Matrix Metalloproteinases in Patients With Critical Limb Ischemia Undergoing Surgical Revascularization

NCT02388867 | Completed DMC

• 1 other identifier: ER.ALL.2014.10.A
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the present study the investigators will evaluate MMPs. serum levels variations in patients affected by critical limb ischemia, before and after lower limb surgical revascularization through venous or prosthetic bypass.

Conditions

Critical Limb Ischemia; Extracellular Matrix Alteration; Peripheral Revascularisation

Outcome Measures

Primary Outcomes (1)

• MMPs evaluation

  MMPs plasma levels will be evaluated during follow up.

  24 months

Study Arms (2)

Group I

EXPERIMENTAL

Intervention: Polytetrafluoroethylene (PTFE) bypass grafting.

Procedure: Polytetrafluoroethylene (PTFE) bypass grafting.

Group II

EXPERIMENTAL

Intervention: Autogenous vein bypass grafting.

Procedure: Autogenous vein bypass grafting

Interventions

Polytetrafluoroethylene (PTFE) bypass grafting. PROCEDURE

Polytetrafluoroethylene (PTFE) bypass grafting. Patients will undergo bypass procedure using PTFE graft : the inflow vessel may be the femoral artery or the iliac artery; the outflow vessel may be the popliteal artery or the anterior tibial artery.

Group I

Autogenous vein bypass grafting PROCEDURE

Autogenous vein bypass grafting. Patients will undergo Bypass procedure using autogenous veins (the great saphenous vein or the small saphenous vein or a composite bypass using great and small saphenous vein ). The inflow vessel may be represented by the femoral artery or the popliteal artery; the outflow vessel may be the anterior tibial artery or the posterior tibial artery or the peroneal artery.

Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with CLI stage III-IV according to the Fontaine's classification

You may not qualify if:

• Patients with evidence of systemic sepsis, known neoplastic disease or any established generalized inflammatory disease

Sponsors & Collaborators

• University of Catanzaro: lead

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Polytetrafluoroethylene

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Fluorocarbon Polymers; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Raffaele Serra

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 17, 2015
• Study Start: January 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 17, 2015

Record last verified: 2015-03