1. Hess, Cathy Thomas BSN, RN, CWOCN, Department Editor

Article Content

Foot Ulcers

Cytomedix, Inc, Little Rock, AR, has received Food and Drug Administration (FDA) approval to initiate clinical trials for its AutoloGel System for the treatment of chronic diabetic foot ulcers. The randomized, double-blinded, controlled study against the standard of care for the treatment of chronic wounds will be conducted at as many as 12 sites throughout the United States; enrollment of approximately 74 patients was expected to begin in mid-April. The AutoloGel System involves the production of a treating composition that delivers multiple growth factors to the affected wound bed.


Vascular Sealant

CLOSURE Medical (Raleigh, NC) has received approval from the FDA to initiate a clinical study to support US pre-market approval for its vascular sealant product, the company's first product to be used inside the body. The approval was based on the positive results of a 10-patient pilot study that completed enrollment last December.


The randomized study will enroll 150 patients, with 4-and 12-week follow-up visits, at approximately 14 medical institutions in the U.S. and Europe. Dr Alan B. Lumsden of Baylor College of Medicine and the Methodist DeBakey Heart Center, The Methodist Hospital, Houston, TX, will act as the principal investigator of the study, which will assess the ability of CLOSURE's vascular sealant to prevent leakage following reconstruction of vascular structures in patients receiving femoral-popliteal bypass or arteriovenous access grafting.