Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia

Completed

• Conditions: Critical Limb Ischemia; Diabetic Foot; Diabetes Mellitus; Critical Lower Limb Ischemia
• Interventions: Other: data and specimen collection

• Registration Number: NCT03636867
• Lead Sponsor: Maria Cecilia Hospital

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.

Study Timeline

• Study Start: 2018-08-07
• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-17
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2021-08
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• diagnosis of diabetes mellitus in treatment with oral agents and/or insulin
• diagnosis of critical limb ischemia requiring medical and/or interventional treatment

Exclusion Criteria

• dialysis
• diagnosis or suspicion of malignancy
• life expectancy <1 year
• inability to guarantee clinical follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
data and specimen collection	data and specimen collection	consecutive diabetic patients admitted to Maria Cecilia Hospital for critical limb ischemia

Primary Outcome Measures

Name	Time	Method
Incidence of amputation	1-year	Occurrence of major or minor amputation

Secondary Outcome Measures

Name	Time	Method
Wound healing	1-year	occurrence of wound healing
Incidence of revascularization of peripheral arteries	1-year	any procedure (percutaneous or surgical) of revascularization of peripheral arteries
Change in WIfI class	1-year	The Wound, Ischemia and Foot Infection is the most used classification for patients with diabetic foot disease. The classification ranges from 0 to 9. The scale includes 3 items: wound extension, presence and severity of ischemia, presence and severity of ischemia. Each item ranges from 0 to 3 points.
Change in Rutherford class	1-year	The Rutherford classification is the most used scale to stratify patients with peripheral artery disease. The classification ranges from class I to class VI. Patients with critical limb ischemia show a class from IV to VI. The Rutherford class will be assessed in all patients at baseline and 1-year after to estimate the presence or not of improvement

Trial Locations

Locations (1)

Maria Cecilia Hospital; 🇮🇹 Cotignola, Ravenna, Italy