3C Patch® Medicare Claims Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: 3C Patch


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3C Patch treatment<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3C Patch, Reapplix, LeucoPatch