Natchitoches, Louisiana 27514

  • Diabetic Foot Ulcer

Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT03997526


Primary Contact:

Jennifer Saab, MSM,CPMA,COC
Phone: 610-421-6369
Email: jms@reapplix.com


Backup Contact:

Email: rl@reapplix.com
Rasmus Lundquist, M.Sc


Location Contact:

Natchitoches, Louisiana 27514
United States

Marcus Stokes, MD
Phone: 318-214-4822
Email: Jamie.Fontana@nrmchospital.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.