The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

Not Applicable

Completed

• Conditions: Ischemic Foot Ulcers
• Interventions: Procedure: Percutaneous transluminal angioplasty (PTA)

• Registration Number: NCT03057080
• Lead Sponsor: University of Crete

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.

Study Timeline

• Study Start: 2009-06-01
• Primary Completion: 2015-06-01
• Study Completion: 2016-12-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-12
• Study First Submitted QC: 2017-02-14
• Last Update Submitted: 2017-02-14
• Study First Posted: 2017-02-17
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PTA procedure	Percutaneous transluminal angioplasty (PTA)	Percutaneous transluminal angioplasty (PTA) in patients with ischemic leg ulcer

Primary Outcome Measures

Name	Time	Method
Number of patients with ulcer healing	2 years	Number of patients with complete Ischemic leg ulcer healing defined as the complete epithelization of the lesion

Secondary Outcome Measures

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