Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis
This study has been withdrawn prior to enrollment.
(Study terminated due to no subject enrollment.)
KCI USA, Inc.
Information provided by:
KCI USA, Inc.
First received: October 5, 2005
Last updated: August 19, 2013
Last verified: August 2013
The purpose of this study is to determine:
- If vacuum assisted closure (VAC®) therapy results in altered proteomic expression of angiogenic markers compared to moist wound therapy.
- If VAC® therapy results in increased angiogenesis compared to moist wound therapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Study Comparing Vacuum Assisted Closure® Therapy to Moist Wound Therapy in Angiogenesis|
Further study details as provided by KCI USA, Inc.:
Primary Outcome Measures:
- Altered proteomic expression evaluated by angiogenic markers using biomolecular assays of biopsy samples at Day 0, Day 3, Day 7, Day 21, and Day 28
Secondary Outcome Measures:
- Increased angiogenesis of the lower extremity wound will be quantified using the MicroScan™ (video microscope) at Day 0, Day 3, Day 7, Day 21, Day 28, Day 42, and at follow up visit.
|Study Start Date:||September 2005|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
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