A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.
Study Details
Study Description
Brief Summary
Prospective, single arm, open-label clinical trial to evaluate the feasibility of TUS in the treatment of DFU, with a blinded and randomized order of the three different treatment levels (low, medium, and high acoustic intensities, corresponding to different peak negative pressures). VibratoSleeve is an array of single element ultrasound transducers, driven in a phased manner, and held in place externally by an adjustable sleeve. In this study, the VibratoSleeve will be applied in a clinic setting and will be tested to demonstrate evidence of an increase in distal limb perfusion in adult subjects with ischemic and neuroischemic DFU.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
In this Dulcet clinical study, the VibratoSleeve TUS will be used on to assess its acute vasodilatory and perfusion effects in a series of up to 12 evaluable diabetic subjects with PAD and DFU. TUS will be delivered a wound care clinic, following debridement and wound assessment. Each subject will receive one 90-minute TUS treatment in each of 3 treatment sessions. Only one treatment level will be applied per session, at either low, medium, or high acoustic intensity corresponding to peak negative pressures. The order of treatments will be randomized; and subjects and research staff will be blinded as to the order of each subject's treatments.
This pilot study is designed only to address acute changes in perfusion with each dose-finding TUS treatment. After pre-treatment imaging, the VibratoSleeve device will be fitted to the posterior calf and coupled to skin with ultrasound gel. Therapy will be initiated using a Vibrato generator, gradually increasing acoustic output over the first 5 minutes of therapy until reaching the pre-determined randomized level, while assessing patient comfort throughout.
All 3 individual one-day, 90-minute treatments will be carried out with at least a one-week interval between each treatment session. 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. This is entirely an acute-phase investigation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VibratoSleeve TUS In this single arm study, there is only one group/arm, all of whom will be given 3 levels of treatment with the VibratoSleeve TUS device. |
Device: VibratoSleeve Therapeutic Ultrasound Device
The VibratoSleeve consists of four strips (two with five transducers, and two with three transducers) comprising a 16-transducer array that is mounted within a neoprene wrap that conforms to the posterior calf.
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Outcome Measures
Primary Outcome Measures
- Transcutaneous Oxygen Pressure (TcPO2) [Through study completion, an average of 1 month.]
TcPO2 is a noninvasive test that directly measures the oxygen level of tissue beneath the skin. The test is painless for the subject and is measured by placing and inflating a cuff over the targeted ulcerative site, then slowly deflating it and identifying the cuff pressure at which the microcirculatory blood perfusion returns. The blood perfusion is detected using a laser Doppler probe.
Secondary Outcome Measures
- Perfusion rate to the 1st digit of the targeted foot [Through study completion, an average of 1 month.]
Perfusion to be measured with the FlowMet Device (Medtronic)
- DFU tissue oxygenation (StO2) and the hemoglobin content (HbT2) [Through study completion, an average of 1 month.]
To be measured with the Clarifi device (Modulim)
- Ankle Brachial Index (ABI) [Through study completion, an average of 1 month.]
per institutional standards of care
Eligibility Criteria
Criteria
Inclusion Criteria:
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Presence of at least one DFU (grade 0 or 1 by University of Texas classification).8,9
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Diagnosis of diabetes mellitus.
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Diagnosis of PAD.
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Ankle-brachial index (ABI) of < 0.9 in the same limb as the DFU.
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Aged ≥ 22 years.
Exclusion Criteria:
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Rutherford 6 stage PAD
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Active DFU infection
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End-stage renal disease on dialysis
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HbA1c > 13%.
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Planned PAD revascularization.
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Prior stenting in posterior tibial artery.
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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).
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History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease.
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Acute limb ischemia within 30 days prior to treatment.
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History or diagnosis of deep venous thrombosis below the knee in treatment leg.
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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.
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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).
NOTE: Eligibility for patients with bi-lateral PAD will be assessed based on the leg that has more advanced PAD and DFU. For bi-lateral PAD patients only one leg with the more disease will be treated.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Vibrato Medical, Inc.
- Vascular and Interventional Specialists of Orange County, Inc. (VISOC)
- National Institutes of Health (NIH)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Dulcet