Status:
COMPLETED
Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome (PTS)
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
VeinoPlus USA
Conditions:
Post Thrombotic Syndrome
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00858130
Start Date
March 1 2009
End Date
November 1 2009
Last Update
November 29 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of North Carolina at Chapel Hill; University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599