3c patch® medicare claims study

Conditions: Diabetic Foot Ulcer

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.

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.

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

Keywords: 3c patch reapplix leucopatch