NCT03997526

3C Patch® Medicare Claims Study

Reapplix 3C Patch® System for the Treatment of Diabetic Foot Ulcers: A Medicare Claims Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Reapplix · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	3C Patch	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

Timeline

• Start date: 2020-07-15
• Primary completion: 2022-02-21
• Completion: 2022-02-21
• First posted: 2019-06-25
• Last updated: 2022-03-09

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study