NCT01297387

Brief Summary

This observational prospective study will evaluate, according o usual local clinical practice, feasibility of endoluminal revascularization in diabetic patients with type C and D lesions, according to TASC II Criteria. About 300 patients will be treated with usual revascularization procedure. Each patient will be followed at least 12 months to evaluate clinical outcome and limb salvage interventions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
Last Updated

February 21, 2011

Status Verified

February 1, 2011

First QC Date

February 15, 2011

Last Update Submit

February 18, 2011

Conditions

DiabetesCritical Limb Ischemia

Keywords

Diabetic PatientsCritical Limb IschemiaRevascularization

Study Arms (1)

Revascularization of limb ischemia

Procedure/Surgery

Other: PTA BPG procedure,

Interventions

PTA BPG procedure,OTHER

Surgery PTA or BPG Procedure, according usual local clinical practice

Also known as: Peripheral angioplasty
Revascularization of limb ischemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diabetic patients with critical limb ischemia

You may qualify if:

  • Adult diabetic patients type 1 or 2
  • Chronic critical ischemia as defined by TASC 2007 criteria (pain at rest, and/or ulcer or gangrene due to arteriopathy: transcutaneous oximetry \< 30 mmHg or pressure on the ankle \< 70 mmHg)

You may not qualify if:

  • Cancer with adverse prognosis in months, or chemotherapeutic treatment
  • Ongoing or planned pregnancy
  • Lack of consent to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetic Foot Center IRCCS MultiMedica

Sesto San Giovanni, Milano, 20099, Italy

Location

MeSH Terms

Conditions

Diabetes MellitusChronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Officials

  • Ezio Faglia, MD

    Diabetic Foot Centre IRCCS MultiMedica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 16, 2011

Study Start

January 1, 2009

Study Completion

December 1, 2009

Last Updated

February 21, 2011

Record last verified: 2011-02

Locations

IT(1)