Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Thromboembolisms
Conditions
Brief summary
This is a Phase 2 safety and tolerability trial that will take place in two parts. Part one of the trial will determine the tolerability of the OsciPulse device on healthy subjects who wear the device for up to three hours. Healthy volunteers will answer questionnaires and may undergo an ultrasound test at the end of their participation in the trial. Part two of the trial will determine the safety and tolerability of the OsciPulse device on subjects admitted to Penn Presbyterian Medical Center. Eligible subjects will be enrolled for 6 hours. In the first 3 hours, subjects will wear the standard of care intermittent pneumatic compression device or the OsciPulse device. In the second 3 hours, the subject's device will be switched and subjects will wear the alternate device not used in the first 3 hours. Subjects will answer questionnaires and may undergo an ultrasound at the end of the first 3 hours and at the end of the second 3 hours (at hour 6).
Interventions
DEVICEOsciPulse
OsciPulse device and standard IPC device
Sponsors
OsciFlex LLC
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Two part, open-label, randomized, crossover study. Part 1 will enroll 3 healthy subjects. Part two will enroll 15-20 in-patient subjects. Part two will have two arms. Arm A will wear the OsciPulse then wear the standard IPC device. Arm B will wear the standard IPC device then wear the OsciPulse device.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Part 1: Adult over the age of 40, generally healthy without a current foot or ankle injury, no history of diagnosed vascular disease including DVT, PE, VTE, post-phlebetic syndrome, or chronic venous insufficiency, mentally alert and understand English proficiently, able to give informed consent Part 2: Adult over the age of 18, admitted to the at Penn Presbyterian Medical Center, anticipated decreased level of mobility for at least 6 hours as determined by the clinical team in collaboration with study personnel, mentally alert and understand English proficiently, able to give informed consent.
Exclusion criteria
Part 1: injury to the lower limbs, skin breaks, abrasion, or irritation in the area of the limb in contact with the OsciPulse device. Part 2: 1. Inability or contraindication to applying IPC to both legs such as: * Evidence of bone fracture in lower extremities * Burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis, & ischemic limb in the legs at the site of IPC placement * Acute ischemia in the lower extremities * Severe peripheral vascular disease * Amputated foot or leg on one or two sides * Compartment syndrome * Severe lower extremity edema 2. Subjects anticipated to require surgical intervention within six (6) hours of admission 3. Subjects with history of VTE (DVT or PE) 4. Previous vascular surgery 5. Pregnancy or within 6 weeks of postpartum period 6. Limitation of life support, life expectancy \< 7 days or palliative care 7. Admitted to an outside hospital more than 24 hours prior to screening 8. A head-unit is unavailable for the 6 hours or more 9. At the discretion of the attending physician and / or clinical team, the subject's participation in the study is believed not to be in the best interest of the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 - Subject's Response to Tolerability Questionnaire | up to 3 hours | Tolerability will be measured by subject's response to questionnaires to assess their experience with the device. This will be measured on a linear 100 mm visual acuity scale measured in millimeters. Subjects are provided with the scale and asked to make a mark on the line that corresponds to their experience with the device. The least favorable rating is on the left hand side, the most favorable rating is on the right hand side of the scale. The mark on the line is measured in millimeters, resulting in least favorable scores having a lower score, and most favorable ratings having a higher score. |
| Part 1 - Safety Assessment Through Collection of Adverse Events | up to 3 hours | Safety will be assessed by collecting & reviewing all adverse events while subject is wearing the device. Subjects will indicate if the device caused 1) no discomfort, 2) mild discomfort, or 3) significant discomfort. To move on to Part 2, all subjects in Part 1 must indicate that there was not significant discomfort. |
| Part 2 - Subject's Response to Tolerability Questionnaire | 6 hours | Tolerability will be measured by subject's response to questionnaires to assess their experience with the device. This will be measured on a linear 100mm visual acuity scale measured in millimeters. Subjects are provided with the scale and asked to make a mark on the line that corresponds to their experience with the device. The minimum (least favorable) rating is on the left hand side and is equal to zero (0), the maximum (most favorable) rating is on the right hand side of the scale and is equal to one hundred (100). For Comfort, scores range from very disruptive (0) to no effect (10). For Disruption, scores range from very disruptive (0) to no effect (10). For Noise, scores range from very loud (0) to not noticeable (10). For Movement, scores range from very restrictive (0) to no effect (10). The mark on the line is measured in millimeters, resulting in minimum (least favorable) scores having a lower score, and maximum (most favorable) ratings having a higher score. |
| Part 2 - Safety Assessment Through Collection of Adverse Events. | 6 hours | Safety will be assessed by collecting all adverse events while the subject is wearing the device. |
Countries
United States
Participant flow
Pre-assignment details
Part 1 subjects did NOT go on to Part 2. Part 1 were healthy subjects. Part 2 were patients (not healthy subjects). The study protocol describes the 2 separate groups as part 1 and part 2 of the study, which is why this terminology was used.
