Status:
TERMINATED
Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Society for Vascular Surgery
Conditions:
Ischemic Foot Ulcer
Eligibility:
All Genders
18-110 years
Phase:
NA
Brief Summary
You are being asked to take part in this study because your doctor has determined that you have an ischemic foot ulcer. This research study will compare two approved standard of care treatment modalit...
Detailed Description
Design: This study is a single center, prospective, randomized trial evaluating the benefit of endovascular intervention on the healing of ischemic foot ulcers when compared to best wound care alone....
Eligibility Criteria
Inclusion
- The subject (male or non-pregnant female) must be greater than or equal to 18 years of age
- Ischemic ulcer of foot present
- An ankle-brachial index (ABI) of 0.4 to 0.8 or monophasic-biphasic waveforms on pulse volume recordings. (If the subject is diabetic or has renal failure, with incompressible vessels, a toe brachial index of 0.4 to 0.8 is required.)
- Signed informed consent
Exclusion
- Severe ischemia as defined by advanced gangrene, an ABI of less then or equal to 0.3 and monophasic waveforms on pulse volume recording
- Advanced renal insufficiency, defined as serum creatinine greater than or equal to 3 mg/dl
- Absolute contraindication to contrast media, as determined by the investigator
- Unwilling or unable to provide informed consent or return for required follow-up evaluations.
- Previous enrollment in this clinical study
- Concurrent participation in another clinical research study
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00731835
Start Date
July 1 2008
End Date
September 1 2011
Last Update
March 11 2016
Active Locations (1)
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1
UPMC
Pittsburgh, Pennsylvania, United States, 15232