3C Patch® Medicare Claims Study

NCT ID: NCT03997526

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2022-02-21

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

3C Patch

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reapplix

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Regional One Physician Specialists

Poplar Bluff, Missouri, United States

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30243803 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25853474 (View on PubMed)

Other Identifiers

REAPCEDUS01

Identifier Type: -

Identifier Source: org_study_id