Sponsor study identifier
Secondary identifiers
OTHER · Food & Drug Administration
OTHER · Food & Drug Administration
interventional
23
1 country
4
Study Start
September 1997
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2002
Actual (reported)Study Completion
February 2005
Actual (reported)OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2005
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1997
Date type not reportedThis date has not been verified as actual or estimated.
October 18, 1999
Actual (reported)October 19, 1999
Actual (reported)December 2002
Actual (reported)February 2005
Actual (reported)March 31, 2015
Actual (reported)Healing Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area
Treatment Arm: The AB is given as an IV infusion at 500 mg/kg over 6-9 hrs. 5 days per week for 12 weeks. After 12 weeks of therapy, if he ulcer has decreased by 25% , the AB may be continued for additional 8 weeks (twice) or, until ulcer closes plus 2 weeks, additionally. Ulcers photographed, traced, and ulcer areas calculated by computerized planimetry.
participants were followed for an average of 3 months
% Ulcers Which Completely Healed in Each Group, After 3 Months
two additional courses of 8 week cycles
Each subject provided his/her own dressing e.g,standard local care includes cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 500 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 6 to 12hours.
To determine if Arginine Butyrate accelerates healing of refractory leg ulcers over Standard Local Care alone.
To heal leg ulcers.
University of Illinois College of Medicine
Chicago, Illinois, 60612, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103, United States
McMahon L, Tamary H, Askin M, Adams-Graves P, Eberhardt RT, Sutton M, Wright EC, Castaneda SA, Faller DV, Perrine SP. A randomized phase II trial of Arginine Butyrate with standard local therapy in refractory sickle cell leg ulcers. Br J Haematol. 2010 Dec;151(5):516-24. doi: 10.1111/j.1365-2141.2010.08395.x. Epub 2010 Oct 19.
Douglas V. Faller
Boston University
23 participants (actual enrollment reported by the registry).
First Submitted
October 18, 1999
First Posted
October 19, 1999
Study Start
September 1997
Date type not reportedThis date has not been verified as actual or estimated.
Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain
Patients are randomly assigned (following a table of random numbers prepared by a blinded statistician) between two arms of the study. Arm I is Standard local care dressing only, and Arm II is standard local care plus Arginine Butyrate (AB), the Investigational New Drug. Ulcers observed \& traced weekly. Ulcer area calculated by computerized planimetry. After 12 weeks of therapy, if the ulcer size decreased by at least 25%, the AB may be continued for another 8 weeks (twice), or until the ulcer closes, plus an additional 2 weeks. The patients randomized to the Control Arm (standard local care) were given the option of crossing over to Arm II If, ulcers did not close after 8 weeks of standard local care.
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Primary Completion
December 2002
Actual (reported)Study Completion
February 2005
Actual (reported)Last Updated
March 31, 2015
Results First Posted
March 31, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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