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

Pró Circulação®120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Varicose Ulcer

Interventions

Vein FitnessPROCEDURE

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

Compressive therapy and wound carePROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Pró-Circulação - Clinic of Angiology and Vascular Surgery

Xanxerê, Santa Catarina, Brazil

RECRUITING

Outcomes

Primary Outcomes

Healing of venous ulcer.

Healing is defined as having the ulcer fully covered with scarring tissue.

Time frame: 3 months

Rate of ulcer closure

A ratio of the ulcer area and the time that it takes to close. Ulcer size will be measured using a standard protocol: First, we will photograph the wounds at a standard one meter distance having a ruler besides the lower extremity. The area of each wound will then be estimated through the Imagej software (National Institutes of Health) using a freehand drawing surrounding its border, with software calibration based on the pre-established dimensions of the background image. We will also assess a subset of 20 images by two independent observers to estimate inter-observer reliability.

Time frame: 3 months

Secondary Outcomes

Time-to-closure

The time that it takes for an ulcer to close. Ulcer size will be measured using a standard protocol: First, we will photograph the wounds at a standard one meter distance having a ruler besides the lower extremity. The area of each wound will then be estimated through the Imagej software (National Institutes of Health) using a freehand drawing surrounding its border, with software calibration based on the pre-established dimensions of the background image. We will also assess a subset of 20 images by two independent observers to estimate inter-observer reliability.

Time frame: 3 months

Ankle range of motion

The angle that the ankle can reach as it moves. We will measure ankle range of motion through a goniometer. Specifically, passive ankle motion will be performed, with the fixed arm of the goniometer located on the leg axis, aligning the movable arm with the foot axis. We will perform all procedures in an office setting by trained physical therapists. A random group of patients will have the goniometry procedure performed twice by two independent physical therapists to assess the inter-observer reliability of these metrics.

Time frame: 3 months

Central Contacts

Eduardo Matta, MD

CONTACT

55 (49) 3433-9050 procirculacao@gmail.com

Clodoaldo A. De Sá, Ph.D.

CONTACT

55 (49) 3321-8215

Data from ClinicalTrials.gov

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