PMID- 9589248
OWN - NLM
STAT- MEDLINE
DCOM- 19980717
LR  - 20220408
IS  - 0149-5992 (Print)
IS  - 0149-5992 (Linking)
VI  - 21
IP  - 5
DP  - 1998 May
TI  - Efficacy and safety of a topical gel formulation of recombinant human 
      platelet-derived growth factor-BB (becaplermin) in patients with chronic 
      neuropathic diabetic ulcers. A phase III randomized placebo-controlled 
      double-blind study.
PG  - 822-7
AB  - OBJECTIVE: To compare the efficacy and safety of topically applied recombinant 
      human platelet-derived growth factor-BB (rhPDGF-BB) (becaplermin) with placebo 
      gel in patients with chronic diabetic neuropathic ulcers of the lower 
      extremities. RESEARCH DESIGN AND METHODS: This multicenter double-blind 
      placebo-controlled phase III trial included 382 patients with type 1 or type 2 
      diabetes and chronic ulcers of at least 8 weeks' duration. After sharp 
      debridement of the ulcer, patients were randomized to receive becaplermin gel 30 
      micrograms/g, becaplermin gel 100 micrograms/g, or placebo gel, in conjunction 
      with a standardized regimen of good wound care until complete wound closure was 
      achieved or for a maximum of 20 weeks. Moist saline-soaked gauze dressings were 
      changed twice daily with study medication applied by patients or caregivers at 
      the evening dressing change. Safety was assessed by monitoring adverse events 
      (AEs) and by clinical laboratory evaluations. RESULTS: Compared with placebo gel, 
      becaplermin gel 100 micrograms/g significantly increased the incidence of 
      complete wound closure by 43% (50 vs. 35%, P = 0.007) and decreased the time to 
      achieve complete wound closure by 32% (86 vs. 127 days; estimated 35th 
      percentile, P = 0.013). AEs reported during treatment or during a 3-month 
      follow-up period were similar in nature and incidence across all treatment 
      groups. CONCLUSIONS: Becaplermin gel 100 micrograms/g, in conjunction with good 
      wound care, significantly increased the incidence of complete wound closure and 
      significantly reduced the time to complete closure of chronic diabetic 
      neuropathic ulcers. The safety profile of becaplermin gel was similar to that of 
      placebo gel.
FAU - Wieman, T J
AU  - Wieman TJ
AD  - Department of Surgery, University of Louisville School of Medicine, Kentucky, 
      USA.
FAU - Smiell, J M
AU  - Smiell JM
FAU - Su, Y
AU  - Su Y
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Diabetes Care
JT  - Diabetes care
JID - 7805975
RN  - 0 (Anticoagulants)
RN  - 0 (Gels)
RN  - 0 (Platelet-Derived Growth Factor)
RN  - 0 (Proto-Oncogene Proteins c-sis)
RN  - 0 (Recombinant Proteins)
RN  - 1B56C968OA (Becaplermin)
SB  - IM
MH  - Administration, Topical
MH  - Aged
MH  - Anticoagulants/adverse effects/*therapeutic use
MH  - Becaplermin
MH  - Chronic Disease
MH  - Demography
MH  - Diabetes Mellitus, Type 1/complications
MH  - Diabetes Mellitus, Type 2/complications
MH  - Diabetic Foot/*drug therapy/etiology
MH  - Double-Blind Method
MH  - Drug Evaluation
MH  - Female
MH  - Gels
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Platelet-Derived Growth Factor/adverse effects/*therapeutic use
MH  - Proto-Oncogene Proteins c-sis
MH  - Recombinant Proteins/adverse effects/therapeutic use
MH  - Reference Values
MH  - Treatment Outcome
EDAT- 1998/05/20 00:00
MHDA- 1998/05/20 00:01
CRDT- 1998/05/20 00:00
PHST- 1998/05/20 00:00 [pubmed]
PHST- 1998/05/20 00:01 [medline]
PHST- 1998/05/20 00:00 [entrez]
AID - 10.2337/diacare.21.5.822 [doi]
PST - ppublish
SO  - Diabetes Care. 1998 May;21(5):822-7. doi: 10.2337/diacare.21.5.822.