N/A
N=12
A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.
Diabetic Foot Ulcer · Peripheral Arterial Disease · Wound; Foot
Bottom Line
View on ClinicalTrials.gov: NCT05145439 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Transcutaneous Oxygen Pressure (TcPO2) — 50.96 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VibratoSleeve Therapeutic Ultrasound Device (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Vibrato Medical, Inc.
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Transcutaneous Oxygen Pressure (TcPO2) |
50.96 | — |
| SECONDARY Percent Change From Baseline in Perfusion Rate of the Targeted Foot |
34 | — |
| SECONDARY Tissue Oxygen Saturation (StO2) |
76.0 | — |
| SECONDARY Ankle Brachial Index (ABI) |
0.92 | — |
Summary
This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).
Eligibility 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 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).
Data sourced from ClinicalTrials.gov (NCT05145439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.