Diabetes Clinical Trial
Official title:
A Prospective, Randomized, Controlled, Unmasked, Multiple Treatment, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of an Interactive Wound Dressing Containing Cultured Keratinocytes Versus Conventional Wound Therapy for the Treatment of Diabetic Foot Ulcers
The objective of this study is to determine the safety and effectiveness of a device (the
KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as
compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2
diabetes mellitus.
This is a prospective, randomized, multi-center, unmasked, controlled study. All patients
will receive care for the diabetic foot ulcer during the study.
Participation in the study is for 24 weeks.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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