A Comparison of the dermaPACE® (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care Versus Standard of Care Alone in the Treatment of Diabetic Foot Ulcers
Public ClinicalTrials.gov record NCT01824407. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Multi-center, Randomized, Sham-Controlled, Parallel Group Comparison of the dermaPACE® (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care Versus Standard of Care Alone in the Treatment of Diabetic Foot Ulcers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The Sponsor of this study, SANUWAVE, Inc., has developed an investigational device known as the dermaPACE® (Pulsed Acoustic Cellular Expression) device for the possible treatment of diabetic foot ulcers. This device generates acoustic (sound) pressure waves designed to act on the cells in your body to generate proteins that may lead to wound closure. The dermaPACE® device has not been approved for the treatment of diabetic foot ulcers; therefore its use in this study is investigational. The purpose of the study is to evaluate the ability of the dermaPACE® device to help diabetic foot ulcers heal more quickly. The active study device, the dermaPACE®, will be compared to an inactive look-alike device (called a "Sham") in this study. The sham device will not provide any treatment to your diabetic foot ulcer.
Study identification
- NCT ID
- NCT01824407
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 90 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2013
- Primary completion
- Mar 31, 2014
- Completion
- Not listed
- Last update posted
- Mar 5, 2014
Started 2013
United States locations
- U.S. sites
- 18
- U.S. states
- 9
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Associated Foot and Ankle Specialists | Phoenix | Arizona | 85015 | Recruiting |
| Southern Arizona VA Healthcare System | Tucson | Arizona | 85723 | Recruiting |
| Long Beach VA Healthcare System | Long Beach | California | 90822 | Recruiting |
| Foot and Ankle Clinic | Los Angeles | California | 90010 | Recruiting |
| Alameda County Medical Center - Highlands Campus | Oakland | California | 94602 | Recruiting |
| Lucius J. Hill DPM | San Bernardino | California | 92404 | Recruiting |
| Paul and Margaret Brand Research Center at Barry University | Hialeah | Florida | 33013 | Recruiting |
| The Research Center | Hialeah | Florida | 33016 | Recruiting |
| River City Clinical Research | Jacksonville | Florida | 32207 | Recruiting |
| St. Paul Medical Research | Miami | Florida | 33126 | Recruiting |
| Advanced Pharma CR | Miami | Florida | 33137 | Recruiting |
| Northwestern University, Div of Plastic and Reconstructive Surgery | Chicago | Illinois | 60611 | Recruiting |
| Foot Healthcare Associates | Southfield | Michigan | 48076 | Recruiting |
| Moore Foot and Ankle Specialists | Asheville | North Carolina | 28806 | Recruiting |
| Wound Center - ACMH | Kittaning | Pennsylvania | 16201 | Recruiting |
| Podiatric Medical Partners of Texas | Dallas | Texas | 75224 | Recruiting |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| Foot and Ankle Associates of SW Virginia | Roanoke | Virginia | 24016 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01824407, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 5, 2014 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01824407 live on ClinicalTrials.gov.