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Pulsed Acoustic Cellular Expression Device

Sound Wave Therapy for Diabetic Foot Ulcers

Phase 3
Waitlist Available
Research Sponsored by SANUWAVE, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If female of child-bearing potential, practices one of the following methods of contraception and continues through the duration of the study: hormonal contraceptives, IUD, spermicide and barrier or implantable device, and has a negative urine qualitative beta-HCG pregnancy test
Has at least one DFU that is located in the ankle area or below that has persisted a minimum of 30 days prior to Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial is testing whether a sound wave device can help heal diabetic foot ulcers. The device has not been approved for this use, so it is considered investigational. The trial will compare the device to a sham device to see if it is more effective.

Who is the study for?
Adults over 22 with Type I or II Diabetes and a diabetic foot ulcer between 1.0 cm2 and 16 cm2 that's lasted at least 30 days can join this trial. They must have certain blood flow levels in their legs, an HbA1c <=11%, and use contraception if applicable. Exclusions include nursing women, recent deep vein thrombosis patients, those with severe kidney disease or infections near the ulcer, among others.Check my eligibility
What is being tested?
The study tests the dermaPACE® device which uses sound waves to potentially help heal diabetic foot ulcers versus a sham (inactive) device. Both are used alongside standard care for ulcers to see if there's a difference in healing speed.See study design
What are the potential side effects?
Potential side effects aren't specified but may include discomfort at the treatment site due to acoustic pressure waves from the dermaPACE® device or issues related to not receiving active treatment with the sham device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am using effective birth control and my pregnancy test is negative.
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I have a foot ulcer below my ankle that has lasted for over 30 days.
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I have diabetes with an HbA1c level of 11% or less.
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My ulcer is between 1.0 and 16 cm2 in size.
Select...
My leg's blood flow measurements are within the required range.
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I am 22 years old or older.
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I am a woman who cannot become pregnant due to surgery or being postmenopausal for at least one year.
Select...
My diabetic foot ulcer is mild to moderate.
Select...
I can take care of my wounds at home.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete closure
Secondary outcome measures
Area reduction
Rate of amputation and other adverse events
Rate of recurrence
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active device plus standard of careActive Control1 Intervention
Active device plus standard of care
Group II: Sham device plus standard of carePlacebo Group1 Intervention
dermaPACE device that uses a dummy applicator that does not emit shock waves

Find a Location

Who is running the clinical trial?

SANUWAVE, Inc.Lead Sponsor
2 Previous Clinical Trials
208 Total Patients Enrolled
2 Trials studying Foot Ulcer
208 Patients Enrolled for Foot Ulcer

Media Library

dermaPACE® (Pulsed Acoustic Cellular Expression Device) Clinical Trial Eligibility Overview. Trial Name: NCT01824407 — Phase 3
Foot Ulcer Research Study Groups: Active device plus standard of care, Sham device plus standard of care
Foot Ulcer Clinical Trial 2023: dermaPACE® Highlights & Side Effects. Trial Name: NCT01824407 — Phase 3
dermaPACE® (Pulsed Acoustic Cellular Expression Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01824407 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the Active device plus standard of care most commonly used to treat patients?

"The Active device plus standard of care intervention has undergone multiple rounds of testing, meaning that there is a significant amount of safety data. This, in turn, gives the Active device plus standard of care a score of 3."

Answered by AI

Are there many different medical clinics testing this new medication within the state?

"If you are interesting in enrolling in this trial, know that there are 19 different sites currently participating. These locations include Oakland, Hialeah and San Bernardino; to name a few. If you want to limit your travel, it might be best to select the site that is nearest to your home."

Answered by AI

Are enrollment numbers still high for this test program?

"This clinical trial is not actively recruiting patients at this time. However, it is worth noting that the trial was originally posted on 2013-03-01 and was last edited on 2014-03-04. Additionally, there are 396 other studies presently enrolling patients."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
~7 spots leftby Mar 2025