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The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

NCT03057080 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2017-02-17

No results posted yet for this study

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.

Conditions

  • Ischemic Foot Ulcers

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • University of Crete

    lead OTHER

Principal Investigators

  • Dimitrios Tsetis, MD, PhD · University of Crete

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-01
Primary Completion
2015-06-01
Completion
2016-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03057080 on ClinicalTrials.gov