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Therapeutic Ultrasound
Therapeutic Ultrasound for Diabetic Foot Ulcers (Dulcet Trial)
N/A
Waitlist Available
Research Sponsored by Vibrato Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 month
Awards & highlights
Dulcet Trial Summary
This trial studies if a device that uses sound waves can help improve blood flow in people with diabetic foot ulcers.
Who is the study for?
This trial is for adults aged 22 or older with diabetes and a mild diabetic foot ulcer. They must also have peripheral arterial disease (PAD) confirmed by specific tests like ABI, TBI, or toe blood pressure measurements. People can't join if they have severe kidney disease on dialysis, certain stages of PAD, extremely high HbA1c levels (>13%), recent revascularization procedures, mixed vascular diseases, recent acute limb ischemia, deep vein thrombosis in the treatment leg, or are in another study.Check my eligibility
What is being tested?
The study is testing a therapeutic ultrasound device called VibratoSleeve to see if it improves blood flow in the legs of patients with diabetic foot ulcers. The goal is to determine whether this non-invasive treatment can help heal ulcers by enhancing circulation.See study design
What are the potential side effects?
Since the trial involves a non-significant risk device that uses ultrasound therapy there may be minimal side effects such as slight discomfort at the site of application or skin irritation. However, detailed side effects will be monitored throughout the study.
Dulcet Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Transcutaneous Oxygen Pressure (TcPO2)
Secondary outcome measures
Ankle Brachial Index (ABI)
DFU tissue oxygenation (StO2) and the hemoglobin content (HbT2)
Perfusion rate of the targeted foot
Dulcet Trial Design
1Treatment groups
Experimental Treatment
Group I: VibratoSleeve TUSExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Vibrato Medical, Inc.Lead Sponsor
3 Previous Clinical Trials
54 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
54 Patients Enrolled for Peripheral Arterial Disease
Vascular and Interventional Specialists of Orange County, Inc. (VISOC)UNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
30 Patients Enrolled for Peripheral Arterial Disease
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,567 Total Patients Enrolled
7 Trials studying Peripheral Arterial Disease
718 Patients Enrolled for Peripheral Arterial Disease
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have an infected diabetic foot ulcer.You have severe kidney disease and need dialysis.Criterion: You have a severe stage of peripheral artery disease known as Rutherford 6.Your HbA1c level is higher than 13%.You have a history of severe chronic vein problems or mixed artery-vein disease.You have at least one foot ulcer, but it is not severe.You have diabetes.You are 22 years old or older.You have experienced a serious blockage of blood flow to a limb within the past 30 days.You have a history of blood clots in the lower part of your leg that required treatment.You are scheduled to have a procedure to improve blood flow in your legs.You have a diagnosis of PAD, which can be confirmed by a low ankle-brachial index (ABI) or toe brachial index (TBI) test results, or a documented history of PAD for at least 3 months before enrolling in the study.You have previously had a stent placed in the posterior tibial artery.
Research Study Groups:
This trial has the following groups:- Group 1: VibratoSleeve TUS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies remaining for volunteers in this clinical trial?
"Contrary to expectations, clinicaltrials.gov does not list this trial as currently recruiting patients. Initially posted on January 14th 2023 and edited five months later on May 23rd, unfortunately the study is at a standstill for now; however 614 other trials are actively welcoming new participants."
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