Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone

Stopped early · Not applicable

Conditions studied: Ischemic Foot Ulcer

In brief

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 modalities for the management of ischemic foot ulcers. The ischemic foot ulcer (wound) on your foot is a result of a blocked artery in your leg. The wound can sometimes be healed with wound care alone, which includes dressing changes with creams and removing (debriding) the dead tissue. Alternatively, the significant narrowing or blockage in one of the arteries in your leg can be treated with several endovascular treatment techniques including: * angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or * stent placement * atherectomy The hypothesis of this study is that early endovascular or surgical intervention in subjects with moderate arterial insufficiency and a non-healing foot ulcer results in a higher overall incidence of wound healing in a significantly shorter period of time.

Key facts

Study ID

NCT00731835

Run by

University of Pittsburgh

People needed

4

Starts

2008-07-01

Expected to finish

2011-09-01

Last updated by the study team

2016-03-11

Who can join

Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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