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The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

Primary Purpose

Ischemic Foot Ulcers

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous transluminal angioplasty (PTA)
Sponsored by
University of Crete
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Foot Ulcers

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • newly diagnosed patients with ischemic foot ulcer and
  • patients aged 18 years or older.

Exclusion Criteria:

  • refusal to participate
  • refusal of PTA therapy
  • lesions not amenable to endovascular revascularization by vascular team's consensus based on preinterventional imaging
  • absolute contraindication to contrast media injection, as determined by the investigator
  • uncontrollable coagulopathy
  • unwilling or unable to provide informed consent or return for required follow-up evaluations and
  • previous or concurrent participation in another clinical research study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    PTA procedure

    Arm Description

    Percutaneous transluminal angioplasty (PTA) in patients with ischemic leg ulcer

    Outcomes

    Primary Outcome Measures

    Number of patients with ulcer healing
    Number of patients with complete Ischemic leg ulcer healing defined as the complete epithelization of the lesion

    Secondary Outcome Measures

    Amputation free survival
    Number of months without amputation
    Number of patients with all-cause mortality
    Number of patients with all-cause mortality after PTA
    Number of participants with Major adverse events
    Number of participants with Major adverse events from PTA
    Number of patients with 30-day morbidity and mortality
    30-day morbidity and mortality from PTA
    Number of patients requiring re-intervention
    umber of patients requiring PTA re-intervention

    Full Information

    First Posted
    February 12, 2017
    Last Updated
    February 14, 2017
    Sponsor
    University of Crete
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03057080
    Brief Title
    The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing
    Official Title
    Peripheral Angioplasty as the First Choice Revascularization Procedure to Promote Ischemic Leg Ulcer Healing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2009 (Actual)
    Primary Completion Date
    June 1, 2015 (Actual)
    Study Completion Date
    December 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Crete

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the management of ischemic foot ulcers. All consecutive patients presenting with a foot ulcer at the outpatient Vascular surgery clinic of our hospital were evaluated. If non-invasive parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was performed and a PTA was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short-term and long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients with worsening ulcers after PTA underwent bypass grafting or amputation.
    Detailed Description
    The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the management of ischemic foot ulcers. Methods: All consecutive patients presenting with a foot ulcer at the outpatient Vascular surgery clinic of our hospital were evaluated. Preoperative evaluation included foot pulse assessment, ankle-brachial-index (ABI) and duplex scanning. If non-invasive parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was performed and a PTA was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short-term and long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients with worsening ulcers after PTA underwent bypass grafting or amputation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Foot Ulcers

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    161 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PTA procedure
    Arm Type
    Other
    Arm Description
    Percutaneous transluminal angioplasty (PTA) in patients with ischemic leg ulcer
    Intervention Type
    Procedure
    Intervention Name(s)
    Percutaneous transluminal angioplasty (PTA)
    Intervention Description
    The main goal of the angioplasty (which was also the definition of technical success) was to achieve straight-line flow (SLF) from the aorta down to either a patent dorsalis pedis or plantar arch.
    Primary Outcome Measure Information:
    Title
    Number of patients with ulcer healing
    Description
    Number of patients with complete Ischemic leg ulcer healing defined as the complete epithelization of the lesion
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Amputation free survival
    Description
    Number of months without amputation
    Time Frame
    2 years
    Title
    Number of patients with all-cause mortality
    Description
    Number of patients with all-cause mortality after PTA
    Time Frame
    2 years
    Title
    Number of participants with Major adverse events
    Description
    Number of participants with Major adverse events from PTA
    Time Frame
    2 years
    Title
    Number of patients with 30-day morbidity and mortality
    Description
    30-day morbidity and mortality from PTA
    Time Frame
    30 days
    Title
    Number of patients requiring re-intervention
    Description
    umber of patients requiring PTA re-intervention
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: newly diagnosed patients with ischemic foot ulcer and patients aged 18 years or older. Exclusion Criteria: refusal to participate refusal of PTA therapy lesions not amenable to endovascular revascularization by vascular team's consensus based on preinterventional imaging absolute contraindication to contrast media injection, as determined by the investigator uncontrollable coagulopathy unwilling or unable to provide informed consent or return for required follow-up evaluations and previous or concurrent participation in another clinical research study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dimitrios Tsetis, MD, PhD
    Organizational Affiliation
    University of Crete
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

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