Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome (PTS)

NCT ID: NCT00858130

Last Updated: 2017-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-11-30

Brief Summary

The investigators plan to perform an exploratory study to investigate the effects of electro-stimulation of the legs on the symptoms and clinical findings of post thrombotic syndrome (PTS), as well as quality of life of patients with PTS. The investigators theorize that electro-stimulation will provide both a mechanical benefit via muscular contraction and increased venous outflow from the affected extremity, as well as an anesthetic effect, which the investigators anticipate will translate into improved symptomatic outcomes, quality of life (QOL) benefits.

Detailed Description

The purpose of this study is to determine the optimal electrical stimulation intensity level at which subjects using the portable electrical muscle stimulator (VeinoPlus) have the largest benefit for relief of post thrombotic symptoms. To determine if the subjects reported benefit from the device and willingness to continue using the device.

Subjects will be pre-screened on the phone for eligibility, and an initial appointment will be set. The subject will be given a device and complete a quality of life survey. The subject will also be assessed on the Villalta scale. After two months, the subjects will return for the final visit where the Villalta scale and quality of life survey will be reassessed, and the device taken back.

Conditions

Post Thrombotic Syndrome; Deep Vein Thrombosis; Venous Stasis Syndrome; Venous Insufficiency; Postphlebitic Syndrome

Keywords

Veinoplus; post thrombotic syndrome; deep vein thrombosis; electrical muscle stimulator; Venous stasis syndrome; venous insufficiency syndrome; Postphlebitic syndrome; history of deep vein thrombosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Veinoplus

Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.

Group Type: EXPERIMENTAL

VeinOPlus

Intervention Type: DEVICE

The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months.

Interventions

VeinOPlus

The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age >18
• Presence of previously objectively documented unilateral, lower extremity deep venous thrombosis
• Presence of PTS (typical pain and swelling - worse after standing and vertical activity and relieved by rest and the horizontal position), severe enough that the patient is interested to explore a treatment option that might improve these symptoms. Symptoms had to have been stable for ≥ 3 months. Unstable symptoms are defined as: worsening, improving or variable symptoms over preceding months.
• Subjects must be willing and able to give written informed consent.

Exclusion Criteria

• Inability or refusal to provide informed consent
• Pregnancy
• Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
• Geographic inaccessibility to prevent scheduled return evaluations
• Incapable of responding to questionnaires
• Expected lifespan <6 months
• Presence of cardiac pacemaker
• History of cardiac arrhythmia
• Presence of infected, or inflamed areas or skin eruptions; phlebitis, thrombophlebitis, active venous ulceration
• History of seizures

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

Sponsors

VeinoPlus USA

UNKNOWN

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Moll, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill, Department of Medicine, Division of Hematology/Oncology

Locations

University of North Carolina at Chapel Hill; University of North Carolina Hospitals

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

08-2143Veinoplus

Identifier Type: -

Identifier Source: org_study_id