Status:
TERMINATED
Oxandrolone to Heal Pressure Ulcers
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Pressure Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 w...
Detailed Description
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...
Eligibility Criteria
Inclusion
- SCREENING PHASE:
- Male or female inpatient with SCI or equivalent spinal cord damage.
- 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
- SCREENING PHASE:
- Persons who are candidates for and elect to have reconstructive flap surgery of the TPU;
- 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.
- 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;
- Previously diagnosed active malignant disease;
- 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);
- Radiation therapy in the pressure ulcer field at anytime during the patient's lifetime;
- Life expectancy less than 12 months;
- Nephrosis, hemodialysis or chronic ambulatory peritoneal dialysis therapy;
- 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;
- Administration of oxandrolone or another anabolic agent (not including testosterone replacement therapy) within the past 6 months;
- A known hypersensitivity to anabolic steroid medications (specifically oxandrolone);
- Coronary athersclerosis with unstable angina pectoris or a history within the past 3 months of an acute myocardial event or decompensated congestive heart failure.
- Inability or unwillingness of the subject or surrogate to provide informed consent.
- TREATMENT PHASE:
- TPU \>200 cm2 surface area of the pelvic region
- 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;
- Patient had flap surgery of the TPU during the Screening Phase;
- Multiple full-thickness pressure ulcers that have a body surface area totaling \>500cm2;
- Clinical and/or laboratory evidence suggestive of prostate cancer;
- Elevated liver function tests (AST \>112 IU/L or bilirubin \>3mg/dl);
- Diabetes mellitus with less than optimal glycemic control (HbA1c \>8.0%);
- 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;
- Initiating or continuing therapy with appetite stimulants (e.g., Megase);
- Current pharmacological therapy for hepatitis B or C infection;
- Pregnancy or lactating female;
- 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;
- Expected use of oral anticoagulants (e.g. warfarin sodium) during the treatment phase;
- Hypercalcemia;
- Coronary athersclerosis with unstable angina pectoris or a history within the past 3 months of an acute myocardial event or decompensated congestive heart failure;
- Participation in another active treatment clinical trial;
- Inability or unwillingness of the subject or surrogate to provide informed consent.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT00101361
Start Date
August 1 2005
End Date
December 1 2008
Last Update
December 20 2013
Active Locations (16)
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1
VA Medical Center, Long Beach
Long Beach, California, United States, 90822
2
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
3
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
4
VA Medical Center, Miami
Miami, Florida, United States, 33125