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.

Chronic ulcers are a significant and common cause of morbidity and mortality worldwide. They disrupt the epidermis and dermis, resulting in a loss of barrier function. Keloids and hypertrophic scars (benign cutaneous tumors) represent an abnormal healing response. These fibroproliferative disorders are characterized by an overabundance of collagen and accumulation of extracellular matrix due to an imbalance between synthesis and degradation, culminating in excessive scarring. The objectives of this study were to evaluate and compare noninvasive biophysical methods for the measurement of outstanding quantitative parameters of scars and chronic ulcers, and to establish correlations between the parameters measured and the results of conventional subjective clinical evaluations. The development of new technologies, based on ultrasonography and laser Doppler, makes possible new dermatological evaluation methods. Fifteen patients (6 females and 9 males) with 15 chronic ulcers (4 diabetic ulcers, 10 venous ulcers and 1 pressure ulcer) and 30 patients (19 females and 11 males) with 30 scars (25 hypertrophic and 5 keloids) were included in this study. Clinical evaluation was performed by a dermatologist, an aesthetic surgeon and an endocrinologist. Biophysical measurements were used to assess local blood flow by laser Doppler flowmetry (Moor DRT4), thickness and echogenicity by high frequency ultrasonography (20 MHz, Dermascan C) and ulcer linear dimensions by image analysis. Our results show that blood flow within the ulcers and scars was higher than within normal skin. Also, skin thickness of chronic ulcers was decreased when compared to normal skin; the thickness of hypertrophic scars, but not of keloids, was increased in comparison to normal skin, and presented the possibility of measuring wound and scar surfaces with precision. In summary, this pilot study established the feasibility of measuring various biophysical parameters and adapted their potential utility to research on wounds.

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