Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot
Conditions
Brief summary
This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).
Detailed description
The VibratoSleeve TUS will be used on to assess its acute vasodilatory and perfusion effects in diabetic subjects with PAD and DFU. Each subject will receive one 90-minute TUS treatment in each of 3 treatment 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
Vascular and Interventional Specialists of Orange County, Inc. (VISOC)
National Institutes of Health (NIH)
Vibrato Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Though the treatment device will be known to all participants, the level of treatment will be randomized among 3 distinct sessions and the level of treatment will be masked for the subject (participant), care provider, investigator, and outcomes assessor.
Intervention model description
Prospective, single arm, open-label, feasibility acute phase study
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Presence of at least one DFU (grade 0 or 1 by University of Texas classification) 2. Diagnosis of diabetes mellitus 3. Diagnosis of PAD that meets at least one of the following conditions: 1. Ankle-brachial index (ABI) of \< 0.9 in the same limb as the DFU 2. Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg 3. Documented history of PAD for a minimum of 3 calendar months prior to time of enrollment 4. Aged ≥ 22 years
Exclusion criteria
1. Rutherford 6 stage PAD 2. Active DFU infection 3. End-stage renal disease on dialysis 4. HbA1c \> 13%. 5. Planned PAD revascularization. 6. Prior stenting in posterior tibial artery. 7. Re-vascularization procedure within 25 days prior to enrollment in the study. (Note: Patients who had re-vascularization procedure earlier than 25 days prior to enrollment are eligible for enrollment if they meet all other criteria). 8. History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease. 9. Acute limb ischemia within 30 days prior to treatment. 10. History or diagnosis of deep venous thrombosis below the knee in treatment leg. 11. Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study or lead to difficulties for patient compliance with study requirements, or could confound study data. 12. Patient's enrollment in another investigational study that has not completed the required primary endpoint follow-up period (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transcutaneous Oxygen Pressure (TcPO2) | Through study completion, an average of 1 month. | noninvasive test that directly measures the oxygen level of tissue beneath the skin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Perfusion Rate of the Targeted Foot | Through study completion, an average of 1 month | Calculate percent change in perfusion rate measured non-invasively by Flowmet, compared from baseline to end of treatment. |
| Tissue Oxygen Saturation (StO2) | Through study completion, an average of 1 month | spatial frequency domain imaging (SFDI) to measure tissue oxygen saturation |
| Ankle Brachial Index (ABI) | Through study completion, an average of 1 month | blood pressure ratio in the upper arm and lower limbs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VibratoSleeve TUS Received treatment with the VibratoSleeve TUS device. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | VibratoSleeve TUS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 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 | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
| Transcutaneous oxygen pressure (TcPO2) | 67.54 mmHg STANDARD_DEVIATION 17.68 |
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
Transcutaneous Oxygen Pressure (TcPO2)
noninvasive test that directly measures the oxygen level of tissue beneath the skin
Time frame: Through study completion, an average of 1 month.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VibratoSleeve TUS | Transcutaneous Oxygen Pressure (TcPO2) | 50.96 mmHg | Standard Deviation 17.4 |
Secondary
Ankle Brachial Index (ABI)
blood pressure ratio in the upper arm and lower limbs
Time frame: Through study completion, an average of 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VibratoSleeve TUS | Ankle Brachial Index (ABI) | 0.92 ratio | Standard Deviation 0.026 |
Secondary
Percent Change From Baseline in Perfusion Rate of the Targeted Foot
Calculate percent change in perfusion rate measured non-invasively by Flowmet, compared from baseline to end of treatment.
Time frame: Through study completion, an average of 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VibratoSleeve TUS | Percent Change From Baseline in Perfusion Rate of the Targeted Foot | 34 Percentage (%) | Standard Deviation 4.6 |
Secondary
Tissue Oxygen Saturation (StO2)
spatial frequency domain imaging (SFDI) to measure tissue oxygen saturation
Time frame: Through study completion, an average of 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VibratoSleeve TUS | Tissue Oxygen Saturation (StO2) | 76.0 Percentage (%) | Standard Deviation 17.2 |