CompletedNot Applicable

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

United States12 participantsStarted 2023-01-14

Plain-language summary

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

Age range22 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Transcutaneous Oxygen Pressure (TcPO2)

Timeframe: Through study completion, an average of 1 month.

NCT IDNCT05145439

SponsorVibrato Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-10

Results submitted2025-03-14