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

NCT05145439 | Completed Results FDA Device

• 1 other identifier: S21-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Foot Ulcer; Peripheral Arterial Disease; Wound; Foot

Outcome Measures

Primary Outcomes (1)

• Transcutaneous Oxygen Pressure (TcPO2)

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

  Through study completion, an average of 1 month.

Secondary Outcomes (3)

• Percent Change From Baseline in Perfusion Rate of the Targeted Foot

  Through study completion, an average of 1 month

• Tissue Oxygen Saturation (StO2)

  Through study completion, an average of 1 month

• Ankle Brachial Index (ABI)

  Through study completion, an average of 1 month

Study Arms (1)

VibratoSleeve TUS

EXPERIMENTAL

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.

Device: VibratoSleeve Therapeutic Ultrasound Device

Interventions

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.

VibratoSleeve TUS

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vibrato Medical, Inc.: lead
• Vascular and Interventional Specialists of Orange County, Inc. (VISOC): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Vascular & Interventional Specialists of Orange County

Orange, California, 92868, United States

Location

Related Publications (2)

• 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.0b013e3182a9a7bf.

  PMID: 24202221 RESULT

• 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.

  PMID: 10333917 RESULT

MeSH Terms

Conditions

Diabetic Foot; Peripheral Arterial Disease; Foot Injuries

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Vice President of Clinical Affairs
• Organization: Vibrato Medical

bisrat@vibratomedical.com

2139215088

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single arm, open-label, feasibility acute phase study

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 6, 2021
• Study Start: January 14, 2023
• Primary Completion: November 10, 2023
• Study Completion: December 13, 2023
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)