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New treatment option for Peripheral Arterial Disease
Official title Carnosine for Peripheral Arterial Disease Patients
ClinicalTrials.gov ID: NCT05371145
What this study is testing
What is Carnosine?
Carnosine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for peripheral arterial disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Oral supplementation of L-carnosine will increase muscle carnosine, stabilize HIF1-alpha promote angiogenesis, and thus improve the functioning of lower extremities in PAD patients.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80, men only
You may be able to join if
- Male people more than \>50 to \<80 years of age.
- White or African American race.
- English Speaking.
- ABI 0.4-\< 0.60
- Willing to comply with protocol requirements.
You likely can't join if
- people with HIV, hepatitis, significant liver disease, active infection, anemia, organ transplant, renal disease requiring dialysis, lung disease...
- Diagnosis of carnosinemia.
- Known allergy to L-carnosine or meat.
- Presence of a pacemaker.
- Obesity from a known genetic defect.
- Dementia.
See the full eligibility criteria
- Male people more than \>50 to \<80 years of age.
- White or African American race.
- English Speaking.
- ABI 0.4-\< 0.60
- Willing to comply with protocol requirements.
- Able to provide informed consent. -
- people with HIV, hepatitis, significant liver disease, active infection, anemia, organ transplant, renal disease requiring dialysis, lung disease requiring oxygen, significant congenital heart disease, cancer of any...
- Diagnosis of carnosinemia.
- Known allergy to L-carnosine or meat.
- Presence of a pacemaker.
- Obesity from a known genetic defect.
- Dementia.
- Critical limb ischemia with below or above knee amputations.
- Foot ulcers.
- Major amputations.
- Participating in other clinical trials.
- End stage renal disease.
- Presence of significant injury within 30 days before enrollment.
- Prisoners.
- Any metallic implants.
- Poorly controlled diabetes (HbA1C \>9%) -
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louisville, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.