Diabetes Care, Vol 21, Issue 5 822-827, Copyright © 1998 by American Diabetes Association

ARTICLES

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

TJ Wieman, JM Smiell and Y Su
Department of Surgery, University of Louisville School of Medicine, Kentucky, USA.

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.
CiteULike    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

				G. Spinetti, N. Kraenkel, C. Emanueli, and P. Madeddu Diabetes and vessel wall remodelling: from mechanistic insights to regenerative therapies Cardiovasc Res, May 1, 2008; 78(2): 265 - 273. [Abstract] [Full Text] [PDF]

				Z. T. Bloomgarden The Diabetic Foot Diabetes Care, February 1, 2008; 31(2): 372 - 376. [Full Text] [PDF]

				J. O. Hollinger, C. E. Hart, S. N. Hirsch, S. Lynch, and G. E. Friedlaender Recombinant Human Platelet-Derived Growth Factor: Biology and Clinical Applications J. Bone Joint Surg. Am., February 1, 2008; 90(Supplement_1): 48 - 54. [Abstract] [Full Text] [PDF]

				N. Papanas and E. Maltezos Growth Factors in the Treatment of Diabetic Foot Ulcers: New Technologies, Any Promises? International Journal of Lower Extremity Wounds, March 1, 2007; 6(1): 37 - 53. [Abstract] [PDF]

				I. Goren, E. Muller, J. Pfeilschifter, and S. Frank Severely Impaired Insulin Signaling in Chronic Wounds of Diabetic ob/ob Mice: A Potential Role of Tumor Necrosis Factor-{alpha} Am. J. Pathol., March 1, 2006; 168(3): 765 - 777. [Abstract] [Full Text] [PDF]

				A. J.M. Boulton, R. S. Kirsner, and L. Vileikyte Neuropathic Diabetic Foot Ulcers N. Engl. J. Med., July 1, 2004; 351(1): 48 - 55. [Full Text] [PDF]

				D. T. Rovee The Changing Lexicon of Wound Treatment International Journal of Lower Extremity Wounds, June 1, 2004; 3(2): 62 - 63. [PDF]

				D. J. Margolis The Swings and Roundabouts of Randomized Controlled Studies in Wound Healing International Journal of Lower Extremity Wounds, March 1, 2004; 3(1): 4 - 6. [PDF]

				C. L. Smith Pharmacotherapy of Diabetic Foot Ulcers Journal of Pharmacy Practice, February 1, 2004; 17(1): 66 - 74. [Abstract] [PDF]

				C. Caravaggi, R. De Giglio, C. Pritelli, M. Sommaria, S. Dalla Noce, E. Faglia, M. Mantero, G. Clerici, P. Fratino, L. Dalla Paola, et al. HYAFF 11-Based Autologous Dermal and Epidermal Grafts in the Treatment of Noninfected Diabetic Plantar and Dorsal Foot Ulcers: A prospective, multicenter, controlled, randomized clinical trial Diabetes Care, October 1, 2003; 26(10): 2853 - 2859. [Abstract] [Full Text] [PDF]

				M. W. Tsang, W. K. R. Wong, C. S. Hung, K.-M. Lai, W. Tang, E. Y.N. Cheung, G. Kam, L. Leung, C. W. Chan, C. M. Chu, et al. Human Epidermal Growth Factor Enhances Healing of Diabetic Foot Ulcers Diabetes Care, June 1, 2003; 26(6): 1856 - 1861. [Abstract] [Full Text] [PDF]

				P. Sheehan, P. Jones, A. Caselli, J. M. Giurini, and A. Veves Percent Change in Wound Area of Diabetic Foot Ulcers Over a 4-Week Period Is a Robust Predictor of Complete Healing in a 12-Week Prospective Trial Diabetes Care, June 1, 2003; 26(6): 1879 - 1882. [Abstract] [Full Text] [PDF]

				D. J. Margolis, L. Allen-Taylor, O. Hoffstad, and J. A. Berlin Diabetic Neuropathic Foot Ulcers: The association of wound size, wound duration, and wound grade on healing Diabetes Care, October 1, 2002; 25(10): 1835 - 1839. [Abstract] [Full Text] [PDF]

				A. Veves, P. Sheehan, H. T. Pham, and for the Promogran Diabetic Foot Ulcer Study A Randomized, Controlled Trial of Promogran (a Collagen/Oxidized Regenerated Cellulose Dressing) vs Standard Treatment in the Management of Diabetic Foot Ulcers Arch Surg, July 1, 2002; 137(7): 822 - 827. [Abstract] [Full Text] [PDF]

				J. Yoon, J. Giacopelli, D. Granoff, and W. Kobayashi Treatment of Scleroderma Skin Ulcers Using Becaplermin Gel and Hydrocolloid Membrane J Am Podiatr Med Assoc, June 1, 2002; 92(6): 350 - 354. [Abstract] [Full Text] [PDF]

				I. Yassur, M. J. Hirschbein, and J. W. Karesh 0.01% Becaplermin Gel for the Treatment of a Chronic Orbital Ulcer After Exenteration Arch Ophthalmol, December 1, 2001; 119(12): 1858 - 1859. [Full Text] [PDF]

				G. D. Mulder Diabetic foot ulcers: old problems--new technologies Nephrol. Dial. Transplant., April 1, 2001; 16(4): 695 - 698. [Full Text] [PDF]

				L. Q. Corbett and C. T. Milne Wound Care in the Age of PPS: Tools for Survival Home Health Care Management Practice, February 1, 2001; 13(2): 93 - 105. [Abstract] [PDF]

				D. J. Margolis, J. Kantor, J. Santanna, B. L. Strom, and J. A. Berlin Risk Factors for Delayed Healing of Neuropathic Diabetic Foot Ulcers: A Pooled Analysis Arch Dermatol, December 1, 2000; 136(12): 1531 - 1535. [Abstract] [Full Text] [PDF]

				Y. M. Bello and T. J. Phillips Recent Advances in Wound Healing JAMA, February 9, 2000; 283(6): 716 - 718. [Full Text] [PDF]

				Topical Platelet-Derived Growth Factor for Diabetic Foot Ulcers Journal Watch Dermatology, July 1, 1998; 1998(701): 13 - 13. [Full Text]

				Topical Platelet-Derived Growth Factor for Diabetic Foot Ulcers Journal Watch (General), May 29, 1998; 1998(529): 4 - 4. [Full Text]