitness System to Compressive Therapy for Healing Venous Ulcers

Pragmatic, Bayesian Adaptive Trial Comparing the Venfit System Against Standard Compressive Therapy in the Treatment of Venous Ulcers

This study is testing if a new treatment that combines exercise and lymphatic drainage with compression can help people with venous ulcers heal faster than just using compression alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pró Circulação® (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Xanxerê, Santa Catarina)
• Trial ID: NCT03127904 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the effectiveness of the Vein Fitness system, which combines exercise, lymphatic drainage, and compressive therapy, against standard compressive therapy for patients with varicose ulcers. It is a Bayesian adaptive, randomized, controlled trial conducted at the Pro Circulation Clinic in Brazil. The study will measure the rate of wound closure and the time taken for closure as primary outcomes. Patients diagnosed with venous ulcers will be recruited and assessed using Doppler ultrasonography.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with varicose ulcers due to chronic venous disease.

Not a fit: Patients with ulcers from other causes, such as arterial insufficiency or those who are wheelchair users, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved healing rates and faster recovery for patients with venous ulcers.

How similar studies have performed: Other studies have shown promise in using multimodal approaches for ulcer healing, but this specific combination is relatively novel.

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).

Where this trial is running

Xanxerê, Santa Catarina

• Pró-Circulação - Clinic of Angiology and Vascular Surgery — Xanxerê, Santa Catarina, Brazil (Recruiting)

Study contacts

• Principal investigator: Eduardo Matta, MD — Pró Circulação®
• Study coordinator: Eduardo Matta, MD

Conditions Varicose Ulcer; Varicose ulcer; Compressive therapy; Venous ulcer; Chronic venous disease