Four years ago, we published a 2-part editorial describing the use of an anabolic steroid as part of the treatment plan for a patient with a chronic wound.1,2 The patient, a tetraplegic, had a persistent pressure ulcer that had not healed for over 2 years prior to treatment with the anabolic steroid. A year later,3 we revisited the patient, whose wound remained healed.
Some time after the initial editorial was published, William A. Bauman, MD, and Ann M. Spungen, EdD, members of the Advances in Skin & Wound Care editorial advisory board, approached me about joining a planning board to create a large-scale study to determine the efficacy and safety of an anabolic steroid in spinal cord-injured patients who were being treated for pressure ulcers at Veterans Affairs Medical Centers (VAMCs). I agreed to be part of the process, and I am proud to announce that after years of diligent work, Drs Bauman and Spungen have been awarded a $12 million grant from the VA's Cooperative Studies Program (CSP) of the Health Sciences Research & Development Service to investigate the use of anabolic steroid therapy to improve the healing of pressure ulcers in patients with a spinal cord injury (SCI).
Dr Bauman is the Director and Dr Spungen is the Associate Director of the VA's Rehabilitation Research & Development (RR&D) Service Center of Excellence for the Medical Consequences of Spinal Cord Injury, as well as of the Spinal Cord Damage Research Center (SCDRC). The SCDRC was established at the Bronx VAMC, Bronx, NY, in 1989 by funds provided by United Spinal Association. The 5-year, multi-center grant from the CSP is the largest award ever made to the Bronx research center, and it marks the first collaborative effort between VA's CSP and the RR&D Services. It also represents the first large-scale utilization of the VA's vast clinical research services.
Drs Bauman and Spungen have contributed substantially to our knowledge of cardiovascular disease, pulmonary dysfunction,4 gastrointestinal disorders, endocrinology and metabolism, energy requirements, body composition, and autonomic nervous system dysfunction in persons with an SCI. Through this significant milestone in the history of wound care research, they will no doubt substantially contribute to the health and the quality of life for our veterans and add new knowledge to our field.
The Road to the Grant
The preliminary work that led to this large grant was a small, therapeutic trial in 2000 that provided pilot data for their hypothesis.5 Eight of the 9 patients selected for the trial had nonhealing pressure ulcers of 2 months to 5 years in duration. The patients were treated from 1 to 12 months with oxandrolone, an anabolic steroid, and 8 of the 9 patients completely healed: 3 patients after 3 months, 2 patients after 4 months, 1 patient after 6 months, and 2 patients after 12 months. Although the trial was not a rigorously controlled clinical investigation, the results were surprisingly positive and extremely encouraging.
In February 2001, Drs Bauman and Spungen sent a Letter of Intent to the CPS in Washington, DC, proposing a multi-center, controlled clinical investigation. The Cooperative Studies Scientific Merit Review Board rated the proposal highly in 2002, but requested that a feasibility study be conducted to resolve several concerns. The CSP agreed to fund this feasibility study for approximately $1.5 million for 1 year. After a highly successful feasibility study, which was presented to the director of the CSP in September 2004, the 5-year study was approved in full in January 2005.
The study, entitled "Anabolic Steroid Therapy on Pressure Ulcer Healing in Persons with Spinal Cord Injury" (CSP #535), will take place at 14 VAMCs across the nation. Dr Spungen said that she and Dr Bauman hope to enroll an average of 8 patients per year for each site over the 5-year study period, recruiting a total of 400 participants. The 14 participating VAMCs are in Augusta, GA; Bronx, NY; Cleveland, OH; Dallas, TX; Hines, IL; Houston, TX; Long Beach, CA; Milwaukee, WI; Palo Alto, CA; Richmond, VA; St Louis, MO; San Juan, Puerto Rico; Tampa, FL; and West Roxbury, MA.
Candidates will be selected from among the existing inpatient population at each VAMC site. Prospective participants must have a Stage III or a Stage IV pressure ulcer in the pelvic region. At each study site, patients will receive the "usual standards of care" and any adjunctive therapy that may be of potential use to reduce the size of the ulcer. If the ulcer has not been reduced by at least 15% after 28 days, the patient will be eligible to join the treatment phase of the study. Patients selected for the treatment phase will receive 20 mg of oxandrolone or a placebo daily and the "usual standards of care" for 24 weeks or until complete healing of the ulcer is achieved, whichever comes first.
Dr Spungen said that a completely healed wound-that is, full closure of the wound that stays closed for at least 96 hours-is the primary outcome researchers will be looking for. Additional goals of the study include (1) proving the efficacy of oxandrolone in helping to heal pressure ulcers; (2) obtaining more information about the rate of pressure ulcer healing and the nutritional, inflammatory, and endocrine variables of pressure ulcers and their impact on healing; and (3) an economic analysis to determine the cost of care for treating pressure ulcers, focusing on whether treatment costs can be reduced with the use of an anabolic steroid agent.
I congratulate Drs Bauman and Spungen on their persistence in pursuing the grant for an important study that may help all of us improve outcomes for our patients with nonhealing wounds. I look forward to reporting their results in the years to come.
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