Efficacy & Safety

Dermagraft

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Complete Wound Closure

Compared with conventional therapy, Dermagraft heals chronic diabetic foot ulcers significantly faster in more patients, and with fewer complications1,2

  • The primary endpoint of complete wound closure by 12 weeks was achieved in 30.0% of Dermagraft treated and 18.3% of control patients2

Patients Healed1,2

Complete Wound Closure

 

  • The Bayesian analysis concluded that the probability that Dermagraft plus conventional therapy increased the chance of achieving wound closure in patients with ulcers greater than 6 weeks duration over and above that of conventional therapy alone was 98.4%1
  • After controlling for ulcer area, Dermagraft-treated patients were 70% more likely to heal at any given time during the study than the control patients2

 

Safety

The overall incidence of adverse events was comparable between both treatment groups1

Adverse Events Reported in ≥5% of Patients Treated with Dermagraft1

Adverse Events Reported

 Patients Experiencing Infection, Osteomyelitis, or Cellulitis Involving the Study Ulcer2

 Patients Experiencing Infection

 

References
  1. Dermagraft [Directions for Use]. La Jolla, CA: Advanced BioHealing; 2007.
  2. Marston WA, Hanft J, Norwood P, et al. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003;26(6):1701-5.