At a glance
ClinicalIndex Comparison Record- ✓Confirmed sickle cell syndrome (HbSS, S-beta thalassemia, or hemoglobin variants)
- ✓Lower extremity or ankle ulcer present for at least 6 months without healing
- ✓Age 16-60 years
- ✓Transaminases ≤250 IU
- ✕Chronic transfusion therapy
- ✕Prior or concurrent cancer chemotherapy
- ✕Concurrent butyrate derivatives
- ✕Concurrent corticosteroid therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Arginine Butyrate for Treatment of Refractory Leg Ulcers in Sickle Cell Disease or Beta Thalassemia
In Brief
A Phase 2 clinical trial evaluating Arginine Butyrate and Standard local care dressing for Skin Ulcers and Sickle Cell Anemia. Completed, enrolled 23 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
To determine if Arginine Butyrate accelerates healing of refractory leg ulcers over Standard Local Care alone.
To heal leg ulcers.