THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease
Peripheral Arterial Disease, Claudication, Claudication, Intermittent
About this trial
This is an interventional other trial for Peripheral Arterial Disease focused on measuring peripheral arterial disease, claudication, PAD, Vascular Disease, Vascular Occlusion, Vacular Calcification, intermittent claudication, Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
Healthy Volunteers:
-Age 20-80
PAD Patients:
- Mild claudication to rest pain (Rutherford 1-4)
- Resting or exercise ABI < 0.9 or TBI < 0.6
- Age 40 and more
OA Patients:
-Lower extremity (hip or knee) OA
Exclusion Criteria:
PAD, OA Patients and Healthy Volunteers:
- Plan to undergo surgical procedure or PVI for treatment of PAD within one month
- Evidence of active infection
- Hypersensitivity or allergy to fish or seafood
- Already on n-3 PUFA or equivalent
- Chronic liver disease, end-stage renal disease (CKD 5), or chronic inflammatory disorders
- Poorly controlled diabetes (HbA1C > 8%)
- BMI < 20 or >35
- Recent other major surgery or illness within 30 days
- Use of immunosuppressive medications or steroids
- History of organ transplantation
- Pregnancy, or plans to become pregnant, or lactating
Healthy Volunteers:
- hsCRP > 2mg/L
- Regular aspirin use
- Regular non-steroidal anti-inflammatory drug use
Sites / Locations
- University of California San Francisco
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
Phase 1a (OMEGA-SPM-DOSE)
SPM - Phase 1b (OMEGA-SPM-DOSE)
Placebo - Phase 1b (OMEGA-SPM-PLACEBO)
PAD patients and healthy volunteers in study for SPM Emulsion, dose-modality.
PAD and Osteoarthritis (OA) patients using softgel, dose-modality.
PAD and Osteoarthritis (OA) patients using softgel, dose-modality.