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Oxandrolone to Heal Pressure Ulcers

NCT00101361 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2013-12-20

Study results available
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Summary

This study is designed to determine whether the use of oxandrolone, an anabolic steroid, can heal pressure ulcers in persons with spinal cord injury (SCI). In a Feasibility Study, three VA SCI Units will screen and randomize patients into treatment with oxandrolone or with placebo. Eleven other sites will screen patients to determine eligibility but will not treat patients with the agent. Following the Feasibility Study, all sites will participate in a blinded, randomized treatment study. A total of 400 patients will be enrolled over a four-year period. Any patient in a participating unit who has chronic SCI and a difficult-to-heal pelvic ulcer will be eligible for the study if other entry criteria are met. All enrolled patients will be followed for a period of 24 weeks to determine whether their target pressure ulcers heal. Those who are healed will be followed for an additional four weeks to determine whether the ulcer remains healed.

Conditions

  • Pressure Ulcer

Interventions

DRUG

Oxandrolone

Patients will receive oxandrolone (10mg BID) until full healing occurs or for 24 weeks, which ever comes first.

DRUG

Placebo

Patients will receive an identically appearing placebo capsule until full healing occurs or for 24 weeks, which ever comes first.

Sponsors & Collaborators

Principal Investigators

  • William Bauman, MD · VA Medical Center, Bronx

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States
  • Puerto Rico

Study Locations

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Entities

Drugs
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 NCT00101361 on ClinicalTrials.gov