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OpenTrials
Completed

NCT Number: NCT03057080

The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous transluminal angioplasty (PTA)

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.

Primary outcomes

  1. Number of patients with ulcer healing

    Time frame: 2 years

    Number of patients with complete Ischemic leg ulcer healing defined as the complete epithelization of the lesion

Secondary outcomes

  1. Amputation free survival

    Time frame: 2 years

    Number of months without amputation

  2. Number of patients with all-cause mortality

    Time frame: 2 years

    Number of patients with all-cause mortality after PTA

  3. Number of participants with Major adverse events

    Time frame: 2 years

    Number of participants with Major adverse events from PTA

  4. Number of patients with 30-day morbidity and mortality

    Time frame: 30 days

    30-day morbidity and mortality from PTA

  5. Number of patients requiring re-intervention

    Time frame: 2 years

    umber of patients requiring PTA re-intervention

Sponsors and collaborators

Lead sponsor

University of Crete

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2016
First posted
Feb 17, 2017
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.