At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 206 enrolled
Drug / intervention
acoustical pulse energy (extracorporeal shockwave) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Use of the dermaPACE™ (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care in the Treatment of Diabetic Foot Ulcers
In Brief
A Phase 3 clinical trial evaluating acoustical pulse energy (extracorporeal shockwave) and Sham for Diabetic Foot Ulcers. Completed, enrolled 206 participants across 23 sites in 3 countries.
Detailed Summary
The purpose of this study is to compare the safety and effectiveness of the dermaPACE Device to sham application, when administered in conjunction with standard treatments used in the treatment of DFUs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcers
CountriesGermany, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2007
Enrollment StartOct 2007
Primary CompletionJun 2010
Study CompletionSep 2010
TodayJul 2026
First PostedSep 28, 2007
Enrollment StartOct 1, 2007
Primary CompletionJun 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 18.8 years ago
Interventions
acoustical pulse energy (extracorporeal shockwave)device
Acoustical pulse energy (extracorporeal shockwave) + Standard of care wound dressing.
Shamother
Non-energized (inactive - Sham) application + standard of care