Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Critical Limb Ischemia
  • Critical Lower Limb Ischemia
  • Diabetes Mellitus
  • Diabetic Foot
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

All consecutive patients admitted to Maria Cecilia Hospital will be enrolled in the ECAD-CLI study. According to interventional management of the patient the following data and samples will be prospectively collected and related to outcome: medical history, cardiovascular risk factors, clinical pres...

All consecutive patients admitted to Maria Cecilia Hospital will be enrolled in the ECAD-CLI study. According to interventional management of the patient the following data and samples will be prospectively collected and related to outcome: medical history, cardiovascular risk factors, clinical presentation information related to angiography of peripheral arteries. An independent core-lab will review angiographies to assess extent and severity of peripheral artery disease information related to medical treatment, including antithrombotic agents, antimicrobics and any treatment to permit wound healing blood sample to obtain DNA, RNA and serum patient undergoing surgery and/or debridement for wound/ulcer due to diabetic foot disease will receive biopsy for specimen collection atherosclerotic plaque sample in patients undergoing atherectomy for the treatment of the peripheral artery disease All clinical variables and information obtained from blood/tissue samples will be related to outcome. Any adverse events will be judged by an independent blinded committee.

Tracking Information

NCT #
NCT03636867
Collaborators
Not Provided
Investigators
Principal Investigator: Luca Dalla Paola, MD Maria Cecilia Hospital Principal Investigator: Gianluca Campo, MD Università degli Studi di Ferrara