Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT00101361
Status:
TERMINATED
Last Update Posted:
2013-12-20
First Post:
2005-01-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oxandrolone to Heal Pressure Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010074', 'term': 'Oxandrolone'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'william.bauman@va.gov', 'phone': '718-584-9000', 'title': 'William A. Bauman, M.D.', 'organization': 'James J. Peters VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Selection of severe wounds may have reduced treatment response. The study was terminated after a futility analysis showed a low probability of detecting a significant difference between groups.'}}, 'adverseEventsModule': {'timeFrame': 'years, 5 months', 'description': 'Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.', 'eventGroups': [{'id': 'EG000', 'title': '1 Oxandrolone', 'description': 'oxandrolone - two 5mg capsules twice daily', 'otherNumAtRisk': 108, 'otherNumAffected': 95, 'seriousNumAtRisk': 108, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': '2 Placebo', 'description': 'placebo - two capsules twice daily', 'otherNumAtRisk': 104, 'otherNumAffected': 85, 'seriousNumAtRisk': 104, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'constipation or diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'elevated liver enzyme levels', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'infection', 'notes': 'cellulitis, sepsis, clostridial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'nausea / vomitting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'non-Target Pressure Ulcer (TPU) skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'osteomylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'skin rash / complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 28, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}], 'seriousEvents': [{'term': 'oral cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'small bowel obstruction, renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'elective bladder stone removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'myocutaneous flap surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}, {'term': 'death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 13'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'A Healed Pressure Ulcer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Oxandrolone', 'description': 'oxandrolone - two 5mg capsules twice daily'}, {'id': 'OG001', 'title': '2 Placebo', 'description': 'placebo - two capsules twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.7', 'ciLowerLimit': '-17.5', 'ciUpperLimit': '6.8', 'groupDescription': 'For spinal cord injury patients with a Stage III or IV pressure ulcer of the pelvic region who receive 24 weeks or less of optimized clinical care (i.e., guideline-driven care with nutritional support) compared with optimized clinical care and an oral anabolic steroid agent (oxandrolone) there will be no difference in the percent of healed pressure ulcers.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'the required sample size of 400 participants provided 85% power to detect an increase in healing from 25% in the placebo group to 40% in the oxandrolone group, as assuming a 0.05 (2-sided) type I error, 13% rate of loss to follow up, and a test of proportions by using an arcsine transformation.'}], 'paramType': 'NUMBER', 'timeFrame': 'healing was measured from randomization to full healing or 24 weeks, whichever occured first.', 'description': 'Patients remained in treatment until full healing of the target pressure ulcer (defined as re-epithelialization to a cicatrix with a dry surface and zero open area for a minimum of 96 hours) or 24 weeks, whichever occured first.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 Oxandrolone', 'description': 'oxandrolone - two 5mg capsules twice daily'}, {'id': 'FG001', 'title': '2 Placebo', 'description': 'placebo - two capsules twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'enrollment started 08/01/2005 and ended 10/10/2008 at 15 VA Medical Centers. Subjects were randomized only after a four week screening phase.', 'preAssignmentDetails': 'Potential participants were screened for four weeks to determine eligibility based on documentation of a difficult-to-heal or worsening status of the pressure ulcer as an inpatient.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxandrolone', 'description': 'Oxandrolone'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.4', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '57.3', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '57.9', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'overall baseline participants were determined by number of participants that were eligible after screening based on a pressure ulcer that is defined as hard-to-heal or worsening at randomization.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'whyStopped': 'futility analysis showed low probability of detecting a significant difference', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-26', 'studyFirstSubmitDate': '2005-01-07', 'resultsFirstSubmitDate': '2013-06-27', 'studyFirstSubmitQcDate': '2005-01-07', 'lastUpdatePostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-23', 'studyFirstPostDateStruct': {'date': '2005-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A Healed Pressure Ulcer', 'timeFrame': 'healing was measured from randomization to full healing or 24 weeks, whichever occured first.', 'description': 'Patients remained in treatment until full healing of the target pressure ulcer (defined as re-epithelialization to a cicatrix with a dry surface and zero open area for a minimum of 96 hours) or 24 weeks, whichever occured first.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dermatologic', 'skin', 'clinical trial', 'androgen/anabolic'], 'conditions': ['Pressure Ulcer']}, 'referencesModule': {'references': [{'pmid': '23689765', 'type': 'DERIVED', 'citation': 'Bauman WA, Spungen AM, Collins JF, Raisch DW, Ho C, Deitrick GA, Nemchausky BA, Goetz LL, Park JS, Schwartz M, Merritt JL, Jayawardena V, Sandford P, Sabharwal S, Holmes SA, Nasar F, Sasaki R, Punj V, Zachow KF, Chua WC, Thomas MD, Trincher RC. The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury: a randomized trial. Ann Intern Med. 2013 May 21;158(10):718-26. doi: 10.7326/0003-4819-158-10-201305210-00006.