This prospective study will compare incidence rates of complete hard-to-heal diabetic foot ulcer healing in Medicare beneficiaries following application of the 3C Patch® plus usual care, tested against a historical control group of similar patients that received usual care during a randomized controlled trial.
This is a prospective, observational, longitudinal, claims-based study with a historical control group. Data will be collected via claim forms and will be extracted directly from the Centers for Medicare \& Medicaid Services (CMS) Medicare Research Identifiable Files (RIFs), which contain all medical claims for 100% of Medicare beneficiaries enrolled in the Medicare fee-for-service program. The study will be conducted in accordance with relevant guidelines of a central institutional review board (IRB), relevant informed consent regulations, and all other applicable regulatory requirements.
Study Type
OBSERVATIONAL
Enrollment
22
A platelet-rich plasma gel patch comprised of distinct fibrin, platelet, and leukocyte substantially parallel layers, prepared without the use of any added reagents through a two-step centrifugation process
Mayo Clinic
Phoenix, Arizona, United States
Natchitoches Regional Medical Center
Natchitoches, Louisiana, United States
Opelousas General Hospital Wound Center
Opelousas, Louisiana, United States
Southeast Wound Care and Hyperbaric Medical Center
Cape Girardeau, Missouri, United States
Complete healing
Rate (%) of complete healing of hard-to-heal diabetic foot ulcers in Medicare beneficiaries following application of the 3C Patch®.
Time frame: within 20 weeks of the first application of the 3C Patch.
Number of 3C Patch® treatments administered
The number of 3C Patch® treatments administered within 20 weeks of initial application of the 3C Patch®.
Time frame: 20 weeks
Major amputation - target limb
The incidence of major (above ankle) amputation affecting the target limb by 24 weeks
Time frame: 24 weeks
Major amputation - contralateral limb
The incidence of major amputation affecting the contralateral limb by 24 weeks
Time frame: 24 weeks
Minor amputation - target limb
The incidence of minor (below ankle) amputation affecting the target limb by 24 weeks
Time frame: 24 weeks
Minor amputation - contralateral limb
The incidence of minor amputation affecting the contralateral limb by 24 weeks
Time frame: 24 weeks
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Regional One Physician Specialists
Poplar Bluff, Missouri, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States