Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-03 @ 12:33 AM
Study NCT ID:
NCT03636867
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia
Sponsor:
Maria Cecilia Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECAD-CLI
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: