Study to Determine if Shock Wave Therapy Applied to Traumatic Wounds of the Extremity Improves Healing Time
NCT00486733 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 213
Last updated 2012-12-20
Summary
The purpose of this study is to determine if adding shock wave therapy to standard-of-care wound treatment for traumatic extremity wounds helps them heal faster.
Conditions
- Soft Tissue Injuries
Interventions
- DEVICE
-
DermaGold
The first four follow-up study assessment and data collection points will coincide with scheduled operative interventions on the wound guided by clinical situation and the treating physician's judgment (approximately every 3-4 days). Subsequent follow-up study assessment and data collection points will occur on study days 28 ± 3, 42 ± 3, 60 ± 3, and 90 ± 3.
Sponsors & Collaborators
-
Tissue Regeneration Technologies
collaborator INDUSTRY -
Walter Reed Army Medical Center
lead FED
Principal Investigators
-
Alexander Stojadinovic, MD · Walter Reed Army Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-04-30
- Primary Completion
- 2014-10-31
- Completion
- 2014-12-31
Countries
- United States
Study Locations
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