Recombinant human platelet‐derived growth factor‐BB (becaplermin) for healing chronic lower extremity diabetic ulcers: an open‐label clinical evaluation of efficacy

Abstract

Topically applied recombinant human platelet-derived growth factor-BB (becaplermin) is a new pharmacologically active therapy for chronic, neuropathic, lower extremity diabetic ulcers. In previous studies, becaplermin gel was administered once daily but dressings were changed twice daily. In the present study of 134 patients with diabetes mellitus and full thickness lower extremity ulcers, dressings were changed only once per day, simplifying the treatment regimen. Efficacy criteria included the percentage of patients achieving complete healing within the 20-week treatment period, the time to achieve complete healing, the rate of ulcer recurrence during the 6-month period following healing, and treatment compliance. Complete healing of ulcers was achieved in 57. 5% of patients, with a mean time to closure of 63 days and a recurrence rate of 21% at 6 months. Of the potential factors affecting ulcer healing, only drug compliance (p < 0.001), dressing compliance (p < 0.01), the presence of infection (p < 0.01), baseline ulcer area (p < 0.05), and baseline total wound evaluation score (p < 0.05) were significantly associated with healing. Results of this study further confirm the efficacy and safety of becaplermin gel for the treatment of lower extremity diabetic ulcers.

Variation of pH in lysed platelet concentrates influence proliferation and alkaline phosphatase activity in human osteoblast-like cells

“…The acid tide of wound healing, i.e., the pH within wounds and fractures, change from acidic to neutral and alkaline pH as the healing process progress (18)(19)(20)(21)(22)(23)(24). The local environment is acidic during the initial stage of healing.…”

“…Platelets, platelet-rich plasma (PRP), platelet lysates, platelet-derived growth factor (PDGF), and supernatants from activated platelets all have well-known stimulatory effects on mesenchymal cells in vitro (4-10) and in vivo (11). The clinical potential of platelet constituents is interesting and several clinical trials and observations on wound healing and bone formation have been published (12)(13)(14)(15)(16)(17)(18). Previously, it has also been described that mineralization and bone repair is pH dependent.…”

Human Epidermal Growth Factor Enhances Healing of Diabetic Foot Ulcers

“…In a large multicenter study, PDGF, at a concentration of 100 g/g in cream, gave a better healing rate (50%) than the placebo group (35%) in a 20-week study (P ϭ 0.007) (17). In an open-label study, Embil et al (19) reported a complete healing rate of 57.5%, with a daily local application of PDGF cream, in chronic diabetic foot ulcer patients. The wide healing ranges shown above probably reflect differences in study design, duration of study, and patient and ulcer characteristics.…”

Calreticulin Enhances Porcine Wound Repair by Diverse Biological Effects

“…Regranex (PDGF-BB), the first and only Food and Drug Administration-approved cytokine (protein) treatment for cutaneous wound repair, was used as a positive control in the wound healing experiments. 30,43,44 The percentage of epithelial resurfacing (percent re-epithelialized) with 5.0 mg/ml CRT (100 g/wound) was 58% compared to 41% and 44% for the PDGF-BB-treated and buffer-treated wounds, respectively, at 5 days after injury ( Figure 1A). As shown, by 10 days after wounding, the CRT-treated and control wounds were 100% re-epithelialized ( Figure 2, A, B, D, E).…”