Participants by arm
| Arm | Count |
|---|---|
| Part 1, OsciPulse in Healthy Subjects Part 1 subjects only | 3 |
| Part 2, Group A, OsciPulse, Then Standard IPC Group A will wear the OsciPulse device for the first 3 hours then switch to the standard IPC device for the second 3 hours. | 9 |
| Part 2, Group B, Standard IPC, Then OsciPulse Group B will wear the standard IPC device for the first 3 hours then switch to the OsciPulse device for the second 3 hours. | 11 |
| Total | 23 |
Baseline characteristics
| Characteristic | Part 1, OsciPulse in Healthy Subjects | Part 2, Group A, OsciPulse, Then Standard IPC | Part 2, Group B, Standard IPC, Then OsciPulse | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 7 Participants | 9 Participants | 19 Participants |
| Race/Ethnicity, Customized African American | 0 Participants | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 3 Participants | 4 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 3 participants | 9 participants | 11 participants | 23 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 4 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 3 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 3 | 0 / 20 | 1 / 20 |
Outcome results
Primary
Part 1 - Safety Assessment Through Collection of Adverse Events
Safety will be assessed by collecting & reviewing all adverse events while subject is wearing the device. Subjects will indicate if the device caused 1) no discomfort, 2) mild discomfort, or 3) significant discomfort. To move on to Part 2, all subjects in Part 1 must indicate that there was not significant discomfort.
Time frame: up to 3 hours
Population: This outcome measure is applicable to part 1 only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1, Healthy Subjects | Part 1 - Safety Assessment Through Collection of Adverse Events | 0 Participants |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 1 - Safety Assessment Through Collection of Adverse Events | 0 Participants |
| Part 2, Group B, Standard IPC, Then OsciPulse | Part 1 - Safety Assessment Through Collection of Adverse Events | 0 Participants |
Primary
Part 1 - Subject's Response to Tolerability Questionnaire
Tolerability will be measured by subject's response to questionnaires to assess their experience with the device. This will be measured on a linear 100 mm visual acuity scale measured in millimeters. Subjects are provided with the scale and asked to make a mark on the line that corresponds to their experience with the device. The least favorable rating is on the left hand side, the most favorable rating is on the right hand side of the scale. The mark on the line is measured in millimeters, resulting in least favorable scores having a lower score, and most favorable ratings having a higher score.
Time frame: up to 3 hours
Population: This outcome measure is applicable to part 1 only.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1, Healthy Subjects | Part 1 - Subject's Response to Tolerability Questionnaire | Mild discomfort | 0 Participants |
| Part 1, Healthy Subjects | Part 1 - Subject's Response to Tolerability Questionnaire | No discomfort | 3 Participants |
| Part 1, Healthy Subjects | Part 1 - Subject's Response to Tolerability Questionnaire | Significant discomfort | 0 Participants |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 1 - Subject's Response to Tolerability Questionnaire | Mild discomfort | 0 Participants |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 1 - Subject's Response to Tolerability Questionnaire | No discomfort | 0 Participants |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 1 - Subject's Response to Tolerability Questionnaire | Significant discomfort | 0 Participants |
| Part 2, Group B, Standard IPC, Then OsciPulse | Part 1 - Subject's Response to Tolerability Questionnaire | No discomfort | 0 Participants |
| Part 2, Group B, Standard IPC, Then OsciPulse | Part 1 - Subject's Response to Tolerability Questionnaire | Significant discomfort | 0 Participants |
| Part 2, Group B, Standard IPC, Then OsciPulse | Part 1 - Subject's Response to Tolerability Questionnaire | Mild discomfort | 0 Participants |
Primary
Part 2 - Safety Assessment Through Collection of Adverse Events.
Safety will be assessed by collecting all adverse events while the subject is wearing the device.
