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3C Patch® Medicare Claims Study

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ClinicalTrials.gov Identifier: NCT03997526
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Reapplix

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.

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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
Estimated Study Start Date : July 30, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
3C Patch treatment
Medicare beneficiaries (aged 65 years and over) 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




Primary Outcome Measures :
  1. Complete healing [ Time Frame: within 20 weeks of the first application of the 3C Patch. ]
    % of ulcers with complete epithelialization without discharge


Secondary Outcome Measures :
  1. Time to healing [ Time Frame: within 20 weeks ]
    Time (weeks) to healing in those wounds that heal by 20 weeks

  2. 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

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

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

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

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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Medicare beneficiaries (aged 65 years and over) diagnosed with diabetic foot ulcer
Criteria

Inclusion Criteria:

  • Medicare beneficiaries (aged 65 years and over) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997526


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

Sponsors and Collaborators
Reapplix

Publications:
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Responsible Party: Reapplix
ClinicalTrials.gov Identifier: NCT03997526     History of Changes
Other Study ID Numbers: REAPCEDUS01
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Reapplix:
3C Patch
Reapplix
LeucoPatch

Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases