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Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers

NCT00004412 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2015-03-31

Study results available
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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.

Conditions

Interventions

DRUG

Arginine Butyrate

To determine if Arginine Butyrate accelerates healing of refractory leg ulcers over Standard Local Care alone.

OTHER

Standard local care dressing

To heal leg ulcers.

Sponsors & Collaborators

  • Boston Medical Center

    collaborator OTHER

  • University of Illinois at Chicago

    collaborator OTHER

  • Icahn School of Medicine at Mount Sinai

    collaborator OTHER

  • University of Tennessee

    collaborator OTHER

  • Schneider Children's Medical Center, Israel

    collaborator OTHER

  • Susan P. Perrine

    lead OTHER

Principal Investigators

  • Douglas V. Faller · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-09-30
Primary Completion
2002-12-31
Completion
2005-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004412 on ClinicalTrials.gov