Diabetic Foot Ulcer
Conditions
Keywords
3C Patch, Reapplix, LeucoPatch
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.
Interventions
DEVICE3C 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
Sponsors
Reapplix
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete healing | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of 3C Patch® treatments administered | 20 weeks | The number of 3C Patch® treatments administered within 20 weeks of initial application of the 3C Patch®. |
| Major amputation - target limb | 24 weeks | The incidence of major (above ankle) amputation affecting the target limb by 24 weeks |
| Major amputation - contralateral limb | 24 weeks | The incidence of major amputation affecting the contralateral limb by 24 weeks |
| Minor amputation - target limb | 24 weeks | The incidence of minor (below ankle) amputation affecting the target limb by 24 weeks |
| Minor amputation - contralateral limb | 24 weeks | The incidence of minor amputation affecting the contralateral limb by 24 weeks |
Countries
United States
Outcome results
None listed