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

NCT ID: NCT03127904

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-24
• Study Completion Date: 2025-12-30

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.

Conditions

Varicose Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Vein Fitness

Intervention Type: PROCEDURE

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

Compressive therapy and wound care

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Compressive therapy and wound care

Intervention Type: PROCEDURE

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.

Interventions

Vein Fitness

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

Intervention Type: 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.

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pró Circulação®

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo Matta, MD

Role: PRINCIPAL_INVESTIGATOR

Pró Circulação®

Locations

Pró-Circulação - Clinic of Angiology and Vascular Surgery

Xanxerê, Santa Catarina, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Eduardo Matta, MD

Role: CONTACT

procirculacao@gmail.com

55 (49) 3433-9050

Clodoaldo A. De Sá, Ph.D.

Role: CONTACT

55 (49) 3321-8215

Facility Contacts

Eduardo Matta

Role: primary

Other Identifiers

Procirculacao1

Identifier Type: -

Identifier Source: org_study_id