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

Completed · Not applicable

Conditions studied: Post Thrombotic Syndrome, Deep Vein Thrombosis, Venous Stasis Syndrome, Venous Insufficiency, Postphlebitic Syndrome

In brief

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.

Key facts

Study ID

NCT00858130

Run by

University of North Carolina, Chapel Hill

People needed

12

Starts

2009-03-01

Expected to finish

2009-11-01

Last updated by the study team

2017-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of North Carolina at Chapel Hill; University of North Carolina Hospitals — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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