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- Title
Integrating the Results of Phase IV (Postmarketing) Clinical Trial With Four Previous Trials Reinforces the Position that Regranex (Becaplermin) Gel 0.01% Is an Effective Adjunct to the Treatment of Diabetic Foot Ulcers.
- Authors
Robson, Martin C.; Payne, Wyatt G.; Garner, Warren L.; Biundo, Joseph; Giacalone, Vincent F.; Cooper, Diane M.; Ouyang, Peter
- Abstract
Background: Platelet-derived growth factor (PDGF) has been demonstrated in pre-clinical studies to promote granulation tissue and stimulate cutaneous ulcer healing. Becaplermin gel 100 µg/g is the commercial preparation of the PDGF-BB homodimer and has been approved by the FDA as Regranex Gel 0.01% for use in diabetic foot ulcers. Materials and Methods: A Phase IV (Postmarketing) investigator-blinded, randomized, parallel group, multicenter trial was performed comparing once daily application of Regranex Gel 0.01% plus standardized wound therapy to standardized therapy alone. Meta-analyses were performed on the results of the Phase IV trial integrated into the pooled results of 4 previous trials using becaplermin gel evaluating incidence of complete healing, time to healing, and relative ulcer size at endpoint. Results: In the Phase IV trial, 42% of the Regranex Gel treatment group healed versus 35% for the standardized therapy alone (P = 0.316). Of the subjects who achieved complete healing, there was evidence for preferential healing of ulcers with baseline areas less than 1.46 cm² for Regranex Gel treatment (P = 0.0286). The integrated analysis showed that becaplermin 100 µg/g was superior to vehicle gel (P = 0.015) and standardized care (P = 0.002) in achieving complete healing. In the ulcers less than or equal to 10 cm² in area, the becaplermin gel 100 µg/g was also superior to vehicle gel (P = 0.011) and standardized care (P = 0.006). Significant differences were seen among treatment groups (P = 0.010; Cox's Proportional Hazards Analysis). The Kaplan-Meier estimate of the 35th percentile for the time to complete healing was 99 days for becaplermin gel 100 µg/g versus 141 days for the vehicle. Conclusion: The results of the pooled integrated analyses are consistent with those reported from the 4 preapproval studies showing that Regranex Gel 0.01% significantly increases the incidence of complete healing and reduces the time...
- Subjects
PLATELET-derived growth factor; GRANULATION tissue; ULCERS; THERAPEUTICS; WOUND healing
- Publication
Journal of Applied Research, 2005, Vol 5, Issue 1, p35
- ISSN
1537-064X
- Publication type
Article