Intermittent ClaudicationNCT03511157
Ischemic Preconditioning Claudication Study
A study testing Ischemic Preconditioning in people with Intermittent Claudication and Ischemia Vascular, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking distance in patients with intermittent claudication. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intermittent Claudication, Ischemia Vascular, Peripheral Arterial Disease
- What is being tested?
- Ischemic Preconditioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2018to 13 Dec 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between ages of 18-80
- able to give informed consent
- presence of vascular disease with intermittent claudication
Who cannot join
- age < 18 or >80
- unable to give informed consent
- presence of vascular disease with leg pain at rest, ischemic ulceration, or gangrene
- pregnancy
- unable to walk on a treadmill
- unable to perform or tolerate ischemic preconditioning
Show all 12Show fewer
- unable to follow commands
- exercise capacity limited by symptoms of angina, congestive heart failure, chronic obstructive pulmonary disease, or arthritis to be determined by PI
- patients who have undergone vascular surgery or endovascular surgery in the previous year on the affected leg
- history of major lower extremity amputation
- history of major psychiatric disorder
- history of uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Walking Capacity of Patients With Claudication in Lower Extremities Following Ischemic Preconditioning
This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking distance in patients with intermittent claudication.
Read the detailed description
This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking distance in patients with intermittent claudication. Peripheral arterial disease (PAD) is a circulatory condition in which large supply blood vessels narrow, reducing oxygen and nutrient distribution to peripheral tissues. IPC protects against tissue damage caused by ischemia and can improve functional capacity in patients recovering from stroke; however, the benefit of ischemic preconditioning in patients with peripheral arterial disease remains unclear.
The investigators predict that ischemic preconditioning (IPC) will delay claudication onset time (COT), increase peak walking time (PWT) and improve muscle strength in patients with intermittent claudication.
The investigators will determine whether IPC improves claudication onset time (COT) and peak walking time (PWT) in patients with intermittent claudication. A motorized treadmill will be employed to assess COT and PWT.
The investigators will determine whether IPC can improve muscle strength and time to pain onset in the affected leg of patients with intermittent claudication. These metrics will be assessed quantitatively using a Biodex™ dynamometer.
- Conditions
- Intermittent Claudication, Ischemia Vascular, Peripheral Arterial Disease, Peripheral Vascular Disease
- Being tested
- Ischemic Preconditioning, Control Group
- Keywords
- ischemic preconditioning
- Medical subject headings
- Intermittent Claudication, Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic PreconditioningOther
See Ischemic Preconditioning Experimental group description
Control GroupOther
See Control group description
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Preconditioning | Experimental | A standard blood pressure cuff will be placed on the right or left thigh, depending on the affected side, to occlude blood flow. The cuff will be inflated to 225 mmHg to prevent blood flow. Each session will consist of 4 cycles of 5 minute IPC applications, followed by 5 minutes of reperfusion for a total of 35 minutes. Receives: Other: Ischemic Preconditioning |
| Control | Sham comparator | The sham intervention protocol will be identical to the IPC protocol except blood flow to the affected leg is unchanged as cuff pressure will be raised to between the venous and diastolic pressures Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak walking time
Subjects will be placed on a motorized treadmill and peak walking time will be recorded in seconds.
Measured: 2 weeks
Secondary outcomes (2)
Muscle Fatigue
Subjects will perform muscle contractions for muscle groups of interest (knee extensors/flexors and dorsiflexors/plantarflexors). Contractions will be measured in newton-meters. The duration will be determined by the time subjects first feel pain and when the pain becomes too great to continue. The investigators will provide subjects with visual feedback on the monitor throughout the testing.
Measured: 2 weeks
Claudication onset time
Subjects will be placed on a motorized treadmill and claudication onset time will be recorded in seconds.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start14 Jun 2018
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Durand, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511157
- Sponsor's protocol ID
- PRO00031772
- Status last verified
- Dec 2022
- First submitted
- 9 Apr 2018
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking Capacity of Patients With Claudication in Lower Extremities Following Ischemic Preconditioning
- ClinicalTrials.gov ID
- NCT03511157
- Acronym / sponsor ID
- PRO00031772
- Conditions
- Intermittent Claudication, Ischemia Vascular, Peripheral Arterial Disease, Peripheral Vascular Disease
- Keywords
- ischemic preconditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 27 Apr 2018 (actual)
- 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.
This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking distance in patients with intermittent claudication.
Detailed description
This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking distance in patients with intermittent claudication. Peripheral arterial disease (PAD) is a circulatory condition in which large supply blood vessels narrow, reducing oxygen and nutrient distribution to peripheral tissues. IPC protects against tissue damage caused by ischemia and can improve functional capacity in patients recovering from stroke; however, the benefit of ischemic preconditioning in patients with peripheral arterial disease remains unclear.
The investigators predict that ischemic preconditioning (IPC) will delay claudication onset time (COT), increase peak walking time (PWT) and improve muscle strength in patients with intermittent claudication.
The investigators will determine whether IPC improves claudication onset time (COT) and peak walking time (PWT) in patients with intermittent claudication. A motorized treadmill will be employed to assess COT and PWT.
The investigators will determine whether IPC can improve muscle strength and time to pain onset in the affected leg of patients with intermittent claudication. These metrics will be assessed quantitatively using a Biodex™ dynamometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Preconditioning | Experimental | Other: Ischemic PreconditioningA standard blood pressure cuff will be placed on the right or left thigh, depending on the affected side, to occlude blood flow. The cuff will be inflated to 225 mmHg to prevent blood flow. Each session will consist of 4 cycles of 5 minute IPC applications, followed by 5 minutes of reperfusion for a total of 35 minutes. |
| Control | Sham comparator | Other: Control GroupThe sham intervention protocol will be identical to the IPC protocol except blood flow to the affected leg is unchanged as cuff pressure will be raised to between the venous and diastolic pressures |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between ages of 18-80
- able to give informed consent
- presence of vascular disease with intermittent claudication
Key exclusion criteria (12 listed)
- age < 18 or >80
- unable to give informed consent
- presence of vascular disease with leg pain at rest, ischemic ulceration, or gangrene
- pregnancy
- unable to walk on a treadmill
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 |
|---|---|---|
| Ischemic PreconditioningSee Ischemic Preconditioning Experimental group description | Other | Ischemic Preconditioning |
| Control GroupSee Control group description | Other | Control |
Primary outcome
Peak walking time
Time frame: 2 weeks
Subjects will be placed on a motorized treadmill and peak walking time will be recorded in seconds.
2 secondary outcomes
Muscle Fatigue
Time frame: 2 weeks
Claudication onset time
Time frame: 2 weeks
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 14 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Intermittent Claudication
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Recruiting
Passive Calf Stretching Therapy in Peripheral Artery Disease
Peripheral Artery Disease, Claudication, Intermittent
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic Preconditioning in people with Intermittent Claudication and Ischemia Vascular, run by Medical College of Wisconsin 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 3 inclusion and 12 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 14 Dec 2022. 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?
Peak walking time (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2022.