The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

Study Overview
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Brief Summary
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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
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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.

Official Title
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Peripheral Angioplasty as the First Choice Revascularization Procedure to Promote Ischemic Leg Ulcer Healing

Conditions
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Ischemic Foot Ulcers

Intervention / Treatment
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* Procedure: Percutaneous transluminal angioplasty (PTA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PTA procedure<br>Percutaneous transluminal angioplasty (PTA) in patients with ischemic leg ulcer | Procedure: Percutaneous transluminal angioplasty (PTA)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with ulcer healing | Number of patients with complete Ischemic leg ulcer healing defined as the complete epithelization of the lesion | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation free survival | Number of months without amputation | 2 years | 
| Number of patients with all-cause mortality | Number of patients with all-cause mortality after PTA | 2 years | 
| Number of participants with Major adverse events | Number of participants with Major adverse events from PTA | 2 years | 
| Number of patients with 30-day morbidity and mortality | 30-day morbidity and mortality from PTA | 30 days | 
| Number of patients requiring re-intervention | umber of patients requiring PTA re-intervention | 2 years |