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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-14

Study Completion Date

2023-12-13

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diabetic Foot Ulcer Peripheral Arterial Disease Wound; Foot

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, single arm, open-label, feasibility acute phase study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

VibratoSleeve Therapeutic Ultrasound Device

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No