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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
13
Revalesio Part Number MDW0060
Sodium Chloride for Irrigation
Roger Williams Medical Center
Providence, Rhode Island, United States
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
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