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NCT05145439 | Active, not recruiting | Diabetic Foot Ulcer

A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.
Sponsor:

Vibrato Medical, Inc.

Brief Summary:

This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).

Condition or disease

Diabetic Foot Ulcer

Peripheral Arterial Disease

Wound; Foot

Intervention/treatment

VibratoSleeve Therapeutic Ultrasound Device

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 12 participants
Masking : None (Open Label)
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.
Primary Purpose : Treatment
Official Title : A Non-significant Risk Clinical Study to Assess Changes in Perfusion, Oxygenation, and Hemoglobin Content After Application of the VibratoSleeve, a Therapeutic Ultrasound (TUS) Phased Array, for Patients With Ischemic and Neuroischemic Diabetic Foot Ulcers (DFU)
Actual Study Start Date : January 14, 2023
Estimated Primary Completion Date : September 14, 2023
Estimated Study Completion Date : December 15, 2023
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
Ages Eligible for Study: 22 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Presence of at least one DFU (grade 0 or 1 by University of Texas classification)
  • Diagnosis of diabetes mellitus
  • Diagnosis of PAD that meets at least one of the following conditions
    • Ankle-brachial index (ABI) of < 0.9 in the same limb as the DFU
    • Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg
    • Documented history of PAD for a minimum of 3 calendar months prior to time of enrollment
    • Aged ≥ 22 years
    Exclusion Criteria
    • Rutherford 6 stage PAD
    • Active DFU infection
    • End-stage renal disease on dialysis
    • HbA1c > 13%.
    • Planned PAD revascularization.
    • Prior stenting in posterior tibial artery.
    • 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).
    • History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease.
    • Acute limb ischemia within 30 days prior to treatment.
    • History or diagnosis of deep venous thrombosis below the knee in treatment leg.
    • 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.
    • 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).
A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.

Location Details

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A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Vascular & Interventional Specialists of Orange County

Orange, California, United States, 92868