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

Varicose Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03127904
• Other study ID #: Procirculacao1
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2018
• Est. completion date: December 30, 2025

Study information

• Verified date: September 2022
• Source: Pró Circulação®
• Contact: Eduardo Matta, MD
• Phone: 55 (49) 3433-9050
• Email: procirculacao[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2025
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer

Intervention

Procedure:
• Vein Fitness
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
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.

Locations

Country	Name	City	State
Brazil	Pró-Circulação - Clinic of Angiology and Vascular Surgery	Xanxerê	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
Pró Circulação®

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing of venous ulcer.	Healing is defined as having the ulcer fully covered with scarring tissue.	3 months
Primary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	Leg strength	The stand-up test will be used to measure the force of the inferior limb	3 months
Secondary	Health-related quality of Life	Heath related quality of life will be assessed with a validated Portuguese version of the SF-36 (Short-Form Health Survey) tool.	3 months
Secondary	Leg perimetry	Perimetry will be conducted at two different levels of the foot, and at five distinct levels of the leg, using a regular commercial tape. No pressure will be applied to these measurements to avoid affecting their precision. We will conduct the first-foot measurement five centimeters proximal to the base of the first proximal phalanx of the second toe, and the second measurement five centimeters proximal to the first measure. The first leg measurement will be performed five centimeters above the inferior border of the lateral malleolus, and then followed at every five centimeters to a total of six to eight measurements depending on the leg height.	3 months
Secondary	Barthel Index	An ordinal scale used to measure performance in activities of daily living (ADL). Ten variables evaluating ADL and mobility are scored. Each item is rated in terms of whether the individual can perform the task independently, with some assistance, or is dependent on help based on observation (0=unable, 1=needs help, 2=independent). The final score is x 5 to get a number on a 100 point score. SScores of 0-20 indicate "total" dependency, 21-60 represents "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.	3 months
Secondary	Lawton-Brody Instrumental Activities of Daily Living (iADL)	Used to assess independent living skills of an individual and measures functional ability. Each item is rated trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and the score is the sum of the responses. The higher the score, the greater the person's abilities.	3 months
Secondary	Physical Activity Questionnaire (IPAQ)	IPAQ assesses physical activity undertaken across a comprehensive set of domains, including leisure-time physical activity, domestic and gardening (yard) activities, work-related physical activity, and transport-related physical activity. The score is obtained by the sum of the duration (in minutes) and frequency (days) for all the types of activities in all domains. A higher score represents a higher level of physical activity.	3 months
Secondary	Interface Pressure (IP)	Defined as the pressure exerted by the compression system over the surface of skin.	3 months
Secondary	Static Stiffness Index (SSI)	Defined as the difference between standing and resting pressure	3 months
Secondary	Working Pressure Amplitude (WPA)	Considered as the difference between the lowest and highest interface pressure recorded during flexion and extension movements.	3 months