- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00101361
Oxandrolone to Heal Pressure Ulcers
CSP #535 - Anabolic Steroid Therapy on Pressure Ulcer Healing in Persons With Spinal Cord Injury
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Subjects 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.
Criteria 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.
September 2006 - year one report submitted and approved by Central Office. Plan to add up to 3 more sites in the next year.
January 2007 - site #16 (San Antonio) is approved by Veterans Affairs Cooperative Studies Program Central Office to be invited.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 00921
- VA Medical Center, San Juan
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California
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Long Beach, California, United States, 90822
- VA Medical Center, Long Beach
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Palo Alto, California, United States, 94304-1290
- VA Palo Alto Health Care System
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San Diego, California, United States, 92161
- VA San Diego Healthcare System, San Diego
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Florida
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Miami, Florida, United States, 33125
- VA Medical Center, Miami
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Tampa, Florida, United States, 33612
- James A. Haley Veterans Hospital, Tampa
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Georgia
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Augusta, Georgia, United States, 30904
- VA Medical Center, Augusta
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Illinois
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Hines, Illinois, United States, 60141-5000
- Edward Hines, Jr. VA Hospital
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Massachusetts
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Brockton, Massachusetts, United States, 02301
- VA Boston Healthcare System, Brockton Campus
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Missouri
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St Louis, Missouri, United States, 63106
- VA Medical Center, St Louis
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New York
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Bronx, New York, United States, 10468
- VA Medical Center, Bronx
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Ohio
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Cleveland, Ohio, United States, 44106
- VA Medical Center, Cleveland
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Texas
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Dallas, Texas, United States, 75216
- VA North Texas Health Care System, Dallas
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Houston, Texas, United States, 77030
- Michael E. DeBakey VA Medical Center (152)
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Virginia
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Richmond, Virginia, United States, 23249
- Hunter Holmes McGuire VA Medical Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53295-1000
- Zablocki VA Medical Center, Milwaukee
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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 Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: 2
placebo
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Patients will receive an identically appearing placebo capsule until full healing occurs or for 24 weeks, which ever comes first.
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Active Comparator: 1
oxandrolone
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Patients will receive oxandrolone (10mg BID) until full healing occurs or for 24 weeks, which ever comes first.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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A Healed Pressure Ulcer
Time Frame: healing was measured from randomization to full healing or 24 weeks, whichever occured first.
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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.
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healing was measured from randomization to full healing or 24 weeks, whichever occured first.
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Collaborators and Investigators
Investigators
- Study Chair: William Bauman, MD, VA Medical Center, Bronx
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 535
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University of Southern CaliforniaActive, not recruiting
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