Effectiveness of Bilayered Cellular Matrix in Healing of Neuropathic Diabetic Foot Ulcers: Results of a Multicenter Pilot Trial.

Objective: The objective of this study was to assess the effectiveness of bilayered cellular matrix (BCM) (OrCel®, Ortec International, New York, New York) in treating diabetic neuropathic foot ulcers.Research Design and Methods: This was a multicenter, randomized, controlled, parallel-group pilot study of 40 patients with chronic, diabetic, neuropathic foot ulcers. Standard care consisted of moist saline gauze cover for up to 12 weeks (n = 20). Patients in the active treatment group (n = 20) received standard care plus an application of BCM at each weekly visit for up to six total applications, followed by standard care alone for an additional six weeks or until complete healing. Both groups received weekly sharp wound debridement as necessary and foot pressure relief. Wound healing was quantified by planimetry of epithelialized areas.Results: By 12 weeks, 7 of 20 wounds treated with BCM showed complete healing compared with 4 of 20 wounds treated with standard care. In the class of wounds that were ≤ 6cm2 initial size, complete healing occurred in 7 of 15 (47%) treated with BCM, compared with 3 of 13 (23%) treated with standard care (p = 0.1939). Mean rates of wound closure over the course of the trial were faster for BCM-treated wounds compared with standard care (1.8% per day vs 1.1% percent per day, p = 0.0087). There were no treatment-related adverse events in either treatment group.Conclusions: Diabetic neuropathic foot ulcers treated with BCM showed a faster rate of wound healing than those treated with standard care alone. By study endpoint, a larger proportion of ulcers treated with BCM had healed completely than ulcers receiving standard treatment. Treatment with BCM was well tolerated