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 oral anabolic steroid agent (oxandrolone) will have a greater percent of healed pressure ulcers than those who receive placebo and the same optimized clinical care. The major secondary objective is to determine whether the healed pressure ulcer will remain healed for at least 8 weeks.\n\nSubjects are registered into a 4 week screening phase to be followed with weekly photos of the ulcer and if healed less than 30% (from the day 1 photo to the day 28 photo) with standard clinical care, they are introduced to the treatment phase (randomized) and followed for another 24 weeks on either oxandrolone or placebo. Wounds that heal (remain closed for at least 96 hours) are then subject to 2 four week follow up visits.\n\nCriteria for entering the screening phase are simple: either gender, age 18 years or older, inpatient with SCI or equivalent spinal cord damage and at least 1 Stage III or IV (indicating a severe wound, \\<260cm2) pressure ulcer of the pelvic region.\n\nSeptember 2006 - year one report submitted and approved by Central Office. Plan to add up to 3 more sites in the next year.\n\nJanuary 2007 - site #16 (San Antonio) is approved by Veterans Affairs Cooperative Studies Program Central Office to be invited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSCREENING PHASE:\n\n1. Male or female inpatient with SCI or equivalent spinal cord damage.\n2. At least one Stage III or IV (including a severe wound, \\<260cm2) pressure ulcer of the pelvic region.\n\nTREATMENT PHASE:\n\n1\\. 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)\n\nExclusion Criteria:\n\nSCREENING PHASE:\n\n1. Persons who are candidates for and elect to have reconstructive flap surgery of the TPU;\n2. 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.\n3. 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;\n4. Previously diagnosed active malignant disease;\n5. 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);\n6. Radiation therapy in the pressure ulcer field at anytime during the patient's lifetime;\n7. Life expectancy less than 12 months;\n8. Nephrosis, hemodialysis or chronic ambulatory peritoneal dialysis therapy;\n9. 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;\n10. Administration of oxandrolone or another anabolic agent (not including testosterone replacement therapy) within the past 6 months;\n11. A known hypersensitivity to anabolic steroid medications (specifically oxandrolone);\n12. Coronary athersclerosis with unstable angina pectoris or a history within the past 3 months of an acute myocardial event or decompensated congestive heart failure.\n13. Inability or unwillingness of the subject or surrogate to provide informed consent.\n\nTREATMENT PHASE:\n\n1. TPU \\>200 cm2 surface area of the pelvic region\n2. 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;\n3. Patient had flap surgery of the TPU during the Screening Phase;\n4. Multiple full-thickness pressure ulcers that have a body surface area totaling \\>500cm2;\n5. Clinical and/or laboratory evidence suggestive of prostate cancer;\n6. Elevated liver function tests (AST \\>112 IU/L or bilirubin \\>3mg/dl);\n7. Diabetes mellitus with less than optimal glycemic control (HbA1c \\>8.0%);\n8. 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;\n9. Initiating or continuing therapy with appetite stimulants (e.g., Megase);\n10. Current pharmacological therapy for hepatitis B or C infection;\n11. Pregnancy or lactating female;\n12. 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;\n13. Expected use of oral anticoagulants (e.g. warfarin sodium) during the treatment phase;\n14. Hypercalcemia;\n15. Coronary athersclerosis with unstable angina pectoris or a history within the past 3 months of an acute myocardial event or decompensated congestive heart failure;\n16. Participation in another active treatment clinical trial;\n17. Inability or unwillingness of the subject or surrogate to provide informed consent."}, 'identificationModule': {'nctId': 'NCT00101361', 'briefTitle': 'Oxandrolone to Heal Pressure Ulcers', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'CSP #535 - Anabolic Steroid Therapy on Pressure Ulcer Healing in Persons With Spinal Cord Injury', 'orgStudyIdInfo': {'id': '535'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'oxandrolone', 'interventionNames': ['Drug: Oxandrolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Oxandrolone', 'type': 'DRUG', 'description': 'Patients will receive oxandrolone (10mg BID) until full healing occurs or for 24 weeks, which ever comes first.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will receive an identically appearing placebo capsule until full healing occurs or for 24 weeks, which ever comes first.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VA Medical Center, Long Beach', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '94304-1290', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'VA Medical Center, Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'James A. Haley Veterans Hospital, Tampa', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30904', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'VA Medical Center, Augusta', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60141-5000', 'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hines, Jr. VA Hospital', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}, {'zip': '02301', 'city': 'Brockton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Boston Healthcare System, Brockton Campus', 'geoPoint': {'lat': 42.08343, 'lon': -71.01838}}, {'zip': '63106', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'VA Medical Center, St Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'VA Medical Center, Bronx', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'VA Medical Center, Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'VA North Texas Health Care System, Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. DeBakey VA Medical Center (152)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hunter Holmes McGuire VA Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53295-1000', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Zablocki VA Medical Center, Milwaukee', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '00921', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'VA Medical Center, San Juan', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'William Bauman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'VA Medical Center, Bronx'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}