Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers
|Venous Stasis Ulcers||Device: Revera Wound Care Device: Normal Saline||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Feasibility, Double Blind, Randomized, Controlled Clinical Study to Evaluate the Safety of Topically Applied Revera vs. Control in Subjects With Venous Leg Ulcers.|
- Tabulations of AEs (Adverse Event), review of CBC (Complete Blood Count) with differential and platelet. [ Time Frame: CBC at initial screening and completion of dose regiment (8 weeks). AE's evaluated per protocol if and when they occur. ]
- Wound edge healing rate [ Time Frame: Weekly ]
- Complete Wound Closure [ Time Frame: Weekly ]
|Study Start Date:||March 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
|Experimental: Revera Wound Care||
Device: Revera Wound Care
Revalesio Part Number MDW0060
|Placebo Comparator: Normal Saline||
Device: Normal Saline
Sodium Chloride for Irrigation
The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.
This evaluation will be done through tabulations of adverse events (AE), review of complete blood counts (CBC) with differential and platelet, and measuring wound healing rate.
The secondary purpose of the study is a preliminary evaluation of an increase in the healing rate of venous leg ulcers treated with Revera Wound Care.
This evaluation will be done through measuring wound healing rate (which is also being used to evaluate safety) and complete wound healing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823446
|United States, Rhode Island|
|Roger Williams Medical Center|
|Providence, Rhode Island, United States, 02908|