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

University of North Carolina (UNC)

Status

Completed

Conditions

Postphlebitic Syndrome

Venous Stasis Syndrome

Post Thrombotic Syndrome

Venous Insufficiency

Deep Vein Thrombosis

Treatments

Device: VeinOPlus

Study type

Interventional

Funder types

Other

Identifiers

NCT00858130

08-2143Veinoplus

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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