Peripheral Arterial DiseaseNCT02719665
THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease
A study testing SPM Emulsion, Dose-modality and SPM Softgel, Dose-Modality in people with Peripheral Arterial Disease and Claudication, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to understand the effects of fish oil supplement (containing parts of omega-3 fatty acids) on inflammation. The investigators are aiming to identify which dose of the fish oil supplement is the most effective. The name of the fish oil supplement is "SPM Emulsion." Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease, Claudication, Claudication, Intermittent
- What is being tested?
- SPM Emulsion, Dose-modality and SPM Softgel, Dose-Modality
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
The purpose of this study is to understand the effects of fish oil supplement (containing parts of omega-3 fatty acids) on inflammation. The investigators are aiming to identify which dose of the fish oil supplement is the most effective. The name of the fish oil supplement is "SPM Emulsion."
Read the detailed description
The OMEGA-SPM-DOSE trial and the OMEGA-SPM-PAD trial are two parts of a pilot study which aims to investigate the effect of a novel formulation of a nutritional supplement containing highly concentrated n-3 PUFA metabolites (SPM Emulsion) on the metabolo-lipidomic profile of healthy volunteers and patients with Peripheral Arterial Disease(PAD). Ten healthy volunteers and ten patients with PAD will participate in Part 1a, the "OMEGA-SPM-DOSE Study". A follow-up, placebo controlled, prospective study on the best dosing modality determined in Phase 1a will then take place in a PAD and OA population (n=12), Phase 1b - the "OMEGA-SPM-PAD Study". Specific measurements will include targeted metabolo-lipidomic profiling, established markers of inflammation, and functional monocyte and macrophage assays. The proposed studies have the potential to provide important new insights on the role of nutritional interventions in PAD.
- Conditions
- Peripheral Arterial Disease, Claudication, Claudication, Intermittent, Vascular Occlusion, Vascular Calcification, Vascular Diseases
- Being tested
- SPM Emulsion, Dose-modality, SPM Softgel, Dose-Modality, Placebo Softgel
- Keywords
- peripheral arterial disease, claudication, PAD, Vascular Disease, Vascular Occlusion, Vacular Calcification, intermittent claudication, Osteoarthritis
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Vascular Calcification, Vascular Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPM Emulsion, Dose-modalityDietary supplement
Also called Omega SPM, Specialized Pro-resolving Lipid Mediator Emulsion
Phase 1a Dose-Finding oral SPM administration of increasing dose (15ml, 30ml, and 60ml) by the following schedule:
Days 1 to 5: 15 ml; Days 6 to 14: Washout, no SPM administration; Days 15 to 19: 30 ml; Days 20-28: Washout, no SPM administration; Days 29-33: 60 ml
SPM Softgel, Dose-ModalityDietary supplement
Also called Omega SPM Bridging
Phase 1b Dose-Finding oral softtel SPM administration of two different doses (2 softgel vs 4 softgel) Days 0 to 5: 2 SPM softgel; Days 6 to 21: Washout, no SPM administration; Days 22 to 26: 4 SPM softgel; Days 27-42: Washout, no SPM administration
Placebo SoftgelDietary supplement
Also called Omega SPM Bridging
Days 43-47: 4 Placebo softgel; Day 48-64 Washout
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a (OMEGA-SPM-DOSE) | Experimental | PAD patients and healthy volunteers in study for SPM Emulsion, dose-modality. Receives: Dietary Supplement: SPM Emulsion, Dose-modality |
| SPM - Phase 1b (OMEGA-SPM-DOSE) | Active comparator | PAD and Osteoarthritis (OA) patients using softgel, dose-modality. Receives: Dietary Supplement: SPM Softgel, Dose-Modality |
| Placebo - Phase 1b (OMEGA-SPM-PLACEBO) | Placebo comparator | PAD and Osteoarthritis (OA) patients using softgel, dose-modality. Receives: Dietary Supplement: Placebo Softgel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Phase 1b Dose
The smallest dose administered in Phase 1a participants which results in an increase in Resolution Index at least 3 times that of baseline, or the subsequent larger dose resulting in a Resolution Index greater than 2 times that of the preceding does with no increase in side effects at the larger dose.
Measured: Baseline, Day 33
Change in the Resolution Index
Integrated metabolo-lipidomics assessment of SPM pathways: Average concentration of 15-HEPE, 18-HEPE, 4-HDHA, and 17-HDHA in plasma.
Measured: Baseline, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Conte, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719665
- Sponsor's protocol ID
- 15-17371
- Status last verified
- May 2021
- First submitted
- 21 Mar 2016
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grenon SM, Owens CD, Nosova EV, Hughes-Fulford M, Alley HF, Chong K, Perez S, Yen PK, Boscardin J, Hellmann J, Spite M, Conte MS. Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial). J Am Heart Assoc. 2015 Aug 21;4(8):e002034. doi: 10.1161/JAHA.115.002034.
