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.

Condition	Treatment or Intervention	Phase
Spinal Cord Injury	Drug: Oxandrolone	Phase III

Further Study Details: 

Expected Total Enrollment:  400

The primary objective is to determine whether SCI inpatients with a chronic Stage III or IV pressure ulcer of the pelvic region who receive 24 weeks of optimized clinical care (i.e., guideline-driven care with nutritional support) and an oral anabolic steroid agent (oxandrolone) will have a greater percent of healed pressure ulcers than those who receive placebo and the same standards of clinical care. The major secondary objective is to determine whether the healed pressure ulcer will remain closed for 8 weeks. This is a five-year prospective, randomized, double blind, placebo-controlled clinical trial. Patients with chronic SCI who have a difficult-to-heal pressure ulcer on the pelvic region and meet all inclusion/exclusion criteria will be randomized to either the anabolic agent or placebo treatment at each participating site. Pressure ulcer size (area/volume) and characteristics will be measured by commercial digital imaging technology with a computer software database component.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

SCREENING PHASE:

• Male or female inpatient with SCI or equivalent spinal cord damage.
• At least one Stage III or IV (including a severe wound, <230 cm^2) pressure ulcer of the pelvic region.

TREATMENT PHASE:

• Documentation (through screening phase) of difficult to heal (defined as <15% area reduction) or worsening status of the pressure ulcer for at least 28 days as inpatient (screening phase)

California
      Long Beach VAMC, Long Beach,  California,  90822,  United States; Recruiting
      Palo Alto VAMC, Palo Alto,  California,  94304,  United States; Recruiting
Florida
      Tampa VAMC, Tampa,  Florida,  33612,  United States; Recruiting
Georgia
      Augusta VAMC, Augusta,  Georgia,  30904,  United States; Recruiting
Illinois
      Hines VAMC, Hines,  Illinois,  60141,  United States; Recruiting
Massachusetts
      Boston VAMC - West Roxbury Division, West Roxbury,  Massachusetts,  02132,  United States; Suspended
Missouri
      St. Louis VAMC, St. Louis,  Missouri,  63125,  United States; Recruiting
New York
      Bronx VAMC, Bronx,  New York,  10468,  United States; Recruiting
Ohio
      Cleveland VAMC, Cleveland,  Ohio,  44106,  United States; No longer recruiting
Texas
      Dallas VAMC, Dallas,  Texas,  75216,  United States; Recruiting
      Houston VAMC, Houston,  Texas,  77030,  United States; Recruiting
Virginia
      Richmond VAMC, Richmond,  Virginia,  23249,  United States; Recruiting
Washington
      Seattle VAMC, Seattle,  Washington,  98108,  United States; Terminated
Wisconsin
      Milwaukee VAMC, Milwaukee,  Wisconsin,  53295,  United States; Recruiting
Puerto Rico
      San Juan VAMC, San Juan,  00921,  Puerto Rico; Recruiting

Study ID Numbers:  535
Record last reviewed:  January 2005
Last Updated:  February 17, 2005
Record first received:  January 7, 2005
ClinicalTrials.gov Identifier:  NCT00101361
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08