This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this research study is to obtain preliminary safety data of the device, KC-002, containing cultured human keratinocytes (skin cells) applied externally to a diabetic foot ulcer to promote wound healing. The proof of principal, that there is reduction in wound area, means that the KC-002 device represents a means for supplying a milieu of factors from living keratinocytes to promote wound healing in a dressing form that is removable. It is estimated that 15 percent of patients with diabetes will develop foot ulcers and that 15 <ETH> 20 percent of those will progress to lower-extremity amputation. The cost of treating diabetic foot ulcers is estimated at $28,000 over the first two years after diagnosis. The cost of amputation ranges from $20,000 to $60,000 yet it has been estimated that 85% of these amputations could be prevented. There is a need for more effective therapies which will address the deficiencies that underlie the chronic wound. Recently, clinical therapies that include the use of skin substitutes and growth factors have demonstrated that human skin cells placed on a diabetic wound induce the natural healing process. The interactive wound dressing device (KC-002) is placed on the target ulcer and removed after 7 days. All ulcers will be on the bottom of the foot and must have been present for at least 30 days. The ulcer must be free of infection, vascular disease and must not be currently treated with growth factors. The study population includes patients 18 years and older of either sex and any racial/ethnic background who have presented to the University of Michigan Wound Care Clinic a neuropathic diabetic foot ulcer and meet the inclusion/exclusion criteria. The primary outcome being evaluated is that there are no safety or sensitization problems resulting from the use of a dressing consisting of human skin cells grown on microcarrier beads in patients with diabetic foot ulcers. A secondary outcome is that there is reduction in the size of the ulcer.
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