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出境医 / 临床实验 / 3C Patch® Medicare Claims Study

3C Patch® Medicare Claims Study

Study Description
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.

Condition or disease Intervention/treatment
Diabetic Foot Ulcer 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 Design
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Study Type : Observational
Estimated Enrollment : 2680 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Reapplix 3C Patch® System for the Treatment of Diabetic Foot Ulcers: A Medicare Claims Study
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022
Arms 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
Outcome Measures
Primary Outcome Measures :
  1. Complete healing [ Time Frame: within 20 weeks of the first application of the 3C Patch. ]
    Rate (%) of complete healing of hard-to-heal diabetic foot ulcers in Medicare beneficiaries following application of the 3C Patch®.


Secondary Outcome Measures :
  1. Number of 3C Patch® treatments administered [ Time Frame: 20 weeks ]
    The number of 3C Patch® treatments administered within 20 weeks of initial application of the 3C Patch®.

  2. Major amputation - target limb [ Time Frame: 24 weeks ]
    The incidence of major (above ankle) amputation affecting the target limb by 24 weeks

  3. Major amputation - contralateral limb [ Time Frame: 24 weeks ]
    The incidence of major amputation affecting the contralateral limb by 24 weeks

  4. Minor amputation - target limb [ Time Frame: 24 weeks ]
    The incidence of minor (below ankle) amputation affecting the target limb by 24 weeks

  5. Minor amputation - contralateral limb [ Time Frame: 24 weeks ]
    The incidence of minor amputation affecting the contralateral limb by 24 weeks


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Medicare beneficiaries diagnosed with diabetic foot ulcer
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
Contacts and Locations

Contacts
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Contact: Jennifer Saab, MSM,CPMA,COC 610-421-6369 jms@reapplix.com
Contact: Rasmus Lundquist, M.Sc rl@reapplix.com

Locations
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United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 84054
Contact: Katrina Stanchfield    480-342-6055    mailto:stanchfield.katrina@mayo.edu   
Principal Investigator: Erwin A Kruger, MD         
United States, Louisiana
Natchitoches Regional Medical Center Recruiting
Natchitoches, Louisiana, United States, 27514
Contact: Marcus Stokes, MD    318-214-4822    Jamie.Fontana@nrmchospital.org   
Opelousas General Hospital Wound Center Recruiting
Opelousas, Louisiana, United States, 70570
Contact: Kerry T. Thibodeaux, MD         
United States, Missouri
Southeast Wound Care and Hyperbaric Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Juliana Lippert-Keck, MD       mailto:dpayne2@sehealth.org   
Contact: Donna Payne       mailto:dpayne2@sehealth.org   
Principal Investigator: Juliana Lippert-Keck, MD         
Regional One Physician Specialists Recruiting
Poplar Bluff, Missouri, United States, 63901
Contact: Robert Dorsey, MD         
Principal Investigator: Robert Dorsey         
United States, North Carolina
UNC Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: William A Marston, MD    919-966-3391    William_marston@med.unc.edu   
Sponsors and Collaborators
Reapplix
Tracking Information
First Submitted Date June 21, 2019
First Posted Date June 25, 2019
Last Update Posted Date April 8, 2021
Actual Study Start Date July 15, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2020) 		Complete healing [ Time Frame: within 20 weeks of the first application of the 3C Patch. ]
Rate (%) of complete healing of hard-to-heal diabetic foot ulcers in Medicare beneficiaries following application of the 3C Patch®.
Original Primary Outcome Measures
 (submitted: June 22, 2019) 		Complete healing [ Time Frame: within 20 weeks of the first application of the 3C Patch. ]
% of ulcers with complete epithelialization without discharge
Change History
Current Secondary Outcome Measures
 (submitted: May 8, 2020)
  • Number of 3C Patch® treatments administered [ Time Frame: 20 weeks ]
    The number of 3C Patch® treatments administered within 20 weeks of initial application of the 3C Patch®.
  • Major amputation - target limb [ Time Frame: 24 weeks ]
    The incidence of major (above ankle) amputation affecting the target limb by 24 weeks
  • Major amputation - contralateral limb [ Time Frame: 24 weeks ]
    The incidence of major amputation affecting the contralateral limb by 24 weeks
  • Minor amputation - target limb [ Time Frame: 24 weeks ]
    The incidence of minor (below ankle) amputation affecting the target limb by 24 weeks
  • Minor amputation - contralateral limb [ Time Frame: 24 weeks ]
    The incidence of minor amputation affecting the contralateral limb by 24 weeks
Original Secondary Outcome Measures
 (submitted: June 22, 2019)
  • Time to healing [ Time Frame: within 20 weeks ]
    Time (weeks) to healing in those wounds that heal by 20 weeks
  • Durability of wound healing [ Time Frame: 12 weeks from healing ]
    Durability of the healed wounds - 12 weeks after healing. Wound status (healed/unhealed) will be assessed from claim records
  • Major amputation - target limb [ Time Frame: 24 weeks ]
    The incidence of major (above ankle) amputation affecting the target limb by 24 weeks
  • Major amputation - contralateral limb [ Time Frame: 24 weeks ]
    The incidence of major amputation affecting the contralateral limb by 24 weeks
  • Minor amputation - target limb [ Time Frame: 24 weeks ]
    The incidence of minor (below ankle) amputation affecting the target limb by 24 weeks
  • Minor amputation - contralateral limb [ Time Frame: 24 weeks ]
    The incidence of minor amputation affecting the contralateral limb by 24 weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 3C Patch® Medicare Claims Study
Official Title Reapplix 3C Patch® System for the Treatment of Diabetic Foot Ulcers: A Medicare Claims Study
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Medicare beneficiaries diagnosed with diabetic foot ulcer
Condition Diabetic Foot Ulcer
Intervention 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
Study Groups/Cohorts 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)
Intervention: Device: 3C Patch
Publications *
  • Game F, Jeffcoate W, Tarnow L, Jacobsen JL, Whitham DJ, Harrison EF, Ellender SJ, Fitzsimmons D, Löndahl 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.
  • Löndahl M, Tarnow L, Karlsmark T, Lundquist R, Nielsen AM, Michelsen M, Nilsson A, Zakrzewski M, Jörgensen 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 22, 2019) 		2680
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Jennifer Saab, MSM,CPMA,COC 610-421-6369 jms@reapplix.com
Contact: Rasmus Lundquist, M.Sc rl@reapplix.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03997526
Other Study ID Numbers REAPCEDUS01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Reapplix
Study Sponsor Reapplix
Collaborators Not Provided
Investigators Not Provided
PRS Account Reapplix
Verification Date April 2021

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