The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury: a randomized trial.

BACKGROUND: Anabolic steroids have been reported to improve wound healing. OBJECTIVE: To determine whether oxandrolone increases the percentage of target pressure ulcers (TPUs) that heal compared with placebo and whether healed ulcers remain closed 8 weeks after treatment. DESIGN: Parallel-group, placebo-controlled, randomized trial conducted from 1 August 2005 to 30 November 2008. Patients, clinical care providers, study personnel, and statisticians were blinded to treatment assignment. (ClinicalTrials.gov: NCT00101361). SETTING: 16 inpatient spinal cord injury (SCI) services at Veterans Affairs medical centers. PATIENTS: 1900 prescreened, 779 screened, and 212 randomly assigned inpatients with SCI and stage III or IV TPUs. INTERVENTION: Oxandrolone, 20 mg/d (n = 108), or placebo (n = 104) until the TPU healed or 24 weeks. MEASUREMENTS: The primary outcome was healed TPUs. The secondary outcome was the percentage of TPUs that remained healed at 8-week follow-up. RESULTS: 24.1% (95% CI, 16.0% to 32.1%) of TPUs in oxandrolone recipients and 29.8% (CI, 21.0% to 38.6%) in placebo recipients healed (difference, -5.7 percentage points [CI, -17.5 to 6.8 percentage points]; P = 0.40). At 8-week follow-up, 16.7% (CI, 9.6% to 23.7%) of oxandrolone recipients and 15.4% (CI, 8.5% to 22.3%) of placebo recipients retained a healed TPU (difference, 1.3 percentage points [CI, -8.8 to 11.2 percentage points]; P = 0.70). No serious adverse events were related to oxandrolone. Liver enzyme levels were elevated in 32.4% (CI, 23.6% to 41.2%) of oxandrolone recipients and 2.9% (CI, 0.0% to 6.1%) of placebo recipients (P < 0.001). LIMITATIONS: Selection of severe wounds may have reduced treatment response. Approximately one third of patients did not complete the study in the treatment and placebo groups. The study was terminated after a futility analysis showed a low probability of detecting a significant difference between the groups. CONCLUSION: Oxandrolone showed no benefit over placebo for improving healing or the percentage of TPUs that remained closed after 8 weeks of treatment. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs.

Upper limb strength: study providing normative data for a clinical handheld dynamometer.

OBJECTIVE: To establish normative clinical data for upper extremity strength of men and women, ages 20-64 years, using a portable clinical device, the Nicholas Manual Muscle Tester (NMMT). DESIGN: The study collected objective upper extremity strength data for 180 healthy men and women using the NMMT. SETTING: The study was conducted in outpatient and community settings. SUBJECTS: One hundred eighty normal volunteers (90 men and 90 women). METHODS: Eleven upper extremity muscle groups were tested using standardized methodology. MAIN OUTCOME MEASUREMENTS: Data were recorded for each muscle group in each subject. RESULTS: This study presents data from 180 healthy, normal subjects, equally divided by gender and age. Means ± standard deviations were determined for each group and further categorized by age, gender, and hand dominance. These data confirm some expected patterns: In all the muscle groups men have significantly higher strength than women, and the dominant side is stronger than the nondominant side in men and women. Relative values for various muscle groups are analyzed and presented. CONCLUSIONS: This study provides an initial normative database across a wide age range in men and women for upper extremity strength for monitoring clinical care and research for injured and impaired patients. These data are an essential and initial step toward comprehensive normative databases for upper extremity objective ordinal strength measurements with the NMMT.