Date: 2014-07-22
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in the International Wound Journal
Company: Osiris Therapeutics (USA - MD)
Product: Grafix®
Action
mechanism: Grafix® is a cryopreserved placental membrane for acute and chronic wounds. It is a flexible, conforming membrane that is applied directly at the site of the wound. Grafix is produced by Osiris\' BioSmart™ Intelligent Tissue Processing which maintains the integrity of the extracellular matrix, growth factors, and endogenous fibroblasts, epithelial cells and mesenchymal stem cells of the native tissue.
Disease: chronic diabetic foot ulcer
Therapeutic area: Metabolic diseases - Cardiovascular diseases
Country: USA
Trial
details: Protocol 302 is a single-blind, randomized, controlled multi-centered trial evaluating the efficacy and safety of weekly applications of Grafix for the treatment of chronic diabetic foot ulcers. A total of 97 patients were enrolled at 20 leading wound care centers across the United States. Patients between 18 and 80 years of age with confirmed type 1 or type 2 diabetes and chronic diabetic foot ulcers on the dorsal or plantar surface of the foot were randomized to Grafix or control at a 1:1 ratio. Ulcers had to be present for at least 4 weeks prior to randomization and be between 1 cm2 and 15 cm2 in size. Patients were excluded from the trial if the ulcer decreased with more than 30% during the one week screening period. Patients received treatment weekly for up to 12 weeks. The primary endpoint measures complete wound closure by 12 weeks as determined by the investigator and confirmed by an independent, blinded Wound Core Lab . Secondary endpoints include complete wound closure rates for those patients that complete all scheduled treatments, time to wound closure, number of applications and adverse events, including reduction in infections. Patients randomized to control, who did not heal within 12 weeks, entered a cross-over arm for evaluation in an additional 12 week open-label treatment with Grafix.
Latest
news: * On July 22, 2014, Osiris Therapeutics announced that the manuscript from its multi-center (n=20), randomized, controlled clinical trial comparing the safety and effectiveness of Grafix® to control in patients with chronic diabetic foot ulcers (DFUs), which was accepted for publication in the International Wound Journal , is now available online and will also be in an upcoming issue. The peer-reviewed journal reports findings from Osiris\' trial, Protocol 302, which demonstrated the overwhelming efficacy of Grafix compared to control in the closure of DFUs over 12 weeks (62% vs. 21.3%, p=0.0001, n=97). Entitled \"The Efficacy and Safety of Grafix for the Treatment of Chronic Diabetic Foot Ulcers: Results of a Multi-center, Controlled, Randomized, Blinded, Clinical Trial\", the publication also highlights the trial\'s secondary endpoints - all of which showed statistically significant improvements for patients treated with Grafix compared to control. Grafix was not only favored in time to wound closure (42 days vs. 70 days, p=0.019), number of treatment applications (6 vs. 12, p=0.0001) and probability of wound closure by 12 weeks (67.1% vs. 27.1%, p < 0.0001) but also in important safety endpoints including number of patients with adverse events (44% vs. 66%, p=0.031) and wound related infections (18% vs. 36.2%, p=0.044).
