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

NCT03127904 | Unknown

• 1 other identifier: Procirculacao1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Ulcer

Keywords

Varicose ulcer; Compressive therapy; Venous ulcer; Chronic venous disease

Outcome Measures

Primary Outcomes (2)

• Healing of venous ulcer.

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

  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.

  3 months

Secondary Outcomes (11)

• Time-to-closure

  3 months

• Ankle range of motion

  3 months

• Leg strength

  3 months

• Health-related quality of Life

  3 months

• Leg perimetry

  3 months

Study Arms (2)

Vein Fitness

EXPERIMENTAL

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.

Procedure: Vein Fitness; Procedure: Compressive therapy and wound care

Control group

ACTIVE COMPARATOR

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.

Procedure: Compressive therapy and wound care

Interventions

Vein Fitness PROCEDURE

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

Vein Fitness

Compressive therapy and wound care 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; Vein Fitness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pró Circulação®: lead

Study Sites (1)

Pró-Circulação - Clinic of Angiology and Vascular Surgery

Xanxerê, Santa Catarina, 89.820-000, Brazil

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eduardo Matta, MD

  Pró Circulação®

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo Matta, MD

CONTACT

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

Clodoaldo A. De Sá, Ph.D.

CONTACT

55 (49) 3321-8215

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Outcome evaluators and data scientists will be blinded regarding randomization. Blinding will be ensured by asking investigators at the end of the trial if investigators knew the arm to which each subject was going to be allocated prior to opening the envelope.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 25, 2017
• Study Start: July 24, 2018
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2025
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)