1. Section Editor(s): Hess, Cathy Thomas BSN, RN, CWOCN, Department Editor

Article Content

Diabetic Foot Ulcers

After completing a review of the modified diabetic foot ulcer (DFU) protocol submitted by Ortec International, Inc, New York, NY, the Food and Drug Administration (FDA) has given Ortec permission to initiate a pivotal trial evaluating OrCel in the treatment of DFUs.


The DFU trial is expected to be conducted at up to 25 clinical centers and involve approximately 200 patients. The company expects to begin enrolling patients following approval of its Premarket Approval (PMA) application for the use of OrCel in the treatment of venous leg ulcers. The PMA is currently under review by the FDA.


A recent multicenter, controlled pilot study included patients with hard-to-heal DFUs that were less than or equal to 6 cm in size. Of those treated with OrCel, 47% were completely healed, compared with 23% of patients in the control group.


[black up pointing small triangle] Information:


Venous Ulcers

RegeneRx Biopharmaceuticals, Inc, Bethesda, MD, has announced a second Phase II trial to test its drug, Thymosin beta 4 (T[beta]4), for the treatment of venous ulcers. T[beta]4 is a naturally occurring peptide present in virtually all human cells. It represents a new type of wound-healing drug that promotes endothelial cell differentiation, keratinocyte cell migration, and angiogenesis in and around wounds. It also downregulates a number of inflammatory cytokines and chemokines.


The trial will be a randomized, double-blind, placebo-controlled trial designed to test several dosages of T[beta]4 in patients with venous ulcers in Italy and at least 1 other European country. The drug will be topically administered to each patient over a period of several weeks. Conducted by RegeneRx's European pharmaceutical partner, Sigma-Tau Group, the study is scheduled for the second quarter of 2005, and is expected to be completed and analyzed within a year of enrolling the first patient.


[black up pointing small triangle] Information:


Skin Assessment

A recent survey sponsored by Sage Products, Cary, IL, concluded that a patient's length of stay in the hospital directly affects whether the patient is bathed. At least 30% of the 1000 adults interviewed, who had been hospitalized or had a family member hospitalized for more than a week, said they were not bathed once a day while in the hospital. About a quarter of patients who had a hospital stay of 6 days or less (26%) said they were bathed by hospital staff every other day or once every 3 days. TNS NFO, an independent research firm, conducted the survey.


Bathing patients is not just for cleanliness. It also offers clinicians the opportunity to:


* assess the patient's skin for any signs of breakdown or other new problems


* monitor the patient's skin for breakdown in the perineal area, which can lead to pressure ulcers


* remove bacteria from the skin and reduce the risk for infection


* improve the patient's self-esteem, which can affect the healing process.



[black up pointing small triangle] Information:


New Bandage Technology

The University of Akron, OH, is developing nanofiber bandages that could potentially provide more effective treatment to patients with slow-healing wounds, including US troops serving in Iraq. Phase II clinical trials of the bandages are being conducted in Bucaramanga and Tolima, Colombia, on infections caused by the tropical disease leishmaniasis, a parasitic disease transmitted by the bite of sand flies. The university and the Colombian Cardiovascular Foundation are collaborating on the trials.


The nanofiber technology, patented by University of Akron chemistry professor Dr Daniel Smith and polymer science professor Dr Darrell Reneker, releases nitric oxide in a controlled manner to kill the parasite and reduce inflammation. This allows the healing process to take effect by reestablishing the vascular flow of oxygen to the area.


[black up pointing small triangle] Information: