Document Detail


A randomized phase II trial of Arginine Butyrate with standard local therapy in refractory sickle cell leg ulcers.
MedLine Citation:
PMID:  20955402     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Sickle cell leg ulcers are often debilitating, refractory to healing, and prone to recurrence. Healing of leg ulcers was incidentally observed during dose-ranging trials of Arginine Butyrate in beta haemoglobinopathies. Here, a controlled Phase II trial was performed in sickle cell patients who had lower extremity ulcers refractory to standard care for at least 6 months. Patients were randomized to receive standard local care alone (Control Arm) or standard care with Arginine Butyrate administered 5 d/week (Treatment Arm), for 12 weeks. Ulcers were photographed weekly, traced, and ulcer areas were calculated by computerized planimetry and compared between the two study arms. Twenty-seven study courses were evaluated. Control Arm subjects had 25 ulcers with a mean area of 25·7 cm(2) initially and 23·2 cm(2) after 12 weeks; 2/25 (8%) healed completely. Treatment Arm subjects had 37 ulcers with a mean area of 50·6 cm(2) initially and 28·3 cm(2) at 12 weeks; 11/37 of these (30%) healed completely. After 3 months, proportions of ulcers which healed were 6/25 (24%) and 29/37 (78%), in the Control and Treatment Arms respectively (P < 0·001). These findings strongly suggest that Arginine Butyrate merits further evaluation for the treatment of refractory sickle cell leg ulcers in larger trials.
Authors:
Lillian McMahon; Hannah Tamary; Melissa Askin; Patricia Adams-Graves; Robert T Eberhardt; Millicent Sutton; Elizabeth C Wright; Serguei A Castaneda; Douglas V Faller; Susan P Perrine
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.     Date:  2010-10-19
Journal Detail:
Title:  British journal of haematology     Volume:  151     ISSN:  1365-2141     ISO Abbreviation:  Br. J. Haematol.     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-11-12     Completed Date:  2011-01-03     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372544     Medline TA:  Br J Haematol     Country:  England    
Other Details:
Languages:  eng     Pagination:  516-24     Citation Subset:  IM    
Copyright Information:
© 2010 Blackwell Publishing Ltd.
Affiliation:
Cancer Center and Hemoglobinopathy Thalassemia Research Unit, Boston University School of Medicine, Boston, MA 02118, USA.
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MeSH Terms
Descriptor/Qualifier:
Adult
Anemia, Sickle Cell / complications*
Arginine / analogs & derivatives*,  therapeutic use
Butyrates / therapeutic use*
Chronic Disease
Female
Humans
Leg Ulcer / drug therapy*,  etiology,  pathology
Male
Middle Aged
Prospective Studies
Treatment Outcome
Wound Healing / drug effects
Young Adult
Grant Support
ID/Acronym/Agency:
FD-R-000176/FD/FDA HHS; M01 RR00533/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Butyrates; 74-79-3/Arginine; 80407-72-3/arginine butyrate

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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