Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers
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|ClinicalTrials.gov Identifier: NCT00823446|
Recruitment Status : Completed
First Posted : January 15, 2009
Last Update Posted : June 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Venous Stasis Ulcers||Device: Revera Wound Care Device: Normal Saline||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
|Experimental: Revera Wound Care||
Device: Revera Wound Care
Revalesio Part Number MDW0060
|Placebo Comparator: Normal Saline||
Device: Normal Saline
Sodium Chloride for Irrigation
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823446
|United States, Rhode Island|
|Roger Williams Medical Center|
|Providence, Rhode Island, United States, 02908|