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
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|ClinicalTrials.gov Identifier: NCT01824407|
Recruitment Status : Unknown
Verified March 2014 by SANUWAVE, Inc..
Recruitment status was: Recruiting
First Posted : April 4, 2013
Last Update Posted : March 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcers||Device: Electrohydraulic-generated shock wave Device: Sham device plus standard of care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||April 2014|
Active Comparator: Active device plus standard of care
Active device plus standard of care
Device: Electrohydraulic-generated shock wave
Other Name: dermaPACE
Sham Comparator: Sham device plus standard of care
dermaPACE device that uses a dummy applicator that does not emit shock waves
Device: Sham device plus standard of care
- Complete closure [ Time Frame: 12 weeks ]Complete closure will be assessed by visual inspection by the principal or sub-investigator according to the following complete closure definition: 100% skin re-epithelializion without drainage or dressing requirements confirmed at two consecutive study visits. A re-epithelialized target ulcer is defined as the tissue surface having at least a thin layer of epithelium covering the prior, previously denuded, target ulcer area.
- Volumetric reduction [ Time Frame: 12 weeks ]Digital planimetry will be used to assess volumetric reduction between follow-up visits.
- Area reduction [ Time Frame: 12 weeks ]Digital planimetry will be used to assess area reduction between follow-up visits.
- Rate of recurrence [ Time Frame: 24 weeks ]
- Rate of amputation and other adverse events [ Time Frame: 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824407