PubMed 26296857Grenon SM, Owens CD, Alley H, Chong K, Yen PK, Harris W, Hughes-Fulford M, Conte MS. n-3 Polyunsaturated fatty acids supplementation in peripheral artery disease: the OMEGA-PAD trial. Vasc Med. 2013 Oct;18(5):263-74. doi: 10.1177/1358863X13503695. Epub 2013 Sep 19.
PubMed 24052491Akagi D, Chen M, Toy R, Chatterjee A, Conte MS. Systemic delivery of proresolving lipid mediators resolvin D2 and maresin 1 attenuates intimal hyperplasia in mice. FASEB J. 2015 Jun;29(6):2504-13. doi: 10.1096/fj.14-265363. Epub 2015 Mar 16.
PubMed 25777995Chatterjee A, Sharma A, Chen M, Toy R, Mottola G, Conte MS. The pro-resolving lipid mediator maresin 1 (MaR1) attenuates inflammatory signaling pathways in vascular smooth muscle and endothelial cells. PLoS One. 2014 Nov 19;9(11):e113480. doi: 10.1371/journal.pone.0113480. eCollection 2014.
PubMed 25409514Miyahara T, Runge S, Chatterjee A, Chen M, Mottola G, Fitzgerald JM, Serhan CN, Conte MS. D-series resolvin attenuates vascular smooth muscle cell activation and neointimal hyperplasia following vascular injury. FASEB J. 2013 Jun;27(6):2220-32. doi: 10.1096/fj.12-225615. Epub 2013 Feb 13.
PubMed 23407709Hudert CA, Weylandt KH, Lu Y, Wang J, Hong S, Dignass A, Serhan CN, Kang JX. Transgenic mice rich in endogenous omega-3 fatty acids are protected from colitis. Proc Natl Acad Sci U S A. 2006 Jul 25;103(30):11276-81. doi: 10.1073/pnas.0601280103. Epub 2006 Jul 17.
PubMed 16847262Recchiuti A, Codagnone M, Pierdomenico AM, Rossi C, Mari VC, Cianci E, Simiele F, Gatta V, Romano M. Immunoresolving actions of oral resolvin D1 include selective regulation of the transcription machinery in resolution-phase mouse macrophages. FASEB J. 2014 Jul;28(7):3090-102. doi: 10.1096/fj.13-248393. Epub 2014 Apr 1.
PubMed 24692596Wang X, Hjorth E, Vedin I, Eriksdotter M, Freund-Levi Y, Wahlund LO, Cederholm T, Palmblad J, Schultzberg M. Effects of n-3 FA supplementation on the release of proresolving lipid mediators by blood mononuclear cells: the OmegAD study. J Lipid Res. 2015 Mar;56(3):674-681. doi: 10.1194/jlr.P055418. Epub 2015 Jan 23.
PubMed 25616438Chiang N, Fredman G, Backhed F, Oh SF, Vickery T, Schmidt BA, Serhan CN. Infection regulates pro-resolving mediators that lower antibiotic requirements. Nature. 2012 Apr 25;484(7395):524-8. doi: 10.1038/nature11042.
PubMed 22538616Mizwicki MT, Liu G, Fiala M, Magpantay L, Sayre J, Siani A, Mahanian M, Weitzman R, Hayden EY, Rosenthal MJ, Nemere I, Ringman J, Teplow DB. 1alpha,25-dihydroxyvitamin D3 and resolvin D1 retune the balance between amyloid-beta phagocytosis and inflammation in Alzheimer's disease patients. J Alzheimers Dis. 2013;34(1):155-70. doi: 10.3233/JAD-121735.
PubMed 23186989Oh SF, Pillai PS, Recchiuti A, Yang R, Serhan CN. Pro-resolving actions and stereoselective biosynthesis of 18S E-series resolvins in human leukocytes and murine inflammation. J Clin Invest. 2011 Feb;121(2):569-81. doi: 10.1172/JCI42545. Epub 2011 Jan 4.
PubMed 21206090Serhan CN, Yang R, Martinod K, Kasuga K, Pillai PS, Porter TF, Oh SF, Spite M. Maresins: novel macrophage mediators with potent antiinflammatory and proresolving actions. J Exp Med. 2009 Jan 16;206(1):15-23. doi: 10.1084/jem.20081880. Epub 2008 Dec 22.
PubMed 19103881Serhan CN. Resolution phase of inflammation: novel endogenous anti-inflammatory and proresolving lipid mediators and pathways. Annu Rev Immunol. 2007;25:101-37. doi: 10.1146/annurev.immunol.25.022106.141647.
