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

NCT00858130 | Completed Results DMC FDA Device

• 1 other identifier: 08-2143Veinoplus
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Post Thrombotic Syndrome; Deep Vein Thrombosis; Venous Stasis Syndrome; Venous Insufficiency; Postphlebitic Syndrome

Keywords

Veinoplus; post thrombotic syndrome; deep vein thrombosis; electrical muscle stimulator; Venous stasis syndrome; venous insufficiency syndrome; Postphlebitic syndrome; history of deep vein thrombosis

Outcome Measures

Primary Outcomes (1)

• Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms

  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 subjects to choose their own level and change the stimulations during the treatment cycle if desired. The intensity ranges from zero to fifty, with zero being no electrical stimulation, and fifty the highest intensity, which carries low quantities of electrical energy (\<5 micro coulombs). In this study subjects used the device at any setting, as many times a day as they liked, and varying the placement of the electrodes.

  Visit 2 (Week 8)

Secondary Outcomes (4)

• Number of Study Participants Classified as a "Clinical Success"

  Visit 2 (Week 8)

• Number of Study Participants With Improvements in PTS Severity (Villalta Score)

  Visit 2 (Week 8)

• Number of Study Participants With Improvements in QOL (VEINES-QOL Score)

  Vist 2 (Week 8)

• Number of Study Participants With Improvements in Venous Symptoms (VEINES-Sym Score)

  Vist 2 (Week 8)

Study Arms (1)

Veinoplus

EXPERIMENTAL

Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.

Device: VeinOPlus

Interventions

VeinOPlus DEVICE

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.

Veinoplus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• VeinoPlus USA: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill; University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Postthrombotic Syndrome; Venous Thrombosis; Venous Insufficiency; Postphlebitic Syndrome

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Phlebitis; Peripheral Vascular Diseases

Limitations and Caveats

Given its small sample size (n=12), this study provides rationale and details needed for a larger randomized, placebo controlled, and double-blinded trial.

Results Point of Contact

• Title: Dr. Stephan Moll, Professor of Hemology/Oncology
• Organization: University of North Carolina at Chapel Hill

stephan_moll@med.unc.edu

919-966-3311

Study Officials

• Stephan Moll, MD

  UNC Chapel Hill, Department of Medicine, Division of Hematology/Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients were told to use different voltages and numbers of treatment periods, and experiment with pad placement, to find intensity, frequency of use, and pad position for optimal PTS symptom relief. Assessments (Villalta score, QOL questionnaire, calf circumference) were obtained at study entry and after 8 weeks of device use.

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 9, 2009
• Study Start: March 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 29, 2017
• Results First Posted: November 29, 2017

Record last verified: 2017-08

Locations

US (1)