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Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone

NCT00731835 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2016-03-11

No results posted yet for this study

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.

Conditions

  • Ischemic Foot Ulcer

Interventions

PROCEDURE

Endovascular Revascularization

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

Sponsors & Collaborators

  • Society for Vascular Surgery

    collaborator OTHER

  • University of Pittsburgh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00731835 on ClinicalTrials.gov