Oxandrolone to Heal Pressure Ulcers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00101361|
Recruitment Status : Terminated (futility analysis showed low probability of detecting a significant difference)
First Posted : January 10, 2005
Results First Posted : November 25, 2013
Last Update Posted : December 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcer||Drug: Oxandrolone Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||212 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||CSP #535 - Anabolic Steroid Therapy on Pressure Ulcer Healing in Persons With Spinal Cord Injury|
|Study Start Date :||August 2005|
|Primary Completion Date :||December 2008|
|Study Completion Date :||December 2008|
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.
- A Healed Pressure Ulcer [ Time Frame: healing was measured from randomization to full healing or 24 weeks, whichever occured first. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|