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Creatine monohydrate for Peripheral Arterial Disease

Phase 2
Waitlist Available
Led By Judy Muller-Delp, Ph.D.
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ankle-brachial index (ABI) of 0.90 or less in either leg or clinical diagnosis by a medical doctor (PAD group only)
Stable condition for at least 3 months (PAD group only)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial is investigating whether a research device that induces muscle stretching, and creatine loading, impacts submaximal exercise performance in aged and PAD patients.

Eligible Conditions
  • Peripheral Arterial Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Walking tolerance
Secondary outcome measures
Magnetic Resonance Imaging (MRI)
Near infrared spectroscopy (NIRS)

Side effects data

From 2015 Phase 4 trial • 14 Patients • NCT01514630
71%
Cold and flu symptoms
29%
Diarrhea
21%
Stomach Discomfort
14%
Muscle Cramps
7%
Lightheaded
7%
Headache
7%
Nausea
7%
Indigestion
7%
Polydipsia
7%
Swelling in Hands
7%
Numbness and Tingling in hands
100%
80%
60%
40%
20%
0%
Study treatment Arm
Creatine Monohydrate

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Creatine monohydrateExperimental Treatment1 Intervention
Creatine Monohydrate will be given at a 5 day loading period (10g/day) followed by a maintenance phase (5 g/day). The objectives of the current trial are to investigate if creatine supplementation plus muscle stretching improves 6-minute walking distance and muscle oxygenation in patients with peripheral artery disease.
Group II: CellulosePlacebo Group1 Intervention
These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Creatine monohydrate
2005
Completed Phase 4
~620

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor
197 Previous Clinical Trials
30,627 Total Patients Enrolled
2 Trials studying Peripheral Arterial Disease
53 Patients Enrolled for Peripheral Arterial Disease
Judy Muller-Delp, Ph.D.Principal InvestigatorProfessor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any deleterious effects from taking Creatine monohydrate?

"Based on its Phase 2 status, Creatine monohydrate's safety has been rated as a 2 - there is evidence to suggest it is safe but none that confirms efficacy."

Answered by AI

What is the aggregate number of participants in this clinical trial?

"Confirmatory evidence from clinicaltrials.gov signals that the investigation is actively enlisting volunteers, with recruitment beginning on May 12th 2020 and last updated March 16th 2022. This project requires 40 people between 1 location to take part in its experimentations."

Answered by AI

What criteria must individuals meet to qualify for participation in this clinical trial?

"To be considered for this trial, individuals must have peripheral arterial disease and an age between 40-95. Currently, 40 participants are being recruited for the study."

Answered by AI

Is enrollment available during this period of the clinical trial?

"Per clinicaltrials.gov, this research is still actively seeking participants after being initially posted on May 12th 2020 and last modified on March 16th 2022."

Answered by AI

Are individuals aged 75 and beyond eligible to participate in this trial?

"Individuals who meet the criteria for this clinical trial should be between 40 and 95 years old. Additionally, 11 research projects are available to people younger than 18, while 210 trials cater to seniors over 65."

Answered by AI
~3 spots leftby Mar 2025