Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome
This study has been completed.
Sponsor:
Stephan Moll, MD
Collaborators:
Clinical and Translational Research Center at UNC Hospitals
VeinoPlus USA
Information provided by (Responsible Party):
Stephan Moll, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00858130
First received: March 5, 2009
Last updated: September 17, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Post Thrombotic Syndrome Deep Vein Thrombosis Venous Stasis Syndrome Venous Insufficiency Postphlebitic Syndrome |
Device: VeinOPlus |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Optimal Intensity and Frequency of a Portable Electrical Muscle Stimulator (VeinoPlus) to Improve Symptoms of Postthrombotic Syndrome |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- Estimate the optimal electrical stimulation intensity level at which patients using the portable electrical muscle stimulator (VeinoPlus®) have the largest benefit for relief of symptoms. [ Time Frame: visit 2 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Estimate whether use of the device was a "clinical success" as defined by the patient reporting benefit by the improvement of symptoms after having used the device, plus an interest and willingness to continue using the device. [ Time Frame: visit 2 ] [ Designated as safety issue: No ]
- Estimate the extent to which the portable electrical muscle stimulator (VeinoPlus) improves the quality of life and objective findings of postthrombotic syndrome. [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
- Compute information needed to power a future cross-over study. [ Time Frame: after all visits completed ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | March 2009 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Veinoplus
Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.
|
Device: VeinOPlus
The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months.
Other Name: Veinoplus
|
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 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 subjects will return for the final visit where the Villalta scale and quality of life survey will be reassessed, and the device taken back.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858130
Locations
| United States, North Carolina | |
| University of North Carolina at Chapel Hill; University of North Carolina Hospitals | |
| Chapel Hill, North Carolina, United States, 27599 | |
Sponsors and Collaborators
Stephan Moll, MD
Clinical and Translational Research Center at UNC Hospitals
VeinoPlus USA
Investigators
| Principal Investigator: | Stephan Moll, MD | UNC Chapel Hill, Department of Medicine, Division of Hematology/Oncology |
More Information
No publications provided
| Responsible Party: | Stephan Moll, MD, Associate Professor, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00858130 History of Changes |
| Other Study ID Numbers: | 08-2143Veinoplus |
| Study First Received: | March 5, 2009 |
| Last Updated: | September 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
Veinoplus post thrombotic syndrome deep vein thrombosis electrical muscle stimulator |
Venous stasis syndrome venous insufficiency syndrome Postphlebitic syndrome history of deep vein thrombosis |
Additional relevant MeSH terms:
|
Blind Loop Syndrome Postphlebitic Syndrome Postthrombotic Syndrome Varicose Ulcer Thrombosis Venous Insufficiency Venous Thrombosis Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Metabolic Diseases Phlebitis Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Embolism and Thrombosis Varicose Veins Leg Ulcer Skin Ulcer Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013