3C Patch® Medicare Claims Study

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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: 3C Patch

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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 84054
      • Mayo Clinic
  • Louisiana
    • Natchitoches, Louisiana, United States, 27514
      • Natchitoches Regional Medical Center
    • Opelousas, Louisiana, United States, 70570
      • Opelousas General Hospital Wound Center
  • Missouri
    • Cape Girardeau, Missouri, United States, 63703
      • Southeast Wound Care and Hyperbaric Medical Center
    • Poplar Bluff, Missouri, United States, 63901
      • Regional One Physician Specialists
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Medicare beneficiaries diagnosed with diabetic foot ulcer

Description

Inclusion Criteria:

• Medicare beneficiaries diagnosed with diabetic foot ulcer and receiving at least one treatment with the 3C Patch® System.
• Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will decrease by less than 50% during a four week period prior to the first application of the 3C Patch® (percentage change in cross-sectional area determined clinically by the treating physician by estimation at examination).
• Eligible ulcer's cross-sectional area will increase by less than 25% during a 4-week period prior to the first application of the 3C Patch® (percentage change determined clinically by treating physician by estimation at examination)
• The cross-sectional area of the index ulcer will be ≥50 and ≤1000 mm2 at the end of the 4 week period prior to the first application of the 3C Patch® (size determined clinically by the treating physician by estimation at examination).
• Participants will have the capacity to understand study procedures, and will be able to provide written informed consent.

Exclusion Criteria:

• Presence of sickle-cell anemia, hemophilia, thrombocytopenia (<100x109/L) or other clinically significant blood dyscrasia
• Known potential infectivity of blood products, including known HIV and hepatitis
• Patient in dialysis
• Clinical signs of infection of the index ulcer or reason to suspect that infection is present
• Revascularization procedure in the affected limb planned, or undertaken within the 4 weeks prior to the first application of the 3C Patch®
• Current treatment with cytotoxic drugs or with systemically administered glucocorticoids or other immunosuppressants
• Treatment of foot ulcers with growth factors, stem cells or equivalent preparation within the 8 weeks prior to the first application of the 3C Patch®
• The need for continued use of negative pressure wound therapy
• Likely inability to comply with the need for follow up visits because of planned activity
• Participation in another interventional clinical foot ulcer-healing trial within the 4 weeks prior to the first application of the 3C Patch®
• Prior enrollment in this study
• Judgement by the investigator that the patient does not have the capacity to understand the study procedures or provide written informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

3C Patch treatment; Medicare beneficiaries with diabetes and hard-to-heal non-healing ulcers of the foot will receive usual care (i.e., care consistent with the IWGDF guidance on use of interventions to enhance the healing of chronic ulcers of the foot in diabetes) supplemented by the application of the 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)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete healing	Rate (%) of complete healing of hard-to-heal diabetic foot ulcers in Medicare beneficiaries following application of the 3C Patch®.	within 20 weeks of the first application of the 3C Patch.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of 3C Patch® treatments administered	The number of 3C Patch® treatments administered within 20 weeks of initial application of the 3C Patch®.	20 weeks
Major amputation - target limb	The incidence of major (above ankle) amputation affecting the target limb by 24 weeks	24 weeks
Major amputation - contralateral limb	The incidence of major amputation affecting the contralateral limb by 24 weeks	24 weeks
Minor amputation - target limb	The incidence of minor (below ankle) amputation affecting the target limb by 24 weeks	24 weeks
Minor amputation - contralateral limb	The incidence of minor amputation affecting the contralateral limb by 24 weeks	24 weeks

Collaborators and Investigators

• Sponsor: Reapplix

Publications and helpful links

General Publications

• Game F, Jeffcoate W, Tarnow L, Jacobsen JL, Whitham DJ, Harrison EF, Ellender SJ, Fitzsimmons D, Londahl M; LeucoPatch II trial team. LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked, randomised controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):870-878. doi: 10.1016/S2213-8587(18)30240-7. Epub 2018 Sep 19.
• Londahl M, Tarnow L, Karlsmark T, Lundquist R, Nielsen AM, Michelsen M, Nilsson A, Zakrzewski M, Jorgensen B. Use of an autologous leucocyte and platelet-rich fibrin patch on hard-to-heal DFUs: a pilot study. J Wound Care. 2015 Apr;24(4):172-4, 176-8. doi: 10.12968/jowc.2015.24.4.172.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): February 21, 2022
• Study Completion (Actual): February 21, 2022

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 22, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: 3C Patch; Reapplix; LeucoPatch
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: REAPCEDUS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No