Clinical trial NCT03057080: The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing
Official title: Peripheral Angioplasty as the First Choice Revascularization Procedure to Promote Ischemic Leg Ulcer Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Foot Ulcers
Lead sponsor: University of Crete
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of patients with ulcer healing
timeFrame: 2 years
Secondary outcomes:
measure: Amputation free survival
timeFrame: 2 years
measure: Number of patients with all-cause mortality
timeFrame: 2 years
measure: Number of participants with Major adverse events
timeFrame: 2 years
measure: Number of patients with 30-day morbidity and mortality
timeFrame: 30 days
measure: Number of patients requiring re-intervention
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Crete
name: Dimitrios Tsetis, MD, PhD
role: STUDY_CHAIR
References: