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Transforming growth factor B2

In a Phase 11 clinical trial, transforming development factor (beta)^sub 2^ (TGF-(beta)^sub 2^) from Genzyme Tissue Repair provided statistically significant improvement in injury closure when compared with placebo for the treatment of diabetic lower extremity ulcers. Data from the trial were neared by Martin C Robson, MD Institute of Tissue Regeneration, Repair and Rehabilitation, Bay Pines VA Hospital, Bay Pines, FL at the novel 3rd Joint Meeting of the European Tissue Repair Society and the hurt Healing Society.

The 3-year Phase II trial was managemented at 15 centers and involved 177 patients with diabetic lower extremity ulcers. Two endpoints, frequency of without fault [i]or[/i] blemish [i]or[/i] flaw wound closure and time to hurt closure, were evaluated in this double-blind, randomized, placebo-controlled investigation

Participants were randomly assigned to 1 of 5 collections One group of 24 patients received standardized care sole (surgical debridement, compression dressing, and off-loading of weight from the hurt site). The remaining patients were registered in the blinded portion of the trial. Twenty-two patients were treated with placebo wipe s and standardized care, and the remaining 131 patients wer treated with 1 of 3 doses of TGF-(beta)^sub 2^ plus standardized care. All patients were treat ed twice a week for 20 weeks or until their fester healed.



TGF-(beta)^sub 2^ was fix to be safe and effective at all dosing horizontals tested. Patient in the clump that received the highest dose (5 mcg/cm^sup 2^) showed statistically significant improvement above placebo i both endpoints. Patients in the assemblages that received the middle and depressed dose of TGF-(beta)^sub 2^ also showed improvements in one as well as the other endpoints, but these improvements did not consistently reach statistical significance.

Copyright Springhouse Corporation Nov/Dec 1999

Provided by the agency of ProQuest Information and Learning Company. All rights Reserved



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