Transforming growth factor B2

Advances in Wound Care, Nov/Dec 1999 by Thomas, Cathy

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

The 3-year Phase II trial was conducted at 15 centers and involved 177 patients with diabetic foot ulcers. Two endpoints, frequency of complete wound closure and time to wound closure, were evaluated in this double-blind, randomized, placebo-controlled study.

Participants were randomly assigned to 1 of 5 groups. One group of 24 patients received standardized care only (surgical debridement, compression dressing, and off-loading of weight from the wound site). The remaining patients were enrolled in the blinded portion of the trial. Twenty-two patients were treated with placebo sponges 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 ulcer healed.

TGF-(beta)^sub 2^ was found to be safe and effective at all dosing levels tested. Patient in the group that received the highest dose (5 mcg/cm^sup 2^) showed statistically significant improvement over placebo i both endpoints. Patients in the groups that received the middle and low dose of TGF-(beta)^sub 2^ also showed improvements in both endpoints, but these improvements did not consistently reach statistical significance.