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Completed

NCT Number: NCT05145439

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

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

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Key information

Conditions

Diabetic Foot Ulcer Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Injuries Foot Ulcer Leg Injuries Leg Ulcer Peripheral Arterial Disease Peripheral Vascular Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases Wound; Foot Wounds and Injuries

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vascular & Interventional Specialists of Orange County

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

VibratoSleeve Therapeutic Ultrasound Device

Device

The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf.

Primary outcomes

  1. Transcutaneous Oxygen Pressure (TcPO2)

    Time frame: Through study completion, an average of 1 month.

    noninvasive test that directly measures the oxygen level of tissue beneath the skin

Secondary outcomes

  1. Percent Change From Baseline in Perfusion Rate of the Targeted Foot

    Time frame: 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.

  2. Tissue Oxygen Saturation (StO2)

    Time frame: Through study completion, an average of 1 month

    spatial frequency domain imaging (SFDI) to measure tissue oxygen saturation

  3. Ankle Brachial Index (ABI)

    Time frame: Through study completion, an average of 1 month

    blood pressure ratio in the upper arm and lower limbs

Sponsors and collaborators

Lead sponsor

Vibrato Medical, Inc.

Industry

Collaborators

  • National Institutes of Health (NIH)
  • Vascular and Interventional Specialists of Orange County, Inc. (VISOC)

Registry information

Official study 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)

Acronym: Dulcet

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2021
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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