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

Scott Lipkin, DPM, Elliot Chaikof, MD, PhD, Zevi Isseroff, DPM, Paul Silverstein, MD

Disclosures

Wounds. 2003;15(7) 

In This Article

Abstract and Introduction

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.

Patients with diabetes are at increased risk of developing foot ulcers. Peripheral neuropathy increases the likelihood of foot injury, and peripheral vascular disease reduces normal healing of minor trauma, allowing development of ulcers. It is estimated that 15 percent of patients with type 1 or type 2 diabetes will develop an ulcer on a foot or ankle within the course of the disease.[1,2] Current standard care for diabetic foot ulcers includes removal of mechanical stress, sharp wound debridement, and use of dressings to maintain a moist wound environment.[2] In addition, infections of the wound site must be managed. Rates of healing with standard care are 24 percent after 12 weeks.[3] A majority of patients with failure of wound healing ultimately require surgery or amputation, and ulcers contribute to 85 percent of lower-extremity amputations for patients with diabetes.[4,5] The development of a new foot ulcer by a 40- to 65-year-old man can generate nearly $28,000 in additional cost of care during the two years after diagnosis.[6]

The need to improve the success rate of healing in diabetic ulcers has prompted new therapeutic approaches. Biologic dressings, such as cultured epidermal allografts, can promote healing of a variety of wounds, including burns, venous ulcers, and split-thickness skin graft donor sites.[7,8,9,10,11,12,13] Because the allograft cells survive only briefly and do not become a permanent part of the regenerating tissue,[14] the postulated mechanism of action of cultured grafts is stimulation of wound repair through the release of multiple cytokines and matrix components.[15,16,17,18]

Bilayered cellular matrix (BCM, OrCelTM, Ortec International, New York, New York) is a porous collagen sponge containing cocultured allogeneic keratinocytes and fibroblasts harvested from human neonatal foreskin. This device has been approved for use in the United States (US) by the Food and Drug Administration (FDA) for the treatment of split-thickness donor sites of burn patients and in patients with mitten-hand deformities secondary to recessive dystrophic epidermolysis bullosa (RDEB).[19] BCM is not approved by the FDA for use on diabetic foot ulcers. The objective of the current study was to examine the effectiveness and safety of treatment of diabetic neuropathic foot ulcers using BCM plus standard care compared with standard care alone.

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