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

NCT03127904 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-09-28

No results posted yet for this study

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.

Conditions

  • Varicose Ulcer

Interventions

PROCEDURE

Vein Fitness

Vein fitness is a combination of whole-limb exercises, manual lymphatic drainage, and usual care (wound care and compressive therapy).

PROCEDURE

Compressive therapy and wound care

Compressive therapy consists in the application of pressure to the inferior limb. Investigators describe the specifics in the arm section. As previously described, a trained nurse will be in charge of keeping the wound healthy, verifying the surface is clean, debriding it, and removing biofilm from it.

Sponsors & Collaborators

  • Pró Circulação®

    lead OTHER

Principal Investigators

  • Eduardo Matta, MD · Pró Circulação®

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2023-11-30
Completion
2025-12-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03127904 on ClinicalTrials.gov