Time frame: 6 hours
Population: This outcome measure is applicable to part 2 only, which had groups A and B.~The subject consented to Part 2, Group B had an AE prior to being able to use either device. So subject was consented to study but did not have an AE with either standard or investigational device.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1, Healthy Subjects | Part 2 - Safety Assessment Through Collection of Adverse Events. | AEs-OsciPulse | 0 Participants |
| Part 1, Healthy Subjects | Part 2 - Safety Assessment Through Collection of Adverse Events. | No AEs-Standard IPC | 9 Participants |
| Part 1, Healthy Subjects | Part 2 - Safety Assessment Through Collection of Adverse Events. | AEs-Standard IPC | 0 Participants |
| Part 1, Healthy Subjects | Part 2 - Safety Assessment Through Collection of Adverse Events. | AEs-not related to device | 0 Participants |
| Part 1, Healthy Subjects | Part 2 - Safety Assessment Through Collection of Adverse Events. | No AEs-OsciPulse | 9 Participants |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 2 - Safety Assessment Through Collection of Adverse Events. | AEs-not related to device | 1 Participants |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 2 - Safety Assessment Through Collection of Adverse Events. | No AEs-OsciPulse | 10 Participants |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 2 - Safety Assessment Through Collection of Adverse Events. | No AEs-Standard IPC | 10 Participants |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 2 - Safety Assessment Through Collection of Adverse Events. | AEs-OsciPulse | 0 Participants |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 2 - Safety Assessment Through Collection of Adverse Events. | AEs-Standard IPC | 0 Participants |
Primary
Part 2 - Subject's Response to Tolerability Questionnaire
Tolerability will be measured by subject's response to questionnaires to assess their experience with the device. This will be measured on a linear 100mm visual acuity scale measured in millimeters. Subjects are provided with the scale and asked to make a mark on the line that corresponds to their experience with the device. The minimum (least favorable) rating is on the left hand side and is equal to zero (0), the maximum (most favorable) rating is on the right hand side of the scale and is equal to one hundred (100). For Comfort, scores range from very disruptive (0) to no effect (10). For Disruption, scores range from very disruptive (0) to no effect (10). For Noise, scores range from very loud (0) to not noticeable (10). For Movement, scores range from very restrictive (0) to no effect (10). The mark on the line is measured in millimeters, resulting in minimum (least favorable) scores having a lower score, and maximum (most favorable) ratings having a higher score.
Time frame: 6 hours
Population: This outcome measure is applicable to part 2 only, which had groups A and B.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Part 1, Healthy Subjects | Part 2 - Subject's Response to Tolerability Questionnaire | Comfort-OsciPulse | 7.2 score on a scale |
| Part 1, Healthy Subjects | Part 2 - Subject's Response to Tolerability Questionnaire | Comfort-Standard IPC | 6.8 score on a scale |
| Part 1, Healthy Subjects | Part 2 - Subject's Response to Tolerability Questionnaire | Disruption-OsciPulse | 7 score on a scale |
| Part 1, Healthy Subjects | Part 2 - Subject's Response to Tolerability Questionnaire | Disruption-Standard IPC | 7.48 score on a scale |
| Part 1, Healthy Subjects | Part 2 - Subject's Response to Tolerability Questionnaire | Noise-OsciPulse | 3.48 score on a scale |
| Part 1, Healthy Subjects | Part 2 - Subject's Response to Tolerability Questionnaire | Noise-Standard IPC | 7.6 score on a scale |
| Part 1, Healthy Subjects | Part 2 - Subject's Response to Tolerability Questionnaire | Movement Interference-OsciPulse | 5.6 score on a scale |
| Part 1, Healthy Subjects | Part 2 - Subject's Response to Tolerability Questionnaire | Movement Interference-Standard IPC | 4.78 score on a scale |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 2 - Subject's Response to Tolerability Questionnaire | Movement Interference-Standard IPC | 6.7 score on a scale |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 2 - Subject's Response to Tolerability Questionnaire | Comfort-OsciPulse | 6.08 score on a scale |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 2 - Subject's Response to Tolerability Questionnaire | Noise-OsciPulse | 4.08 score on a scale |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 2 - Subject's Response to Tolerability Questionnaire | Comfort-Standard IPC | 9.03 score on a scale |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 2 - Subject's Response to Tolerability Questionnaire | Movement Interference-OsciPulse | 7.15 score on a scale |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 2 - Subject's Response to Tolerability Questionnaire | Disruption-OsciPulse | 4.47 score on a scale |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 2 - Subject's Response to Tolerability Questionnaire | Noise-Standard IPC | 7.05 score on a scale |
| Part 2, Group A, OsciPulse, Then Standard IPC | Part 2 - Subject's Response to Tolerability Questionnaire | Disruption-Standard IPC | 8.18 score on a scale |