TGF-beta3 in the treatment of pressure ulcers: a preliminary report.
OBJECTIVE
To determine the safety, tolerability, and efficacy of TGF-beta3 in the treatment of chronic, nonhealing pressure ulcers.


METHODS
A subset analysis of data from a randomized, blind, parallel, placebo-controlled trial involving 270 patients.


METHODS
University of Michigan Wound Care Center.


METHODS
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.


METHODS
Reduction in pressure ulcer area and volume.


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.


CONCLUSIONS
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.
Hirshberg
J
J
University of Michigan, Ann Arbor, USA.
Coleman
J
J
Marchant
B
B
Rees
R S
RS
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D003668:Pressure Ulcer / Q000175:diagnosis / Q000188:drug therapy*; D012016:Reference Values; D012720:Severity of Illness Index; D016212:Transforming Growth Factor beta / Q000008:administration & dosage*; D053782:Transforming Growth Factor beta3; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects
D016212:Transforming Growth Factor beta; D053782:Transforming Growth Factor beta3