PubMed 17090225Serhan CN. Pro-resolving lipid mediators are leads for resolution physiology. Nature. 2014 Jun 5;510(7503):92-101. doi: 10.1038/nature13479.
PubMed 24899309Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
PubMed 9887164
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT02719665
- Acronym / sponsor ID
- 15-17371
- Conditions
- Peripheral Arterial Disease, Claudication, Claudication, Intermittent, Vascular Occlusion, Vascular Calcification, Vascular Diseases
- Keywords
- peripheral arterial disease, claudication, PAD, Vascular Disease, Vascular Occlusion, Vacular Calcification, intermittent claudication, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand the effects of fish oil supplement (containing parts of omega-3 fatty acids) on inflammation. The investigators are aiming to identify which dose of the fish oil supplement is the most effective. The name of the fish oil supplement is "SPM Emulsion."
Detailed description
The OMEGA-SPM-DOSE trial and the OMEGA-SPM-PAD trial are two parts of a pilot study which aims to investigate the effect of a novel formulation of a nutritional supplement containing highly concentrated n-3 PUFA metabolites (SPM Emulsion) on the metabolo-lipidomic profile of healthy volunteers and patients with Peripheral Arterial Disease(PAD). Ten healthy volunteers and ten patients with PAD will participate in Part 1a, the "OMEGA-SPM-DOSE Study". A follow-up, placebo controlled, prospective study on the best dosing modality determined in Phase 1a will then take place in a PAD and OA population (n=12), Phase 1b - the "OMEGA-SPM-PAD Study". Specific measurements will include targeted metabolo-lipidomic profiling, established markers of inflammation, and functional monocyte and macrophage assays. The proposed studies have the potential to provide important new insights on the role of nutritional interventions in PAD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a (OMEGA-SPM-DOSE) | Experimental | Dietary Supplement: SPM Emulsion, Dose-modalityPAD patients and healthy volunteers in study for SPM Emulsion, dose-modality. |
| SPM - Phase 1b (OMEGA-SPM-DOSE) | Active comparator | Dietary Supplement: SPM Softgel, Dose-ModalityPAD and Osteoarthritis (OA) patients using softgel, dose-modality. |
| Placebo - Phase 1b (OMEGA-SPM-PLACEBO) | Placebo comparator | Dietary Supplement: Placebo SoftgelPAD and Osteoarthritis (OA) patients using softgel, dose-modality. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- -Age 20-80
- Mild claudication to rest pain (Rutherford 1-4)
- Resting or exercise ABI < 0.9 or TBI < 0.6
- Age 40 and more
- -Lower extremity (hip or knee) OA
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPM Emulsion, Dose-modalityAlso: Omega SPM, Specialized Pro-resolving Lipid Mediator EmulsionPhase 1a Dose-Finding oral SPM administration of increasing dose (15ml, 30ml, and 60ml) by the following schedule: Days 1 to 5: 15 ml; Days 6 to 14: Washout, no SPM administration; Days 15 to 19: 30 ml; Days 20-28: Washout, no SPM administration; Days 29-33: 60 ml | Dietary supplement | Phase 1a (OMEGA-SPM-DOSE) |
| SPM Softgel, Dose-ModalityAlso: Omega SPM BridgingPhase 1b Dose-Finding oral softtel SPM administration of two different doses (2 softgel vs 4 softgel) Days 0 to 5: 2 SPM softgel; Days 6 to 21: Washout, no SPM administration; Days 22 to 26: 4 SPM softgel; Days 27-42: Washout, no SPM administration | Dietary supplement | SPM - Phase 1b (OMEGA-SPM-DOSE) |
| Placebo SoftgelAlso: Omega SPM BridgingDays 43-47: 4 Placebo softgel; Day 48-64 Washout | Dietary supplement | Placebo - Phase 1b (OMEGA-SPM-PLACEBO) |
Primary outcome
Optimal Phase 1b Dose
Time frame: Baseline, Day 33
The smallest dose administered in Phase 1a participants which results in an increase in Resolution Index at least 3 times that of baseline, or the subsequent larger dose resulting in a Resolution Index greater than 2 times that of the preceding does with no increase in side effects at the larger dose.
Change in the Resolution Index
Time frame: Baseline, Day 5
Integrated metabolo-lipidomics assessment of SPM pathways: Average concentration of 15-HEPE, 18-HEPE, 4-HDHA, and 17-HDHA in plasma.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Background: PubMed 26296857Grenon SM, Owens CD, Nosova EV, Hughes-Fulford M, Alley HF, Chong K, Perez S, Yen PK, Boscardin J, Hellmann J, Spite M, Conte MS. Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial). J Am Heart Assoc. 2015 Aug 21;4(8):e002034. doi: 10.1161/JAHA.115.002034.
