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Short Chain Fatty Acid

Crossover for Sickle Cell Anemia

Phase 2
Waitlist Available
Research Sponsored by Susan P. Perrine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants were followed for an average of 3 months
Awards & highlights

Summary

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.

Eligible Conditions
  • Sickle Cell Anemia
  • Skin Ulcer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants were followed for an average of 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants were followed for an average of 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Healing Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area
Secondary outcome measures
% Ulcers Which Completely Healed in Each Group, After 3 Months

Trial Design

3Treatment groups
Experimental Treatment
Group I: Standard local care dressingExperimental Treatment1 Intervention
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.
Group II: CrossoverExperimental Treatment2 Interventions
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.
Group III: Arginine ButyrateExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arginine Butyrate
1997
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

University of Tennessee Health Science CenterOTHER
48 Previous Clinical Trials
25,081 Total Patients Enrolled
Susan P. PerrineLead Sponsor
Boston Medical CenterOTHER
389 Previous Clinical Trials
874,397 Total Patients Enrolled
~1 spots leftby Jul 2025
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