by Michelle Pierre, MA, RD
Note: This article features a VA Cooperative Study entitled, “Anabolic Steroid Therapy on Pressure Ulcer Healing in Persons with Spinal Cord Injury.” This work is being supported by the Spinal Cord Damage Research Center (SCDRC) at the Bronx Department of Veterans Affairs Medical Center (VAMC).
The mission of the VA Cooperative Studies Program is to improve the health and care of veterans through collaborative research studies that produce innovative and effective solutions to national health care problems. As part of this program, Dr. William A. Bauman, Director of the SCDRC, initiated a research proposal to determine the effect of an anabolic steroid agent, oxandrolone, on pressure ulcer healing in persons with spinal cord injury (SCI). This multi-center study re p resents the first collaboration between two VA research services, the Cooperative Studies Program and Rehabilitation Research and Development Service, as well as the first cooperative study involving the SCI services.
Pressure ulcers, as the name implies, result from skin breakdown on areas of the body, most often in the pelvic region, that are subjected to prolonged periods of increased pressure in immobilized persons, such as those with SCI. According to data from Veterans Health Administration researchers, approximately 28% of the veteran population with SCI have pressure ulcers, with about 15% of persons with SCI developing a more serious wound requiring hospitalization during their lifetime.
The progression of pressure ulcers is measured in four stages: Stage I is characterized by observable alterations in intact skin that may also include changes in temperature, consistency or sensation resulting from prolonged pressure; Stage II, by upper level or epidermis skin loss; Stage III, by skin loss involving damage to the underlying tissues, but not including deeper tissue damage; and Stage IV, by skin loss with extensive damage to muscle or bone. Patients with Stage III and IV pressure ulcers are at risk for loss of body weight and muscle mass, which, in turn, can increase the risk for infection and impair wound healing. A systemic infection in a patient with SCI can be serious, especially if the person has other medical problems, such as poor nutrition, anemia, cardiovascular disease, or diabetes. The stress of a severe pressure ulcer may trigger a response in the body to decrease immunity and reduce anabolic or “muscle-building” hormones.
What can we do to help heal these chronic, debilitating wounds? From preliminary studies, it appears that there is a role for anabolic steroid agents in the care of patients with pressure ulcers.
Anabolic steroids have a controversial reputation as performance-enhancing drugs that are sometimes abused by athletes and may lead to serious medical consequences. In the treatment of various medical conditions, however, they can help patients regain weight that they have lost due to illness. Oxandrolone is a potent anabolic steroid agent that has been reported in collections of individual studies to heal intractable pressure ulcers in persons with SCI.
The primary objective of this study is to determine whether hospitalized patients with SCI and chronic severe pressure ulcers have a greater percentage of healing with standard clinical wound care and oxandrolone than those who receive standard clinical wound care without oxandrolone. A second objective is to determine whether the healed pressure ulcer remains closed after healing for eight weeks.
A one-year Feasibility Study was approved in June 2003 by the Cooperative Studies P rogram. The Bronx VAMC is a Full Study site for this investigation, and this facility is also the Chairman’s Office for the study. If the Feasibility Study shows that there are enough eligible patients to enroll in this protocol, then a five-year prospective clinical trial will be implemented. The Feasibility Study includes study sites that are performing the Full Study ( Screening Phase and Treatment Phase) and the Screening Phase only.
Eligibility for the Screening Phase includes: male or female SCI service inpatients, 18 years of age or older with a Stage III or IV pressure ulcer of the pelvic region. The Screening Phase consists of four weeks. The target pressure ulcer is measured weekly using a digital software program. A history and physical exam, routine laboratory tests, nutritional intake, mood and cognitive assessments plus a questionnaire that assesses quality of life and cost of care is also being performed.
By the end of the four weeks of the Screening Phase, if the subject does not experience more than 15% healing of the target pressure ulcer, they may be eligible for the Treatment Phase, in which they would be randomized to receive the usual standard of clinical care for pressure ulcer healing with either oxandrolone or a placebo “sugar pill.” The Treatment Phase continues until healing or 24 weeks, whichever comes first. An eight-week Follow-up Phase will also be performed after healing to determine if the pressure ulcer has remained closed. Digital wound measurements, laboratory and nutritional evaluations, mood and cognitive assessments, and a quality of life/cost of care questionnaire will be obtained. Additionally, a weekly measurement of the body’s energy needs and a determination of whether the patient’s nutritional intake is adequate to meet his/her nutritional requirements will be performed.
In addition to the Bronx VA facility, VAMCs in Richmond, Virginia, and Dallas, Texas, are participating in the Full Study. The other 11 sites that are participating in the Screening Phase only are Augusta, Georgia; West Roxbury, Massachusetts; Cleveland, Ohio; Hines VAMC in Chicago; Houston, Texas; Long Beach and Palo Alto in California; St. Louis, Missouri; San Juan, Puerto Rico; Tampa, Florida; and Milwaukee, Wisconsin.
Dr. George A. Deitrick is the Principal Investigator for this study at the Bronx VAMC and I am the Research Coordinator. In the Bronx, nine patients have been screened for this study and two have been enrolled in the Treatment Phase.
For further information about this study, please contact me in the SCDRC at 718-584-9000, extension 5419.
Michelle Pierre, MA, RD, is a Research Health Science Specialist at the Bronx VAMC Spinal Cord Damage Research Center.
