Reapplix 3C Patch® System for the Treatment of Diabetic Foot Ulcers: A Medicare Claims Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 6
- 主要终点
- Complete healing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Complete healing
时间窗: 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®.
次要结局
- Major amputation - target limb(24 weeks)
- Minor amputation - contralateral limb(24 weeks)
- Number of 3C Patch® treatments administered(20 weeks)
- Major amputation - contralateral limb(24 weeks)
- Minor amputation - target limb(24 weeks)