Clinical trial NCT03127904: Vein Fitness System vs Compressive Therapy for Venous Ulcers: a Bayesian Adaptive Trial
Official title: Pragmatic, Bayesian Adaptive Trial Comparing the Venfit System Against Standard Compressive Therapy in the Treatment of Venous Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Varicose Ulcer
Keywords: Varicose ulcer
Compressive therapy
Venous ulcer
Chronic venous disease
Lead sponsor: Pró Circulação®
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Healing of venous ulcer.
timeFrame: 3 months
measure: Rate of ulcer closure
timeFrame: 3 months
Secondary outcomes:
measure: Time-to-closure
timeFrame: 3 months
measure: Ankle range of motion
timeFrame: 3 months
measure: Leg strength
timeFrame: 3 months
measure: Health-related quality of Life
timeFrame: 3 months
measure: Leg perimetry
timeFrame: 3 months
measure: Barthel Index
timeFrame: 3 months
measure: Lawton-Brody Instrumental Activities of Daily Living (iADL)
timeFrame: 3 months
measure: Physical Activity Questionnaire (IPAQ)
timeFrame: 3 months
measure: Interface Pressure (IP)
timeFrame: 3 months
measure: Static Stiffness Index (SSI)
timeFrame: 3 months
measure: Working Pressure Amplitude (WPA)
timeFrame: 3 months
Other outcomes:
Locations:
city: Xanxerê
country: Brazil
facility: Pró-Circulação - Clinic of Angiology and Vascular Surgery
state: Santa Catarina
Study officials:
affiliation: Pró Circulação®
name: Eduardo Matta, MD
role: PRINCIPAL_INVESTIGATOR
References: