Diabetic Foot Ulcers Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02652754 -
Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Diabetic Foot Ulcers
|
Phase 1 | |
| Completed |
NCT01070433 -
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers
|
Phase 2 | |
| Completed |
NCT00971048 -
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
|
N/A | |
| Terminated |
NCT00762138 -
The AutoloGel™ Post-Market Surveillance (TAPS) Program
|
N/A | |
| Completed |
NCT00578604 -
Non-Invasive Assessment of Wound Healing With Optical Methods
|
N/A | |
| Completed |
NCT05417425 -
Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
|
Phase 1 | |
| Completed |
NCT02631512 -
Evaluation of Woulgan in Diabetic Foot Ulcer
|
Phase 4 | |
| Completed |
NCT02222376 -
Effect of Topic Pirfenidone in Diabetic Ulcers
|
Phase 3 | |
| Terminated |
NCT01816633 -
Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers
|
N/A | |
| Completed |
NCT01221207 -
Instant Total Contact Cast to Heal Diabetic Foot Ulcers
|
N/A | |
| Completed |
NCT01454401 -
LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
|
N/A | |
| Completed |
NCT01291160 -
Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers
|
Phase 2/Phase 3 | |
| Withdrawn |
NCT01105884 -
Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers
|
N/A | |
| Completed |
NCT00536744 -
Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers
|
Phase 3 | |
| Terminated |
NCT00316537 -
Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers
|
Phase 1/Phase 2 | |
| Completed |
NCT00013299 -
Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3
|
Phase 2 | |
| Completed |
NCT00013286 -
A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk
|
Phase 2 | |
| Terminated |
NCT02667327 -
A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer
|
Phase 3 | |
| Not yet recruiting |
NCT00916292 -
Safety Study of Topical Human FGF-1 for Wound Healing
|
Phase 1 | |
| Completed |
NCT01154374 -
A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)
|
Phase 2 |