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

Collagen-glycosaminoglycan biodegradable matrix (Integra™ Bilayer Matrix Wound Dressing, Integra LifeSciences, Plainsboro, NJ) is a bovine collagen/shark cartilage matrix with a silicone backing that allows the patient to generate a “neo-dermis.” Soon after the success of collagen-glycosaminoglycan biodegradable matrix in treating burn wounds was established, centers familiar with its potential for decreasing scar at donor sites began using it to treat chronic wounds of many different types with good success.^1–3 Many reported wonderful outcomes,^1&ndas

Presentation

A healthy 55-year-old man suffered a superficial skin abrasion to the left medial ankle while working at a sewage treatment plant. The abrasion progressed to a shallow ulcer with surrounding erythema over the next 4 to 5 days. A worsening course over the following 3 weeks prompted referral to the authors’ facility for further evaluation. Initial examination revealed an exquisitely tender, shallow ulcer, measuring approximately 8 cm x 5 cm with a necrotic base and extensive surrounding erythema (Figure 1).

Diagnosis

Culture results from a wound