Determining the presence and significance of atherosclerotic plaque-associated biofilms in peripheral arterial disease
M
Mithun Sinha
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
N/A
398 participants needed
5 Locations
Brief description of study
What is the purpose of this study?
This study will examine the relationship between bacteria and biofilms in tibial arteries and lower limb tissue and patient characteristics in a population with critical limb threatening ischemia (CLTI), who have undergone lower extremity amputation. The study will analyze tissue samples from amputation specimens to identify the presence of biofilms in atherosclerotic plaques or arteries in patients with CLTI to identify the presence of bacteria or biofilms in lower limb tissue and to identify the causative bacteria from the samples collective.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Patients will be identified by one of the physicians on the study in the inpatient or outpatient clinic as needing a major limb amputation. The physician will then refer that subject to the study team, and the study team will contact the potential subject either in clinic or during the pre-operative setting. The IU clinical locations will be sites for subject recruitment, enrollment and conducting study activities.
Detailed description of study
What will happen during the study?
- This is a descriptive single-arm study which will consist of 1 study visit at enrollment, during the pre-operative informed consent process.
- The study will have a single visit that will take place alongside the patient's normal pre-operative informed consent process.
- Surgery: Patients will be undergoing lower extremity limb amputation. The risks of this surgery include risks of bleeding, infection, chronic wounds, or need for re-intervention. These risks are unavoidable as part of the surgical treatment. All operations will be performed by trained surgeons at the specified sites.
- Tissue Collection: Tissue from the amputation specimen will be collected for laboratory analysis. At the time of amputation the following tissues from the amputation specimen will be collected: wound tissue and skin, unwounded skin, arteries, blood (optional).
- Blood Draw: Patients will have routine laboratory testing performed as part of their medical care. Temporary discomfort from the needle stick, bruising, bleeding, and rarely, infection. These samples are drawn by trained inpatient nursing staff.
- The presence of biofilms in atherosclerotic plaques from arteries found in lower extremity amputation specimens will be studied.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Peripheral Arterial Atherosclerotic Disease, PAD
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria
1. Male or Female, Age ≥ 18.
2. Subject can read and understand English.
3. Clinically diagnosed with peripheral arterial atherosclerotic disease.
4. Subject with chronic limb threatening ischemia that is scheduled for lower extremity amputation surgery.
Exclusion Criteria
1. Individuals who are deemed unable to understand the procedures, risks, and benefits of the study.
2. Subjects with marked immunodeficiency (HIV/AIDS, or on immunosuppressive medications).
3. Pregnant women
4. Prisoners
1. Male or Female, Age ≥ 18.
2. Subject can read and understand English.
3. Clinically diagnosed with peripheral arterial atherosclerotic disease.
4. Subject with chronic limb threatening ischemia that is scheduled for lower extremity amputation surgery.
Exclusion Criteria
1. Individuals who are deemed unable to understand the procedures, risks, and benefits of the study.
2. Subjects with marked immunodeficiency (HIV/AIDS, or on immunosuppressive medications).
3. Pregnant women
4. Prisoners
Updated on
23 Apr 2025.
Study ID: SURG-IIR-PAD, 23953
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