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PubMed2005

Topical becaplermin improves outcomes in work related fingertip injuries.

BACKGROUND: Fingertip injuries are common and bear significant costs associated with treatment, lost work, and functional impairment. This study compared these factors in occupationally related fingertip injuries treated with becaplermin, a recombinant human platelet-derived growth factor, and those treated with surgical reconstruction. METHODS: This was a prospective controlled trial involving occupationally related fingertip injuries. Fifty men (ages 23-51) with full thickness, single fingertip injuries > or =1.5 cm(2) with or without phalangeal exposure and distal to the distal interphalangeal (DIP) joint were evaluated. Group I (n = 25) underwent treatment with daily topical becaplermin. Group II (n = 25) underwent surgical reconstruction with a skin graft or local soft tissue flap. Time to wound healing, time to return to work, associated treatment costs, and calculated functional impairment were recorded. RESULTS: Patients in Group I returned to work in significantly less time than those in Group II-10 days versus 38 days respectively). The average calculated functional impairment in Group I was 10% versus 22% in Group II. Associated treatment costs in group A were 1580 +/- 145 US Dollars compared with 6750 +/- 785 US Dollars in Group II. All differences were statistically significant at p < 0.05 CONCLUSION: In this study, the functional and economic costs were significantly less when fingertip injuries were treated with topical becaplermin than when they were treated with surgical reconstruction. This information should allow emergency and acute care physicians to treat these injuries more efficaciously and conveniently.

Accidents, Occupational↗
PubMed2001

Topical becaplermin: new preparation. A slight short-term help for some diabetic patients.

(1) The reference curative treatment for chronic ulcers in diabetic patients is to avoid pressure on the lesions, and to give appropriate local care. (2) A topical gel containing 0.01% becaplermin, a cell growth factor, is now marketed in Europe for the treatment of chronic neuropathic ulcers measuring less than 5 cm2 in diabetic patients. (3) The clinical file mainly comprises four trials, two of which were double-blind, testing two concentrations. In the largest trial, which gave the most favourable results, the lesions healed completely after 20 weeks in 50% of patients, compared with 35% of patients who used the excipient gel and received local care. (4) The optimal concentration of becaplermin gel is not known. Neither is its effect on lesions larger than 5 cm2 or its ability to prevent the need for amputation. (5) None of the clinical trials revealed any severe adverse effects (particularly tumour growth), but pharmacovigilance data are limited. (6) In practice, the very expensive topical becaplermin gel can help some patients, in whom it slightly accelerates ulcer healing.

Anticoagulants↗
PubMed2004

[Becaplermin gel (Regranex gel)].

Becaplermine gel (Regranex) is an hydrogel which contains 100 microg of Platelet Derived Growth Factor-BB (rhPDGF-BB) per gram. Regranex is presented in 15-gram multidose tubes. It has been approved as adjuvant treatment for neuropathic diabetic ulcerations of less than 5 cm2, extending into the subcutaneous tIssue, in the absence of ischemia, in conjunction with a standardised program of appropriate wound care, (control of infection, sharp debridement, provision of a moist environment and avoidance of pressure on the wound). PDGF-BB promotes cutaneous wound healing by increasing proliferation and migration of dermal fibroblasts and extracellular matrix deposition. PDGF also promotes chemotaxis of neutrophils, monocytes and smooth muscle cells in wounds. Topical application of rhPDGF-BB speeds wound healing and promotes granulation tIssue formation, synthesis of extracellular matrix and the inflammatory phase of the wound healing process in healthy and healing-impaired animal models. In clinical trials in humans, accelarated healing has been demonstrated in patients with lower extremity diabetic neuropathic ulcers and decubitus sores by increasing granulation tIssue formation and epithelialization. Local toxicity studies in humans were negative (repeated becaplermin gel application under occlusion to intact or abraded skin, dermal sensitization tests). Pharmacokinetic studies in humans have shown that systemic absorption after topical applications was minimal. In trials, systemic and local tolerance were excellent. Reported adverse effects were similar in incidence and in nature in all groups. The 0.01% Regranex gel is safe and easy to use, with single daily application. It is currently the only commercially available topical growth factor for use in cutaneous wound healing.

Becaplermin↗
PubMed2002

A meta-analytic approach to an integrated summary of efficacy: a case study of becaplermin gel.

This paper presents a case study involving a meta-analytic approach for an integrated summary of efficacy based upon four phase II and III clinical trials that comprised the basis for a Biologics License Application to the U.S. Food and Drug Administration for approval of becaplermin gel. There were substantial variations in observed response rates across the four studies that were of concern to regulatory agencies. Due to these variations and because there were various treatment combinations in the four trials, standard statistical methods for an integrated analysis of efficacy were problematic. A meta-analytic model that focused on the variations of concern was employed to permit a suitable integrated analysis. The resulting integrated analysis clarified response rate variability and provided accurate estimates of treatment effects based upon the four clinical trials. While this meta-analysis was viewed by neither regulators nor the sponsor as a confirmatory analysis, it was seen by both regulators and sponsor as strongly supportive of the efficacy of becaplermin gel.

Anticoagulants↗
PubMed1998

Preclinical promise of becaplermin (rhPDGF-BB) in wound healing.

Advances in molecular biology have made possible the production of highly purified recombinant human proteins, and recombinant human growth factors have emerged as potential therapeutic wound healing agents. Becaplermin (recombinant human platelet-derived growth factor-BB [rhPDGF-BB]) quickly emerged as one of the leading candidates for clinical trials. Before the expected therapeutic potential of rhPDGF-BB and other growth factors could be realized, a number of concerns had to be addressed (eg, would growth factors show effects in normal animals, what parameters of wound healing would be affected, and would quality of healed wounds be normal?). In animal models, rhPDGF-BB demonstrated wound healing activity, predominantly by enhancing the formation of granulation tissue, but it was not known whether this effect on granulation tissue would translate into enhanced healing of chronic skin ulcers in humans. The objective of this article is to review how the study of rhPDGF-BB in animal wound healing models has assisted in addressing the potential clinical utility of rhPDGF-BB. Results of animal studies are summarized, and the advantages and limitations of the animal models are discussed.

Animals↗
PubMedDate not supplied

Use of topical recombinant human platelet-derived growth factor-BB (becaplermin) in healing of chronic mixed arteriovenous lower extremity diabetic ulcers.

Lower extremity ulcers cause significant morbidity and mortality in patients with diabetes. The primary factors that contribute to the development of this type of ulcer are peripheral neuropathy and peripheral vascular disease, which are often accompanied by infection. Lower extremity diabetic ulcers are chronic and difficult to treat, in part due to underlying pathologic conditions in individuals with diabetes that can contribute to impaired wound healing. This article reports the author's experience with treatment of chronic lower extremity ulcers of mixed etiologies with recombinant human platelet-derived growth factor--BB [rhPDGF-BB, REGRANEX (becaplermin) Gel 0.01%] in a patient with multiple risk factors including long-standing insulin-dependent type 2 diabetes.

Administration, Topical↗
PubMed2000

Becaplermin gel (PDGF-BB) as topical wound therapy. Plastic Surgery Educational Foundation DATA Committee.

Becaplermin gel is the first topical growth factor to demonstrate therapeutic efficacy in the healing of diabetic wounds. For diabetic patients who have poorly healing ulcers despite good perfusion and a reasonable trial of wound care, this product may be of considerable benefit. It should be tried for a 2-week time period and the results objectively assessed before continuation of therapy.

Administration, Topical↗
PubMed1999

Treatment of stingray injury with topical becaplermin gel.

Stingray injuries are most commonly characterized by localized pain, ulceration, and edema; however, potentially serious sequelae may result, including tissue necrosis and life-threatening infection. This case report describes a stingray injury that had progressed to ulceration and was treated with topical application of recombinant human platelet-derived growth factor-BB (becaplermin gel 0.01%) and a standardized regimen of wound care.

Animals↗
PubMed2002

Treatment of scleroderma skin ulcers using becaplermin gel and hydrocolloid membrane.

Skin ulcers can be very painful and detrimental in patients with systemic sclerosis, or systemic scleroderma. A brief review of scleroderma skin ulcers is presented, as well as a case study that demonstrates the effectiveness of becaplermin gel supplemented by oral immunosuppressive agents in the treatment of ulcers resulting from systemic sclerosis. The time to healing (approximately 3 months) was comparable to that associated with the oral agents and surgical interventions specifically designed to help heal scleroderma ulcers. Except for incisional biopsy, no surgical procedures were performed.

Bandages↗
PubMed2001

The use of becaplermin (rhPDGF-BB) gel for chronic nonhealing ulcers. A retrospective analysis.

Chronic, nonhealing wounds have plagued health care practitioners for decades. New research and technology have allowed the wound healing process to be understood at a cellular and molecular level, including the vital role of growth factors. This article discusses the effects of platelet-derived growth factor-BB (PDGF-BB) on the wound healing process, emphasizing the inflammatory stage of wound healing and principles of wound care. Preclinical and clinical studies evaluating recombinant human PDGF-BB (rhPDGF-BB) (becaplermin gel) also are discussed. Lastly, the results of a retrospective analysis evaluating the use of rhPDGF-BB at Broadlawns Medical Center (Des Moines, IA) are presented.

Adult↗
PubMedDate not supplied

Becaplermin and necrobiosis lipoidicum diabeticorum: results of a case control pilot study.

Necrobiosis lipoidica diabeticorum (NLD) is a rare skin condition associated with diabetes, which characteristically occurs in the pretibial region of the lower limbs (Boulton et al., 1988). The lesions generally appear as well-circumscribed reddish plaques, which are most often asymptomatic, resulting primarily in cosmetic disability. Currently, there is no reliable form of treatment for NLD, although many regimens have been tried (Shall et al., 1990)

Administration, Topical↗
PubMed2001

Treatment options for diabetic neuropathic foot ulcers: a cost-effectiveness analysis.

BACKGROUND: Diabetic foot ulcers are a common problem and result in more than 85,000 lower extremity amputations each year in the United States. Studies have suggested that between 25% and 50% of costs related to inpatient diabetes care may be directly attributable to the diabetic foot. Novel treatments for these wounds, while expensive, have been reported to improve healing rates, although no formal cost effectiveness analyses have been performed in order to address the cost effectiveness of a given therapy. OBJECTIVE: To estimate the cost effectiveness of common treatment strategies for diabetic neuropathic foot ulcers. METHODS: Four main options are available for the treatment of diabetic foot ulcers: (1) standard care (SC), (2) standard treatment in a specialized wound care center (WCC), (3) treatment with becaplermin, (4) or treatment with platelet releasate (PR). We utilized effectiveness data from published clinical trials, meta-analyses, and a database that includes data on 26,599 patients with these wounds. Effectiveness was assessed as a percentage of ulcers healed at 20 and 32 weeks. RESULTS: Baseline effectiveness (with 95% confidence intervals) for SC, becaplermin, PR, and WCC care were 30.9% (26.6, 35.1), 43.0% (37.3, 48.7), 36.8% (35.4, 38.2), and 35.6% (34.8, 36.4), respectively. Cost:effectiveness ratios for PR versus SC and becaplermin versus SC were 414.40 and 36.59, respectively. Therefore the incremental cost of increasing the odds of healing by 1% over standard therapy was $414.40 for PR and $36.59 for becaplermin. CONCLUSIONS: PR, becaplermin, and WCC care all provided improved healing rates over standard care, and becaplermin was less expensive and more effective than PR after 20 weeks of care.

Ambulatory Care Facilities↗