Venous (stasis) ulceration of the lower extremity is a problem of ever-increasing magnitude in the United States. Most patients are elderly and two thirds are women. Venous ulcers incapacitate the elderly and add to their frailty. An established treatment for venous ulcers is the application of leg compression bandages, such as the Unna boot, which reduce lower extremity venous hypertension by enhancing the action of the calf muscle pump. Recently, it has been proposed that venous hypertension causes the formation of pericapillary fibrin cuffs, which result in ulceration by interfering with the proper exchange of oxygen and other nutrients between blood and dermis. More recent evidence suggests that fibrin may bind to or render unavailable specific growth-regulatory peptides. The pathogenic role of fibrin is still not clear, but the presence of tissue hypoxia, profound alterations of systemic fibrinolysis, and dermal pericapillary fibrin cuffs in patients with venous ulcers are well established. Stanozolol, an anabolic steroid with fibrinolytic properties, has been reported to improve venous disease and ulcers caused by intravascular fibrin deposition. By increasing muscle mass, stanozolol also has the potential to improve lower extremity strength and the function of the calf muscle pump. The hypothesis of this proposal is that stanozolol can improve venous disease and frailty in elderly patients due to its positive effects on both muscle strength and fibrin degradation. We propose a randomized, double-blind, 24-week trial of orally administered stanozolol vs placebo in elderly patients with venous ulcers. The primary objective will be to determine the therapeutic effect and safety of stanozolol in ulcer healing. We will also investigate the effects of stanozolol on lower extremity muscle strength, calf muscle pump action, and somatomedin levels. The fibrinolytic action of stanozolol will be assessed by measurements of fibrinogen, D-dimer, and tissue plasminogen activator. It is hoped that these studies will establish stanozolol as an effective and rational treatment for ulcer healing and physical frailty in elderly patients with venous ulcers.

National Institute of Health (NIH)
National Institute on Aging (NIA)
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Biological and Clinical Aging Review Committee (BCA)
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University of Miami School of Medicine
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