N/A
N=12
Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome (PTS)
Post Thrombotic Syndrome · Deep Vein Thrombosis · Venous Stasis Syndrome · Venous Insufficiency · Postphlebitic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00858130 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms — 32 mirco coulombs (0 to 50)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VeinOPlus (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms |
32 | — |
| SECONDARY Number of Study Participants Classified as a "Clinical Success" |
7 | — |
| SECONDARY Number of Study Participants With Improvements in PTS Severity (Villalta Score) |
8 | — |
| SECONDARY Number of Study Participants With Improvements in QOL (VEINES-QOL Score) |
10 | — |
| SECONDARY Number of Study Participants With Improvements in Venous Symptoms (VEINES-Sym Score) |
9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00858130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.