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CLINICAL TRIAL NEWS

Section Editor(s): Hess, Cathy> Thomas BSN, RN, CWOCN

Advances in Skin & Wound Care: October 2005 - Volume 18 - Issue 8 - p 403
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Venous Ulcers

  • OrCel study. The Food and Drug Administration (FDA) has approved a clinical study design and protocol from Ortec International, Inc, New York, NY, and has authorized Ortec to initiate a confirmatory study to support the safety and effectiveness results contained in its Premarket Approval (PMA) application for OrCel, a bilayered cellular matrix. The FDA notified Ortec that it may enroll 60 patients in the study, which may be conducted at up to 10 clinical sites. Patient enrollment can begin when each site obtains institutional review board approval.
  • Clinical data from the 12-week pivotal trial submitted as part of Ortec's PMA showed that in typical venous ulcers (those ulcers to be evaluated in the confirmatory study), 59% of the OrCel-treated patients achieved wound closure, versus 36% of the patients who received the standard of care treatment (P = .034). OrCel-treated patients demonstrated a statistically significant faster overall healing rate (P = .017) and faster healing at each visit (P = < .0001). Patients also had 64% less recurrence of their ulcers when compared with patients treated with the standard of care during the 3-month posthealing follow-up period (P = .039).
  • Glucoprime study. A recent Phase II clinical trial conducted in Australia evaluated the effect of Glucoprime, an investigational wound healing compound, on both the rate of wound closure and the degree of healing in venous ulcers. The double-blind, randomized trial involved 60 patients with chronic deep venous ulcers. Patients were randomized to either a placebo arm or to a low-dose (0.1%) or a high-dose (1%) Glucoprime arm. The placebo or the active product was applied to the wound surface 3 times a week for 12 weeks Ulcers were monitored for size every 2 weeks.
  • Glucoprime promoted the rate at which wounds healed, with Glucoprime-treated ulcers healing at a significantly faster rate (2 mm/day) compared with placebo-treated ulcers. The overall mean level of healing over the 12 weeks was 10% for the placebo group, 59% for the low-dose Glucoprime arm, and 55% for the high-dose Glucoprime arm.
  • Glucoprime is a product of Novogen, Stamford, CT.

Digital Ulcers

  • Bosentan study. In a preliminary analysis of a double-blind, placebo-controlled, randomized, Phase III study, bosentan (Tracleer) was found to reduce the occurrence of new digital ulcers during a 6-month treatment period in patients with systemic sclerosis. This statistically significant result confirms the positive findings from an earlier trial of bosentan, a dual endothelin-receptor antagonist. Bosentan is a product of Actelion Ltd, Basel, Switzerland.
  • The latest study, which involved 190 patients, also evaluated the effect of bosentan on time-to-healing of existing digital ulceration in this population. No difference in time-to-healing was observed between patients receiving placebo and those receiving bosentan. The safety profile of bosentan in this study was comparable to that observed in previous clinical trials and in postmarketing experience.
  • Bosentan is currently approved to treat pulmonary arterial hypertension.
© 2005 Lippincott Williams & Wilkins, Inc.