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NCT00858130 · ClinicalTrials.gov registry record · NA
Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome (PTS)
A NA study of Deep Vein Thrombosis and Venous Insufficiency, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT00858130: Completed NA study of Deep Vein Thrombosis and Venous Insufficiency, sponsored by University of North Carolina, Chapel Hill.
NCT00858130 is a NA study of Deep Vein Thrombosis and Venous Insufficiency that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 12 participants, below the 7,931-participant average among 24 other Deep Vein Thrombosis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00858130, a NA study of Deep Vein Thrombosis and Venous Insufficiency, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The VeinoPlus® electrically stimulates leg muscles via motor nerves, causing muscle contractions. Two electrode pads are placed on the skin of the leg. Pad positions can be chosen by the patient, such as (a) both pads on the calf muscle of one leg, (b) one pad on the calf muscle and one on the plantar aspect of the foot of one leg, and (c) a pad posteriorly on each calf. Length of treatment is programmed into the device and is 20 minutes. The device has a variable intensity setting which allows
Conditions Studied
Interventions
- DEVICE VeinOPlus
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill; University of North Carolina Hospitals - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-03 |
| Est. Completion | 2009-11 |
| Phase | NA |
What the finished NCT00858130 record still lists
NCT00858130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 7,931-participant average among 24 other Deep Vein Thrombosis trials with a reported enrollment target (100% lower).
The record links to 5 conditions, with Deep Vein Thrombosis appearing as the primary indexed condition, and to 1 intervention - of which VeinOPlus is the first listed.
NCT00858130 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00858130 about?
NCT00858130 is a clinical study titled "Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome (PTS)". 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 prov...
What is the current status of trial NCT00858130?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2009-03. Estimated completion is 2009-11.
What conditions does trial NCT00858130 study?
This clinical trial studies the following conditions: Deep Vein Thrombosis, Venous Insufficiency, Post-Thrombotic Syndrome, Postphlebitic Syndrome, Venous Stasis Syndrome.
What interventions are being tested in trial NCT00858130?
The interventions under investigation include: VeinOPlus (DEVICE).
Who is sponsoring clinical trial NCT00858130?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00858130 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00858130's enrollment target sits among peer trials
12 25th of 24 the lowest of 24 other Deep Vein Thrombosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Deep Vein Thrombosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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