OBJECTIVE: To determine the safety, tolerability, and efficacy of TGF-beta3 in the treatment of chronic, nonhealing pressure ulcers. DESIGN: A subset analysis of data from a randomized, blind, parallel, placebo-controlled trial involving 270 patients. SETTING: University of Michigan Wound Care Center. PATIENTS: A total of 14 patients (6 women and 8 men aged > or = 18 years) with pressure ulcers were randomly assigned to 1 of 3 groups to receive once daily topical application of recombinant TGF-beta3 or placebo gel for a period of no more than 16 weeks. Group 1 (n=4) received 1.0 microg/cm2 of TGF-beta3, Group 2 (n=5) received 2.5 microg/cm2 of TGF-beta3, and Group 3 (n=5) received placebo gel. All subjects received standardized wound care as well. Weekly evaluations were performed for efficacy, determined by relative wound surface areas and volumes, and were compared with initial baseline values and safety parameters. MAIN OUTCOME MEASURE: Reduction in pressure ulcer area and volume. MAIN RESULTS: Group 2 had a significantly increased rate of wound healing at the fourth visit (P<.05). No significant difference was observed in the healing rate among the groups at the termination of the study. Treatment with TGF-beta3 was well tolerated and there were no significant adverse reactions. CONCLUSION: The findings of this study indicate that the topical application of TGF-beta3 is safe and useful in the treatment of pressure ulcers and is most effective at the earliest stages of therapy.
RCT Entities:
OBJECTIVE: To determine the safety, tolerability, and efficacy of TGF-beta3 in the treatment of chronic, nonhealing pressure ulcers. DESIGN: A subset analysis of data from a randomized, blind, parallel, placebo-controlled trial involving 270 patients. SETTING: University of Michigan Wound Care Center. PATIENTS: A total of 14 patients (6 women and 8 men aged > or = 18 years) with pressure ulcers were randomly assigned to 1 of 3 groups to receive once daily topical application of recombinant TGF-beta3 or placebo gel for a period of no more than 16 weeks. Group 1 (n=4) received 1.0 microg/cm2 of TGF-beta3, Group 2 (n=5) received 2.5 microg/cm2 of TGF-beta3, and Group 3 (n=5) received placebo gel. All subjects received standardized wound care as well. Weekly evaluations were performed for efficacy, determined by relative wound surface areas and volumes, and were compared with initial baseline values and safety parameters. MAIN OUTCOME MEASURE: Reduction in pressure ulcer area and volume. MAIN RESULTS: Group 2 had a significantly increased rate of wound healing at the fourth visit (P<.05). No significant difference was observed in the healing rate among the groups at the termination of the study. Treatment with TGF-beta3 was well tolerated and there were no significant adverse reactions. CONCLUSION: The findings of this study indicate that the topical application of TGF-beta3 is safe and useful in the treatment of pressure ulcers and is most effective at the earliest stages of therapy.
Authors: Zee Upton; Hilary J Wallace; Gary K Shooter; Derek R van Lonkhuyzen; Sim Yeoh-Ellerton; Erin A Rayment; Jacqui M Fleming; Daniel Broszczak; Douglas Queen; R Gary Sibbald; David I Leavesley; Michael C Stacey Journal: Int Wound J Date: 2011-10 Impact factor: 3.315