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
About this trial
This is an interventional treatment trial for Ischemic Foot Ulcers
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
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
NCT ID
NCT03057080
First Posted
February 12, 2017
Last Updated
February 14, 2017
Sponsor
University of Crete
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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