Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Revalesio Corporation

ClinicalTrials.gov Identifier:

NCT00823446

First received: January 13, 2009

Last updated: June 22, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 13, 2009
Last Updated Date	June 22, 2012
Start Date ^ICMJE	March 2008
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 13, 2009)	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. ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00823446 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 13, 2009)	Wound edge healing rate [ Time Frame: Weekly ] [ Designated as safety issue: Yes ] Complete Wound Closure [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers
Official Title ^ICMJE	A Feasibility, Double Blind, Randomized, Controlled Clinical Study to Evaluate the Safety of Topically Applied Revera vs. Control in Subjects With Venous Leg Ulcers.
Brief Summary	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.
Detailed Description	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 ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Venous Stasis Ulcers
Intervention ^ICMJE	Device: Revera Wound Care Revalesio Part Number MDW0060 Device: Normal Saline Sodium Chloride for Irrigation
Study Arm (s)	Experimental: Revera Wound Care Intervention: Device: Revera Wound Care Placebo Comparator: Normal Saline Intervention: Device: Normal Saline
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	13
Completion Date	October 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 18 years of age or older. Diagnosis of non-healing venous leg ulcer by the following criteria: dependent peripheral edema, dermatitis, hyperpigmentation. an ankle to arm arterial pressure ratio > 0.7 as measured by arterial Doppler. Venous Stasis Ulcer is ≥ 2 cm² in size. If female subject of reproductive age, have had a negative pregnancy test within one week of study entry and are using adequate birth control. Exclusion Criteria: Subject known to be allergic to Aquacel dressing or components. Peripheral arterial insufficiency (as determined by Doppler ABI), uncontrolled congestive heart failure (CHF), vasculitis, uncontrolled diabetes mellitus. Severe contact dermatitis (allowable if it does not interfere with application of the dressings). Concomitantly receiving systemic corticosteroids in doses exceeding 20 mg per day. Involvement in another experimental drug trial within the last month. Clinical evidence of cellulitis or infection in or around the ulcer. History of non-compliance to medical regimens and is not considered reliable. Unable to understand the study evaluations and provide a written informed consent.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00823446
Other Study ID Numbers ^ICMJE	RC 03.1.1.HS1
Has Data Monitoring Committee	No
Responsible Party	Revalesio Corporation
Study Sponsor ^ICMJE	Revalesio Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Revalesio Corporation
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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