3C Patch® Medicare Claims Study

Terminated

• Conditions: Diabetic Foot Ulcer

• Registration Number: NCT03997526
• Lead Sponsor: Reapplix

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.

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-22
• Study First Posted: 2019-06-25
• Study Start: 2020-07-15
• Status Verified: 2022-02
• Primary Completion: 2022-02-21
• Study Completion: 2022-02-21
• Last Update Submitted: 2022-02-21
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Major amputation - target limb	24 weeks	The incidence of major (above 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
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 - 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

Trial Locations

Locations (6)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States

Natchitoches Regional Medical Center; 🇺🇸 Natchitoches, Louisiana, United States

Opelousas General Hospital Wound Center; 🇺🇸 Opelousas, Louisiana, United States

Southeast Wound Care and Hyperbaric Medical Center; 🇺🇸 Cape Girardeau, Missouri, United States

Regional One Physician Specialists; 🇺🇸 Poplar Bluff, Missouri, United States

UNC Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States