Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-30 @ 10:52 AM
Study NCT ID:
NCT03127904
Status:
RECRUITING
Last Update Posted:
2022-09-28
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vein Fitness System vs Compressive Therapy for Venous Ulcers: a Bayesian Adaptive Trial
Sponsor:
Pró Circulação®
Organization:
Study Overview
Official Title:
Pragmatic, Bayesian Adaptive Trial Comparing the Venfit System Against Standard Compressive Therapy in the Treatment of Venous Ulcers
Status:
RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: