Beta Blocker for Chronic Wound Healing
The purpose of this study is to evaluate the efficacy and safety of treatment of chronic cutaneous ulcers and burn wounds with topical beta adrenergic antagonists (Timoptic®).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Beta Adrenergic Receptor Modulation of Burn Wound Healing|
- The primary efficacy parameter will be complete ulcer healing, which is defined as 100% epithelialization with no drainage or need for an absorptive dressing. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- 100% re-epithelialization will be clinically determined at each visit by the Investigator. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
This group receives topical beta adrenergic antagonists (Timoptic) plus standard of care.
Timoptic to be applied to the target wound daily for up to 12 weeks.
Other Name: beta adrenergic antagonists
Placebo Comparator: 2
The group will be given standard of care with placebo medication.
Saline solution with no active ingredients to be applied to the target wound daily for up to 12 weeks.
The purpose of this study is to learn more about how to heal venous leg ulcers faster and to test the safety of a drug and see what effects it has on a venous leg ulcer.
- be interviewed and examined
- have a physical exam
- have blood and urine tested
- have photographs taken of the wound
- apply medication to the leg ulcer as directed
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368602
|United States, California|
|VA Medical Center|
|Mather, California, United States, 95655|
|Principal Investigator:||Rivkah R Isseroff, MD||University of California, Davis|