Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone

NCT ID: NCT00731835

Last Updated: 2016-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-09-30

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 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.

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. 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.

Conditions

Ischemic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I

1\. Wound Care (group 1)--Best standard wound care with aggressive debridement

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group 2

2. Endovascular Intervention + Wound Care (group 2)--Best standard wound care in combination with endovascular revascularization

Endovascular revascularization is the intervention

Group Type: ACTIVE_COMPARATOR

Endovascular Revascularization

Intervention Type: PROCEDURE

• angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or
• stent placement
• atherectomy

Interventions

Endovascular Revascularization

• angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or
• stent placement
• atherectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Society for Vascular Surgery

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Rabih A. Chaer

Associate Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

Protocol #2, Version 1

Identifier Type: -

Identifier Source: org_study_id