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

Peripheral Arterial Disease Clinical Trial

— Dulcet  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05145439
• Other study ID #: S21-003
• Status: Completed
• Phase: N/A
• Start date: January 14, 2023
• Est. completion date: December 13, 2023

Study information

• Verified date: April 2024
• Source: Vibrato Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 13, 2023
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Ulcer
• Wound; Foot

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Vascular & Interventional Specialists of Orange County	Orange	California

Sponsors (3)

Lead Sponsor	Collaborator
Vibrato Medical, Inc.	National Institutes of Health (NIH), Vascular and Interventional Specialists of Orange County, Inc. (VISOC)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kalani M, Brismar K, Fagrell B, Ostergren J, Jorneskog G. Transcutaneous oxygen tension and toe blood pressure as predictors for outcome of diabetic foot ulcers. Diabetes Care. 1999 Jan;22(1):147-51. doi: 10.2337/diacare.22.1.147. — View Citation

Yang C, Weng H, Chen L, Yang H, Luo G, Mai L, Jin G, Yan L. Transcutaneous oxygen pressure measurement in diabetic foot ulcers: mean values and cut-point for wound healing. J Wound Ostomy Continence Nurs. 2013 Nov-Dec;40(6):585-9. doi: 10.1097/WON.0b013e3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcutaneous Oxygen Pressure (TcPO2)	TcPO2 is a noninvasive test that directly measures the oxygen level of tissue beneath the skin.	Through study completion, an average of 1 month.
Secondary	Perfusion rate of the targeted foot	Perfusion to be measured with the FlowMet Device (Medtronic)	Through study completion, an average of 1 month
Secondary	DFU tissue oxygenation (StO2) and the hemoglobin content (HbT2)	To be measured with the Clarifi device (Modulim)	Through study completion, an average of 1 month
Secondary	Ankle Brachial Index (ABI)	per institutional standards of care	Through study completion, an average of 1 month