Oxandrolone to Heal Pressure Ulcers
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||CSP #535 - Anabolic Steroid Therapy on Pressure Ulcer Healing in Persons With Spinal Cord Injury|
- A Healed Pressure Ulcer [ Time Frame: healing was measured from randomization to full healing or 24 weeks, whichever occured first. ] [ Designated as safety issue: No ]Patients remained in treatment until full healing of the target pressure ulcer (defined as re-epithelialization to a cicatrix with a dry surface and zero open area for a minimum of 96 hours) or 24 weeks, whichever occured first.
|Study Start Date:||August 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Patients will receive oxandrolone (10mg BID) until full healing occurs or for 24 weeks, which ever comes first.
Placebo Comparator: 2
Patients will receive an identically appearing placebo capsule until full healing occurs or for 24 weeks, which ever comes first.
The primary objective is to determine whether SCI inpatients with a chronic Stage III or IV pressure ulcer of the pelvic region who are randomized to receive 24 weeks of optimized clinical care and an oral anabolic steroid agent (oxandrolone) will have a greater percent of healed pressure ulcers than those who receive placebo and the same optimized clinical care. The major secondary objective is to determine whether the healed pressure ulcer will remain healed for at least 8 weeks.
Subjects are registered into a 4 week screening phase to be followed with weekly photos of the ulcer and if healed less than 30% (from the day 1 photo to the day 28 photo) with standard clinical care, they are introduced to the treatment phase (randomized) and followed for another 24 weeks on either oxandrolone or placebo. Wounds that heal (remain closed for at least 96 hours) are then subject to 2 four week follow up visits.
Criteria for entering the screening phase are simple: either gender, age 18 years or older, inpatient with SCI or equivalent spinal cord damage and at least 1 Stage III or IV (indicating a severe wound, <260cm2) pressure ulcer of the pelvic region.
September 2006 - year one report submitted and approved by Central Office. Plan to add up to 3 more sites in the next year.
January 2007 - site #16 (San Antonio) is approved by Veterans Affairs Cooperative Studies Program Central Office to be invited.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101361
|United States, California|
|VA Medical Center, Long Beach|
|Long Beach, California, United States, 90822|
|VA Palo Alto Health Care System|
|Palo Alto, California, United States, 94304-1290|
|VA San Diego Healthcare System, San Diego|
|San Diego, California, United States, 92161|
|United States, Florida|
|VA Medical Center, Miami|
|Miami, Florida, United States, 33125|
|James A. Haley Veterans Hospital, Tampa|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|VA Medical Center, Augusta|
|Augusta, Georgia, United States, 30904|
|United States, Illinois|
|Edward Hines, Jr. VA Hospital|
|Hines, Illinois, United States, 60141-5000|
|United States, Massachusetts|
|VA Boston Healthcare System, Brockton Campus|
|Brockton, Massachusetts, United States, 02301|
|United States, Missouri|
|VA Medical Center, St Louis|
|St Louis, Missouri, United States, 63106|
|United States, New York|
|VA Medical Center, Bronx|
|Bronx, New York, United States, 10468|
|United States, Ohio|
|VA Medical Center, Cleveland|
|Cleveland, Ohio, United States, 44106|
|United States, Texas|
|VA North Texas Health Care System, Dallas|
|Dallas, Texas, United States, 75216|
|Michael E. DeBakey VA Medical Center (152)|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|Hunter Holmes McGuire VA Medical Center|
|Richmond, Virginia, United States, 23249|
|United States, Wisconsin|
|Zablocki VA Medical Center, Milwaukee|
|Milwaukee, Wisconsin, United States, 53295-1000|
|VA Medical Center, San Juan|
|San Juan, Puerto Rico, 00921|
|Study Chair:||William Bauman, MD||VA Medical Center, Bronx|