Cytomedix Announces Favorable Results from Diabetic Foot Ulcer Clinical Trial

       Cytomedix Inc. (Rockville, Md) announces that the audit of its clinical investigational sites and trial results for diabetic foot ulcers is complete. The company began this audit with the assistance of an independent consultant, a former US Food and Drug Administration (FDA) branch chief responsible for bioresearch monitoring.
       During the audit, it was discovered that some investigational centers had enrolled patients who did not meet the inclusion criteria or were not given treatment according to the study protocol. The trial yielded 40 patients after correcting for these types of deviations.
       Of those 40 patients, 35 (88%) had wounds that were less than or equal to 7 cm2 in area and 2 cm3 in volume. The healing rates for these wounds in the AutoloGel™ group and control group were 81.3% and 42.1%, respectively. The control group was treated using an FDA-approved saline gel for use in wound treatment.
       In the overall cohort of 40 patients, 68.4% treated with the AutoloGel healed to full wound closure and 42.9% of patients in the control group achieved full wound closure.
       The healing rate for the AutoloGel group (81.3%) and the overall healing rate (68.4%) are competitive with or better than most other wound care products that are both FDA-approved and covered by Medicare.
       Visit http://www.cytomedix.com or call 240-499-2680 for more information.

RegeneRx Receives First Drug Patent in China

       RegeneRx Biopharmaceuticals Inc. (Bethesda, Md) reports that the company has received notification that the State Intellectual Property Office of the People’s Republic of China (CSIPO) has accepted the company’s first patent application for their Thymosin beta 4 (TB4) wound healing technology platform.
       Visit http://www.regenerx.com or e-mail jjfnk@regenerx.com for more information.

Differences in the Skin Can Help Detect Ulcerative Foot Disease Before it Develops

       Researchers at the Joslin-Beth Israel Deaconess Foot Center and Microcirculation Laboratory (Boston, Mass) found that early changes in the oxygenation of the skin could help foretell the development of ulcerations and enable doctors to treat patients at an earlier stage before the onset of serious complications.
       The authors set out to specifically identify these changes, knowing that changes in large vessels and microcirculation of the diabetic foot play a central role in the development of ulcers and their subsequent failure to heal.
       Using a novel technology known as medical hyperspectral imaging (MHSI), the authors studied a total of 108 patients—21 control subjects who did not have diabetes, 36 patients with diabetes who did not have neuropathy, and 51 patients with both diabetes and neuropathy. They also measured foot muscle energy reserves using a magnetic spectroscopy, a new method based on magnetic resonance imaging (MRI).
       As predicted, their results found measurable differences in the skin of patients with diabetes and, in particular, those with peripheral neuropathy as well. These differences can be detected before ulcerative foot disease develops.
       The results indicate that in the skin of patients with diabetes the amount of available oxygen is reduced and that this impairment is accentuated in the presence of neuropathy. The results also showed that energy reserves of the foot muscles are reduced in the presence of diabetes, suggesting that microcirculatory changes could also play a major role.
       Source: Beth Israel Deaconess Medical Center