MedPath

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.

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
NameTimeMethod
Complete healingwithin 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
NameTimeMethod
Major amputation - target limb24 weeks

The incidence of major (above ankle) amputation affecting the target limb by 24 weeks

Minor amputation - contralateral limb24 weeks

The incidence of minor amputation affecting the contralateral limb by 24 weeks

Number of 3C Patch® treatments administered20 weeks

The number of 3C Patch® treatments administered within 20 weeks of initial application of the 3C Patch®.

Major amputation - contralateral limb24 weeks

The incidence of major amputation affecting the contralateral limb by 24 weeks

Minor amputation - target limb24 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

Mayo Clinic
🇺🇸Phoenix, Arizona, United States

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