3C Patch® Medicare Claims Study

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03997526
Study type	Observational
Source	Reapplix
Contact
Status	Terminated
Phase
Start date	July 15, 2020
Completion date	February 21, 2022

View Details

See also
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