Peripheral Arterial Disease
Conditions
Keywords
Therapeutic Ultrasound (TUS), Peripheral Artery Disease (PAD), Critical Limb Ischemia (CLI)
Brief summary
This study is evaluating whether a therapeutic ultrasound device can improve symptoms in the leg of peripheral arterial disease (PAD) patients 65 years of age and over.
Detailed description
The VibratoSleeve TUS will be used on to assess its acute vasodilatory and perfusion effects in subjects with early stage PAD. Each subject will receive TUS treatment multiple sessions. All post- treatment acute assessments will take place immediately following each day's treatment and no follow-up assessments will be required in this study.
Interventions
The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf
Sponsors
Vibrato Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single arm, open-label, feasibility acute phase study
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥ 65 2. Diagnosis of PAD. 3. Claudication symptoms in Rutherford class 1,2, or 3 as determined by the investigator.
Exclusion criteria
1. Prior stenting in posterior tibial artery. 2. Re-vascularization procedure within 30 days prior to enrollment in the study. 3. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf). 4. History or diagnosis of severe chronic venous insufficiency. 5. Acute limb ischemia within 30 days prior to treatment. 6. History or diagnosis of deep venous thrombosis below the knee in treatment leg. 7. Any conditions that, in the opinion of the investigator, may render the subject unable to complete the study or lead to difficulties for subject compliance with study requirements, or could confound study data. 8. Subject's enrollment in another investigational study that has not completed the required primary endpoint follow-up period. stenting in posterior tibial artery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Acute Flow Rate Difference During TUS Treatment Sessions | Baseline to end of treatment, an average of 1 month | Percent change in perfusion measured by FlowMet calculated between baseline and after final treatment. |
| Tissue Oxygen Saturation (StO2) | Through study completion, an average of 1 month | Calculate changes in tissue oxygen saturation (StO2) measured non-invasively by Clarifi spatial frequency domain imaging system, compared from baseline to during and immediately post-treatment. |
| Ankle Brachial Index (ABI) | Baseline to end of treatment, an average of 1 month | ABI is ratio that compares blood pressure in the arm to blood pressure in the ankle. It is a measurement of the extent of peripheral arterial disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Device and Procedure-related Adverse Events | Through study completion, an average of 1 month | Number of adverse events related to the VibratoSleeve device or study procedure occurring throughout the duration of the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TUS Therapy These subjects will undergo treatments with the Vibrato Sleeve TUS device.
VibratoSleeve Therapeutic Ultrasound Device: The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | TUS Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 72.1 years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Ankle Brachial Index (ABI)
ABI is ratio that compares blood pressure in the arm to blood pressure in the ankle. It is a measurement of the extent of peripheral arterial disease.
Time frame: Baseline to end of treatment, an average of 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TUS Therapy | Ankle Brachial Index (ABI) | 0.0 Index (Ratio) | Standard Deviation 0.12 |
Primary
Mean Acute Flow Rate Difference During TUS Treatment Sessions
Percent change in perfusion measured by FlowMet calculated between baseline and after final treatment.
Time frame: Baseline to end of treatment, an average of 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TUS Therapy | Mean Acute Flow Rate Difference During TUS Treatment Sessions | 27.3 Percent change (%) | Standard Deviation 50.8 |
Primary
Tissue Oxygen Saturation (StO2)
Calculate changes in tissue oxygen saturation (StO2) measured non-invasively by Clarifi spatial frequency domain imaging system, compared from baseline to during and immediately post-treatment.
Time frame: Through study completion, an average of 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TUS Therapy | Tissue Oxygen Saturation (StO2) | 1.0 StO2% | Standard Deviation 8.4 |
Secondary
Incidence of Device and Procedure-related Adverse Events
Number of adverse events related to the VibratoSleeve device or study procedure occurring throughout the duration of the study.
Time frame: Through study completion, an average of 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TUS Therapy | Incidence of Device and Procedure-related Adverse Events | 0 Events |