by Michelle Pierre, MA, RD
A little more than a year ago, Orbit published an article describing a feasibility study to investigate pressure ulcer healing in persons with spinal cord injury (SCI) “Can Anabolic Steroids Heal Pressure Ulcers?, September 2004″.
The 1-year multi-center feasibility study was successfully completed, and in January 2005, the VA Cooperative Studies Program approved and funded a study entitled “A VA Cooperative Study, Anabolic Steroid Therapy on Pressure Ulcer Healing in Persons with Spinal Cord Injury.” (Orbit, April ’05)
The mission of the VA Cooperative Studies Program is to advance the health and care of veterans through collaborative research studies that produce innovative and effective solutions to national health care problems. This 5-year prospective clinical trial tests the ability of oxandrolone, an oral anabolic steroid medication, to treat difficult-to-heal pressure ulcers. It includes 14 VA Medical Center sites: Augusta, Bronx, Cleveland, Dallas, Hines, Houston, Long Beach, Miami, Milwaukee, Palo Alto, Richmond, St. Louis, San Juan, and Tampa.
Dr. William A. Bauman and Dr. Ann M. Spungen of the James J. Peters VAMC in the Bronx, New York co-chair the study. This is the first study to combine the resources of the VA’s Cooperative Studies Program with the Rehabilitation Research & Development Service, as well as the first cooperative study to involve the VA’s SCI Services.
Background
Pressure ulcers result from skin breakdown on areas of the body that are subjected to prolonged periods of increased pressure, which commonly occurs in those with SCI. The vast majority of pressure ulcers in persons with SCI occur in the pelvic region.
From preliminary studies, it appears that there is a role for anabolic steroid agents in the care for patients with pressure ulcers, but this needs to be proven. The primary objective of this study is
to determine whether hospitalized patients with SCI with 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. Another objective is to determine whether the healed pressure ulcer remains closed after healing for 8 weeks.
Eligible for the screening phase are male or female SCI Service inpatients, 18 years of age or older, with a full-thickness pressure ulcer of the pelvic region. The screening phase consists of 4 weeks. The target pressure ulcer is measured weekly using a digital software program. If, by the end of the 4 weeks, the subject does not experience more than 30% healing of the target pressure ulcer, they may be eligible for the treatment phase.
In the treatment phase, the subjects will be randomized to receive the usual clinical care for their pressure ulcer with either oxandrolone or a placebo.The treatment phase continues until the wound is healed or for 24 weeks, whichever comes first. Finally comes an 8-week follow-up phase after healing to determine if the pressure ulcer has remained closed.
For further information about this study, please contact the following research coordinators or investigators at your nearest VAMC:
Augusta VAMC, Site Coordinator: Sandy Nalley, 706-733-0188 x1956
James J. Peters VAMC , Site Coordinator: Michael LaFountain, 718-584-9000 x3123
Cleveland VAMC, Site Coordinator: Monique Washington, 216-791-3800 ext. 3874
Dallas VAMC, Site Coordinator: Jackie McFarlin, 214-857-1785
Hines VAMC, Site Coordinator: Nadia Sakla, 708-202-7119
Houston VAMC, Site Coordinator: Colleen Cerra Stewart, 713-794-7127
Long Beach VAMC, Site Investigator: Dr.Walter Chua, 562-826-8000, ext, 4878
Miami VAMC, Site Coordinator: Jacqueline Edelstein, 305-575-7000, ext. 3769
Milwaukee VAMC, Site Coordinator: Joe Berman, 414-384-2000, ext. 4-2408
Palo Alto VAMC, Site Coordinator: Rona Relova, 650-493-5000, ext. 63880
Richmond VAMC, Site Coordinator: Jewel Moore, 804-675-5000, ext. 4303
Saint Louis VAMC, Site Coordinator: Mary Ann Jacobs, 314-894-5727
San Juan VAMC, Site Investigator: Dr. Gloria Rodriguez-Vega, 787-641-7582, ext.11329
Tampa VAMC, Site Coordinator: Theresa Durant, 813-979-7219
Michelle Pierre, MA, RD, the National Research Coordinator for this study, is a researcher at the Spinal Cord Damage Research Center at the James J. Peters VAMC in the Bronx, New York.