- Background: PubMed 24052491Grenon SM, Owens CD, Alley H, Chong K, Yen PK, Harris W, Hughes-Fulford M, Conte MS. n-3 Polyunsaturated fatty acids supplementation in peripheral artery disease: the OMEGA-PAD trial. Vasc Med. 2013 Oct;18(5):263-74. doi: 10.1177/1358863X13503695. Epub 2013 Sep 19.
- Background: PubMed 25777995Akagi D, Chen M, Toy R, Chatterjee A, Conte MS. Systemic delivery of proresolving lipid mediators resolvin D2 and maresin 1 attenuates intimal hyperplasia in mice. FASEB J. 2015 Jun;29(6):2504-13. doi: 10.1096/fj.14-265363. Epub 2015 Mar 16.
- Background: PubMed 25409514Chatterjee A, Sharma A, Chen M, Toy R, Mottola G, Conte MS. The pro-resolving lipid mediator maresin 1 (MaR1) attenuates inflammatory signaling pathways in vascular smooth muscle and endothelial cells. PLoS One. 2014 Nov 19;9(11):e113480. doi: 10.1371/journal.pone.0113480. eCollection 2014.
- Background: PubMed 23407709Miyahara T, Runge S, Chatterjee A, Chen M, Mottola G, Fitzgerald JM, Serhan CN, Conte MS. D-series resolvin attenuates vascular smooth muscle cell activation and neointimal hyperplasia following vascular injury. FASEB J. 2013 Jun;27(6):2220-32. doi: 10.1096/fj.12-225615. Epub 2013 Feb 13.
- Background: PubMed 16847262Hudert CA, Weylandt KH, Lu Y, Wang J, Hong S, Dignass A, Serhan CN, Kang JX. Transgenic mice rich in endogenous omega-3 fatty acids are protected from colitis. Proc Natl Acad Sci U S A. 2006 Jul 25;103(30):11276-81. doi: 10.1073/pnas.0601280103. Epub 2006 Jul 17.
- Background: PubMed 24692596Recchiuti A, Codagnone M, Pierdomenico AM, Rossi C, Mari VC, Cianci E, Simiele F, Gatta V, Romano M. Immunoresolving actions of oral resolvin D1 include selective regulation of the transcription machinery in resolution-phase mouse macrophages. FASEB J. 2014 Jul;28(7):3090-102. doi: 10.1096/fj.13-248393. Epub 2014 Apr 1.
- Background: PubMed 25616438Wang X, Hjorth E, Vedin I, Eriksdotter M, Freund-Levi Y, Wahlund LO, Cederholm T, Palmblad J, Schultzberg M. Effects of n-3 FA supplementation on the release of proresolving lipid mediators by blood mononuclear cells: the OmegAD study. J Lipid Res. 2015 Mar;56(3):674-681. doi: 10.1194/jlr.P055418. Epub 2015 Jan 23.
- Background: PubMed 22538616Chiang N, Fredman G, Backhed F, Oh SF, Vickery T, Schmidt BA, Serhan CN. Infection regulates pro-resolving mediators that lower antibiotic requirements. Nature. 2012 Apr 25;484(7395):524-8. doi: 10.1038/nature11042.
- Background: PubMed 23186989Mizwicki MT, Liu G, Fiala M, Magpantay L, Sayre J, Siani A, Mahanian M, Weitzman R, Hayden EY, Rosenthal MJ, Nemere I, Ringman J, Teplow DB. 1alpha,25-dihydroxyvitamin D3 and resolvin D1 retune the balance between amyloid-beta phagocytosis and inflammation in Alzheimer's disease patients. J Alzheimers Dis. 2013;34(1):155-70. doi: 10.3233/JAD-121735.
- Background: PubMed 21206090Oh SF, Pillai PS, Recchiuti A, Yang R, Serhan CN. Pro-resolving actions and stereoselective biosynthesis of 18S E-series resolvins in human leukocytes and murine inflammation. J Clin Invest. 2011 Feb;121(2):569-81. doi: 10.1172/JCI42545. Epub 2011 Jan 4.
- Background: PubMed 19103881Serhan CN, Yang R, Martinod K, Kasuga K, Pillai PS, Porter TF, Oh SF, Spite M. Maresins: novel macrophage mediators with potent antiinflammatory and proresolving actions. J Exp Med. 2009 Jan 16;206(1):15-23. doi: 10.1084/jem.20081880. Epub 2008 Dec 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Conte, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPM Emulsion, Dose-modality and SPM Softgel, Dose-Modality in people with Peripheral Arterial Disease and Claudication, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal Phase 1b Dose (time frame: Baseline, Day 33). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02719665, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.