The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

NCT ID: NCT03057080

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-01
• Study Completion Date: 2016-12-01

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.

Conditions

Ischemic Foot Ulcers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PTA procedure

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

Group Type: OTHER

Percutaneous transluminal angioplasty (PTA)

Intervention Type: PROCEDURE

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.

Interventions

Percutaneous transluminal angioplasty (PTA)

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Crete

OTHER

Sponsor Role: lead

Responsible Party

Izolde Bouloukaki

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dimitrios Tsetis, MD, PhD

Role: STUDY_CHAIR

University of Crete

Other Identifiers

PTA1A

Identifier Type: -

Identifier Source: org_study_id