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

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Mar 6, 2009

Keywords

ClinConnect Summary

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...

Gender

ALL

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