Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone
| Status: | Terminated |
|---|---|
| Conditions: | Peripheral Vascular Disease, Gastrointestinal, Podiatry |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 110 |
| Updated: | 4/21/2016 |
| Start Date: | July 2008 |
| End Date: | September 2011 |
Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone? A Randomized Controlled Trial
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.
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.
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. The study population will be comprised of subjects with a foot ulcer and
non-palpable or diminished pedal pulses. The expected duration of subjects in this trial is
2 years.
Patients will be randomized into two groups:
1. Wound Care (group 1)--Best standard wound care with aggressive debridement
2. Endovascular Intervention + Wound Care (group 2)--Best standard wound care in
combination with endovascular revascularization
Subjects will undergo standard of care evaluation for ischemic foot ulcers. These same
evaluations would be performed whether or not the subject was participating in this research
study. In the event that a clinically significant event or unanticipated disease or
condition is identified, the subject and their doctor will be notified, the investigator,
will review the results of the tests and procedures that are standard of care, and the
results will become part of the research record. Prior to undergoing randomization, the
subject will sign and fully understand an IRB consent form that is HIPAA compliant.
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. The study population will be comprised of subjects with a foot ulcer and
non-palpable or diminished pedal pulses. The expected duration of subjects in this trial is
2 years.
Patients will be randomized into two groups:
1. Wound Care (group 1)--Best standard wound care with aggressive debridement
2. Endovascular Intervention + Wound Care (group 2)--Best standard wound care in
combination with endovascular revascularization
Subjects will undergo standard of care evaluation for ischemic foot ulcers. These same
evaluations would be performed whether or not the subject was participating in this research
study. In the event that a clinically significant event or unanticipated disease or
condition is identified, the subject and their doctor will be notified, the investigator,
will review the results of the tests and procedures that are standard of care, and the
results will become part of the research record. Prior to undergoing randomization, the
subject will sign and fully understand an IRB consent form that is HIPAA compliant.
Inclusion Criteria:
- 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 Criteria:
- 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
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