Oxandrolone to Heal Pressure Ulcers
Condition: Pressure Ulcer
MeSH terms: Pressure Ulcer; Ulcer
Intervention: Oxandrolone; Placebo
Intervention description: Patients will receive oxandrolone (10mg BID) until full healing occurs or for 24 weeks, which ever comes first.; Patients will receive an identically appearing placebo capsule until full healing occurs or for 24 weeks, which ever comes first.
Intervention MeSH terms: Oxandrolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 212.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dermatologic; skin; clinical trial; androgen/anabolic

Summary:

      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.
    

Eligibility criteria:

        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.