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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
Pró-Circulação - Clinic of Angiology and Vascular Surgery
RECRUITING
Xanxerê
Contact Information
Primary
Eduardo Matta, MD
procirculacao@gmail.com
55 (49) 3433-9050
Backup
Clodoaldo A. De Sá, Ph.D.
55 (49) 3321-8215
Time Frame
Start Date: 2018-07-24
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 120
Treatments
Experimental: Vein Fitness
Lymphomiokinetic exercises will be performed during a 1 hour period, with the patients in a supine position, legs elevated and properly positioned on a carpet; the knees will be mildly flexed to a comfortable point. The patients will put feet on the pedals of ankle extension/flexion device. The frequency will be around 15 to 20 cycles/minute, while the amplitude will be individually adjusted according to the range of movement of each patient. During the exercises, study personnel will manually drain the lower members.~Compressive therapy will be applied as described in the control group arm.~Care of the wound will be delivered as described in the control group arm.
Active_comparator: Control group
Compressive therapy will be applied to both groups by properly trained personnel. Each layer of the compressive boot will have a 50% overlap, from the base to of the fingers to 3 cm bellow the popliteal fossa. The interface pressure used will be of at least 50mmHg in supine position.~Wound care will be delivered to every individual in both groups, 1 or 2 times each week by a nurse certified in wound management, following the principles of maintenance of a moisturized surface between the wound and its cover. The nurse will also carry out mechanical wound debriding and biofilm removal.
Related Therapeutic Areas
Sponsors
Leads: Pró Circulação®

This content was sourced from clinicaltrials.gov