Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 13, 2009
June 22, 2012
March 2008
October 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00823446 on ClinicalTrials.gov Archive Site
  • Wound edge healing rate [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • Complete Wound Closure [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers
A Feasibility, Double Blind, Randomized, Controlled Clinical Study to Evaluate the Safety of Topically Applied Revera vs. Control in Subjects With Venous Leg Ulcers.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Venous Stasis Ulcers
  • Device: Revera Wound Care
    Revalesio Part Number MDW0060
  • Device: Normal Saline
    Sodium Chloride for Irrigation
  • Experimental: Revera Wound Care
    Intervention: Device: Revera Wound Care
  • Placebo Comparator: Normal Saline
    Intervention: Device: Normal Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00823446
RC 03.1.1.HS1
No
Revalesio Corporation
Revalesio Corporation
Not Provided
Not Provided
Revalesio Corporation
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP