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3C Patch® Medicare Claims Study

NCT03997526 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2022-03-09

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer

Interventions

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

Sponsors & Collaborators

  • Reapplix

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2022-02-21
Completion
2022-02-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03997526 on ClinicalTrials.gov