Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity ulcers.
BACKGROUND
Diabetic foot ulcer is a major health care problem that leads to amputation.


METHODS
Patients with full-thickness diabetic neurotrophic foot ulcers present for longer than 8 weeks without healing were entered into one of five randomized, prospective, blinded clinical trials comparing treatment with platelet-derived growth factor (PDGF) or placebo gel for up to 20 weeks. The purpose of these trials was to assess the safety and efficacy of PDGF used with good wound care. Each patient had an adequate arterial blood supply, was free of infection, was off-loaded, and was extensively débrided. The ulcers had been present for at least 8 weeks.


RESULTS
A total of 922 patients were entered into the study. Analysis of ulcers with a baseline area of less than 10 cm (95 percent of patients) showed that patients treated with PDGF at 100 mug/g had a significant increase in complete healing compared with patients given placebo (50 percent versus 36 percent, p < 0.007). PDGF also decreased the time to complete healing by 30 percent (14 weeks versus 20 weeks, p = 0.01). Adverse events were similar in both treatment groups, as were recurrent ulcer rates.


CONCLUSIONS
PDGF applied once daily was effective in healing chronic diabetic neurotrophic foot ulcers when used in conjunction with good wound care.
Steed
David L
DL
Department of Surgery, University of Pittsburgh, UPMC Presbyterian Hospital, Pittsburgh, Pa 15213, USA. steeddl@hotmail.com
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D043925:Angiogenesis Inducing Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000077214:Becaplermin; D003646:Debridement; D017719:Diabetic Foot / Q000188:drug therapy* / Q000601:surgery; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D010982:Platelet-Derived Growth Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D020574:Proto-Oncogene Proteins c-sis; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000627:therapeutic use; D012039:Regional Blood Flow / Q000187:drug effects; D013997:Time Factors; D014945:Wound Healing / Q000187:drug effects*; D014946:Wound Infection / Q000628:therapy
D043925:Angiogenesis Inducing Agents; D005782:Gels; D010982:Platelet-Derived Growth Factor; D020574:Proto-Oncogene Proteins c-sis; D011994:Recombinant Proteins; D000077214:Becaplermin