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

Varicose Ulcer Clinical Trial

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

Clinical Trial Summary

The objective of this Bayesian Adaptive trial is to compare a control group versus a comprehensive ulcer healing protocol. The latter involves a combination of compressive therapy, miokinetic drainage and muscle strengthening for the entire lower extremity pump among patients with lower extremity venous ulcers. The investigators hypothesized that the combined therapy will have a higher closure rate as well as lower time to closure.

Clinical Trial Description

This is a Bayesian adaptive, randomized, controlled, parallel, two-armed Bayesian adaptive trial. Patients diagnosed with varicose ulcers through Doppler ultrasonography will be recruited at the Pro Circulation Clinic of Angiology and Vascular Surgery, Brazil. The active group will be the Vein Fitness system, a multimodal intervention comprising exercise, lymphatic drainage, and compressive therapy, while the control group will be standard compressive therapy and regular wound care. The researchers will measure closure of the wounds and the closure rate as the primary outcomes. The study was designed in accordance with the CONSORT statement. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03127904
Study type Interventional
Source Pró Circulação®
Contact Eduardo Matta, MD
Phone 55 (49) 3433-9050
Email procirculacao@gmail.com
Status Recruiting
Phase N/A
Start date July 24, 2018
Completion date December 30, 2025
View Details
See also
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Active, not recruiting NCT03744858 - The Role of Pyroptosis in Chronic Venous Disease
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Completed NCT04039789 - Impact of Physical Activity as a Coadjuvant Treatment in the Healing of Venous Ulcers in Primary Health Care. N/A
Completed NCT04280679 - Treatment of Insufficient Superficial and Perforatring Veins of the Lower Limb Using HIFU N/A
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Completed NCT02896725 - Wool-derived Keratin Dressings for Venous Leg Ulcers N/A
Completed NCT04310280 - Effects of Local Insulin on Varicose Ulcers for Wound Healing Phase 3
Completed NCT02626156 - Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence Phase 2
Withdrawn NCT00648674 - A Post-Marketing Clinical Study of Apligraf for Venous Leg Ulcers Phase 4
Terminated NCT00727701 - Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development Phase 1
Completed NCT00399308 - Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers Phase 1/Phase 2
Completed NCT00426972 - Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites Phase 3