Trials / Completed
CompletedNCT03636867
Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia
Prospective Evaluation of Laboratory, Cellular and Molecular Determinants of Clinical Success of the Treatment in Diabetic Patients With Critical Limb Ischemia (ECAD-CLI) Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 236 (actual)
- Sponsor
- Maria Cecilia Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The ECAD-CLI is an investigator-driven, prospective, single-center study. The aim of the study is to prospectively collect clinical, laboratory, angiographic, cellular and molecular variables related to prognosis and outcome in patients with diabetes mellitus and critical limb ischemia.
Detailed 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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | data and specimen collection | to identify laboratory, cellular and molecular determinants of clinical success after treatment, several clinical information and specimens will be collected by Authors from each patient |
Timeline
- Start date
- 2018-08-07
- Primary completion
- 2020-08-31
- Completion
- 2020-08-31
- First posted
- 2018-08-17
- Last updated
- 2023-03-24
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03636867. Inclusion in this directory is not an endorsement.