Ischemic Foot Ulcers Clinical Trial
Official title:
Peripheral Angioplasty as the First Choice Revascularization Procedure to Promote Ischemic Leg Ulcer Healing
| Verified date | February 2017 |
| Source | University of Crete |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 161 |
| Est. completion date | December 1, 2016 |
| Est. primary completion date | June 1, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Crete |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients with ulcer healing | Number of patients with complete Ischemic leg ulcer healing defined as the complete epithelization of the lesion | 2 years | |
| Secondary | Amputation free survival | Number of months without amputation | 2 years | |
| Secondary | Number of patients with all-cause mortality | Number of patients with all-cause mortality after PTA | 2 years | |
| Secondary | Number of participants with Major adverse events | Number of participants with Major adverse events from PTA | 2 years | |
| Secondary | Number of patients with 30-day morbidity and mortality | 30-day morbidity and mortality from PTA | 30 days | |
| Secondary | Number of patients requiring re-intervention | umber of patients requiring PTA re-intervention | 2 years |