Topical Treatment of Hypertensive Leg Ulcers With Platelet-Derived Growth Factor-BB

Abstract

Setting: Ambulatory or hospitalized patients from 17 dermatology departments. Patients: Among 64 consecutive randomized patients with 1 or more hypertensive leg ulcers who fulfilled all inclusion criteria, 59 received the allocated intervention, and findings were analyzed. Intervention: Becaplermin gel (human recombinant platelet-derived growth factor-BB, 0.1%, in hydrogel) or hydrogel dressing was applied, both in doses of 1 cm/ cm 2 , once daily for 8 weeks. Follow-up continued for 4 weeks beyond the final gel application. Main Outcome Measures: The primary end point was complete wound closure rate after 8 weeks of treatment. Secondary end points were percentages of patients with complete wound closure at week 12; changed ulcer area after treatment vs baseline; and changed ulcerrelated pain and health-related quality of life during the study. Results: Complete wound closure rates were comparable after 8 weeks for becaplermin (5 of 28 patients) and hydrogel (3 of 31 patients) (8 percentage-point difference; 95% confidence interval,-10% to 26%). No statistically significant differences were observed between the 2 groups for percentages of complete closure at week 12, changed ulcer area at week 8, or changed ulcer-related pain and quality of life during the study (PϾ.05 for all comparisons). Conclusions: Topical becaplermin gel is not superior to hydrogel dressing for hypertensive leg ulcer wound closure. Surgical management by grafting remains the most promising treatment strategy but requires further evaluation.

The use of native chemical functional groups presented by wound beds for the covalent attachment of polymeric microcarriers of bioactive factors

“…For example, exogenous delivery of growth factors by topical application has been explored. However, these approaches have generally found to be ineffective [9–11] as the soluble growth factors delivered to the wound in these approaches were either proteolysed [12], sequestered by secreted macromolecules (e.g. fibrinogen, α-2-macroglobulin) [13], or removed by exudate before reaching the wound bed.…”

Challenges and Opportunities in Drug Delivery for Wound Healing

“…23 Phase II clinical trials showed a potential therapeutic benefit in treating pressure ulcers 24 ; however, this benefit did not persist in subsequent phase III studies. 25,26 In addition, a black box warning was placed on the drug after a postmarketing retrospective cohort study that found an increased rate of mortality secondary to malignancy in certain patients. 25 Although this drug may be useful in treating diabetic neuropathic wounds, its further clinical utility is limited by its potential for dangerous side effects, as well as by a lack of significant efficacy in alternate wound settings.…”

Cutaneous Arteriolosclerosis Is Not Specific to Ischemic Hypertensive Leg Ulcers

“…Ischemic hypertensive leg ulcers (HLU) are superficial, rapidly spreading necrotic ulcers, occurring in longstanding hypertensive and/or diabetic patients over 60 years of age [1][2][3][4][5]. Arterial hypertension and diabetes have been reported in 95 and 40% of HLU patients, respectively [3][4][5].…”

“…Arterial hypertension and diabetes have been reported in 95 and 40% of HLU patients, respectively [3][4][5]. Most authors consider that the clinical presentation of HLU is characteristic, but it remains under-recognized, with a mean delay in diagnosis of 12 weeks [6].…”