Peripheral Angioplasty as the First Choice Revascularization Procedure to Promote Ischemic Leg Ulcer Healing
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Foot Ulcers
- Sponsor
- University of Crete
- Enrollment
- 161
- Primary Endpoint
- Number of patients with ulcer healing
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Izolde Bouloukaki
MD, PhD
University of Crete
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
Outcomes
Primary Outcomes
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
- Number of participants with Major adverse events(2 years)
- Amputation free survival(2 years)
- Number of patients with 30-day morbidity and mortality(30 days)
- Number of patients requiring re-intervention(2 years)
- Number of patients with all-cause mortality(2 years)