Trial Outcomes & Findings for Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome (PTS) (NCT NCT00858130)
NCT ID: NCT00858130
Last Updated: 2017-11-29
Results Overview
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.
COMPLETED
NA
12 participants
Visit 2 (Week 8)
2017-11-29
Participant Flow
Participant milestones
| Measure |
VeinoPlus
Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.
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.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome (PTS)
Baseline characteristics by cohort
| Measure |
VeinoPlus
n=12 Participants
Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.
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.
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|---|---|
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Age, Continuous
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54 years
n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
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Leg Calf Circumference
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41 centimeters (cm)
n=5 Participants
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Villalta Scale
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13 units on a scale
n=5 Participants
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VEINES-Quality of Life (QOL)
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48.30 units on a scale
n=5 Participants
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VEINES-Sym
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46.93 units on a scale
n=5 Participants
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PRIMARY outcome
Timeframe: Visit 2 (Week 8)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.
Outcome measures
| Measure |
VeinoPlus
n=12 Participants
Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.
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.
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Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms
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32 mirco coulombs (0 to 50)
Interval 20.0 to 40.0
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SECONDARY outcome
Timeframe: Visit 2 (Week 8)Clinical success was defined by the patient reporting benefit (moderate improvement of symptoms after having used the device) and an interest and willingness to continue using the device. For this study both legs were measured, but only the more severely affected leg (as determined by higher Villalta score) was used to determine clinical success. Patients were asked the following question: "How much have symptoms improved?" with the following possible responses: "a little;" "moderate;" "a good deal;" "a great deal;" or "a very great deal."
Outcome measures
| Measure |
VeinoPlus
n=12 Participants
Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.
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.
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Number of Study Participants Classified as a "Clinical Success"
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7 Participants
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SECONDARY outcome
Timeframe: Visit 2 (Week 8)The Villalta PTS scale is based on patient symptoms including cramps, pain, and redness and was used to characterize PTS severity. Points are given for 11 descriptors according to severity from 0 (not present) to 3 (severe) with overall scores ranging from 0 to 33. Higher scores represent more severe disease. A score of ≥ 5 indicated mild PTS; 10-14 moderate PTS; and a score of ≥15, or the presence of a venous ulcer, indicated severe PTS. Those participants with a Villalta score decrease at Visit 2 in comparison to Visit 1 were counted as having improved.
Outcome measures
| Measure |
VeinoPlus
n=12 Participants
Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.
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.
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Number of Study Participants With Improvements in PTS Severity (Villalta Score)
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8 Participants
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SECONDARY outcome
Timeframe: Vist 2 (Week 8)The VEINES-QOL/Sym is a patient-based questionnaire designed for self-completion and measures DVT impact on symptoms and QOL from patients' perspective. It contains 26 items covering patient DVT: symptoms, limitations in daily activities, and psychological impact. Two separate summary scores are produced ranging from 0 to 100; a disease-specific QOL (VEINES-QOL) and venous symptoms (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym, higher scores indicate a better QOL. Instruments were completed at Visits 1 and 2 (Follow-up). Those participants with a VEINES-QOL score increase at Visit 2 in comparison to Visit 1 were counted as having improved.
Outcome measures
| Measure |
VeinoPlus
n=12 Participants
Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.
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.
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|---|---|
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Number of Study Participants With Improvements in QOL (VEINES-QOL Score)
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10 Participants
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SECONDARY outcome
Timeframe: Vist 2 (Week 8)The VEINES-QOL/Sym is a patient-based questionnaire designed for self-completion and measures DVT impact on symptoms and QOL from patients' perspective. It contains 26 items covering patient DVT: symptoms, limitations in daily activities, and psychological impact. Two separate summary scores are produced ranging from 0 to 100; a disease-specific QOL (VEINES-QOL) and venous symptoms (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym, higher scores indicate a better QOL. Instruments were completed at Visits 1 and 2 (Follow-up). Those participants with a VEINES-Sym score increase at Visit 2 in comparison to Visit 1 were counted as having improved.
Outcome measures
| Measure |
VeinoPlus
n=12 Participants
Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.
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.
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Number of Study Participants With Improvements in Venous Symptoms (VEINES-Sym Score)
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9 Participants
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Adverse Events
VeinoPlus Experimental Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VeinoPlus Experimental Arm
n=12 participants at risk
Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.
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.
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Skin and subcutaneous tissue disorders
"pinhole leak" near subject's left ankle
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8.3%
1/12 • Number of events 1 • Adverse event data was collected for the entire duration of study subject participation which was 8 weeks.
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Additional Information
Dr. Stephan Moll, Professor of Hemology/Oncology
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place