Oxandrolone to Heal Pressure Ulcers

Inclusion Criteria:

SCREENING PHASE:

1. Male or female inpatient with SCI or equivalent spinal cord damage.
2. At least one Stage III or IV (including a severe wound, <260cm2) pressure ulcer of the pelvic region.

TREATMENT PHASE:

1. documentation (through screening phase) of difficult to heal (defined as <30% area reduction) or worsening status of the pressure ulcer for at least 28 days as inpatient (screening phase)

Exclusion Criteria:

SCREENING PHASE:

1. Persons who are candidates for and elect to have reconstructive flap surgery of the TPU;
2. Persons with known osteomyelitis who have not been, or refuse to be, adequately treated with appropriate antibiotic treatment for at least 6 weeks and/or appropriate surgical procedures, as determined by the patients' physician, as well as patients who have not had resolution of osteomyelitis after 3 months of antibiotic and/or surgical care.
3. Psychopathology (documentation in the medical record or history of self-abusive behavior specific to pressure ulcer healing which may or may not include major or minor psychiatric illness) that may conflict with study objectives;
4. Previously diagnosed active malignant disease;
5. Suspicion of skin cancer at the pressure ulcer site (a biopsy-negative patient is not excluded, nor is a biopsy-positive patient excluded after a curative excision of the lesion);
6. Radiation therapy in the pressure ulcer field at anytime during the patient's lifetime;
7. Life expectancy less than 12 months;
8. Nephrosis, hemodialysis or chronic ambulatory peritoneal dialysis therapy;
9. AIDS patients at immunological risk of infectious complications defined as any of the following: (1) CD4 count <100 cells/ L or (2) CD4 count 100 to 200 cells/ L and WBC < 4,000 cells/ L or (3) a confirmed viral load within the past 6 months;
10. Administration of oxandrolone or another anabolic agent (not including testosterone replacement therapy) within the past 6 months;
11. A known hypersensitivity to anabolic steroid medications (specifically oxandrolone);
12. Coronary athersclerosis with unstable angina pectoris or a history within the past 3 months of an acute myocardial event or decompensated congestive heart failure.
13. Inability or unwillingness of the subject or surrogate to provide informed consent.

TREATMENT PHASE:

1. TPU >200 cm2 surface area of the pelvic region
2. Pressure ulcers with a clinical impression that are not expected to heal, such as those with: osteomyelitis (defined as persons with known osteomyelitis who have not been, or refuse to be, adequately treated with appropriate antibiotic treatment for at least 6 weeks and/or appropriate surgical procedures, as determined by the patients' physician, as well as patients who have not had resolution of osteomyelitis after 3 months of antibiotic and/or surgical care), sinus tracts suggestive of active osteomyelitis, communication to the synovial space, or other conditions;
3. Patient had flap surgery of the TPU during the Screening Phase;
4. Multiple full-thickness pressure ulcers that have a body surface area totaling >500cm2;
5. Clinical and/or laboratory evidence suggestive of prostate cancer;
6. Elevated liver function tests (AST >112 IU/L or bilirubin >3mg/dl);
7. Diabetes mellitus with less than optimal glycemic control (HbA1c >8.0%);
8. Received moderate (equivalent to prednisone 40 to 60 mg/d) or high dose (equivalent to prednisone >60 mg/d) systemic corticosteroids for at least 4 weeks, immunosuppressive agents, anti-cancer agents, or any radiation therapy within 30 days prior to randomization or are likely to receive one of these therapies during study participation;
9. Initiating or continuing therapy with appetite stimulants (e.g., Megase);
10. Current pharmacological therapy for hepatitis B or C infection;
11. Pregnancy or lactating female;
12. Females of child-bearing potential who are unwilling to agree to abstinence from sexual intercourse or the use of two reliable forms of contraception during the study; males unwilling to agree to abstinence from sexual intercourse or use of a condom during the study;
13. Expected use of oral anticoagulants (e.g. warfarin sodium) during the treatment phase;
14. Hypercalcemia;
15. Coronary athersclerosis with unstable angina pectoris or a history within the past 3 months of an acute myocardial event or decompensated congestive heart failure;
16. Participation in another active treatment clinical trial;
17. Inability or unwillingness of the subject or surrogate to provide informed consent.