Peripheral Artery DiseaseNCT04222751
Static Muscular Stretching for Treatment of PAD
A study testing Ankle Splint in people with Peripheral Artery Disease, run by Florida State University at 1 site in United States.
Trial summary
Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. The investigator's pilot study in PAD patients has shown that endothelial function and walking distance improve with regular static muscle stretching. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Ankle Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2020to 1 Jun 2025
- 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40+
- A resting ankle-brachial index (ABI) of 0.90 or less in either leg
- Stable disease (PAD) for a minimum of 3-months
Who cannot join
- Habitual exercise (30 minutes of continuous activity for 3 or more days per week)
- Cardiovascular rehabilitation program during the past 3 months
- Below or above-knee amputation, critical limb ischemia (ulceration or gangrene)
- Leg pain at rest
- Cardiorespiratory disease
- Diabetes
Show all 15Show fewer
- Major surgery or lower extremity revascularization during the previous 3 months
- Major medical illness treatment during the prior 12 months
- Central neurological disease
- Limited ankle or knee joint range of motion
- Requirement of oxygen with activity or exercise
- More than a class II New York Heart Association level of heart failure
- Wheelchair confinement, or inability to walk
- Cognitive disorder
- Vasculitis problem including Takayasu's arteritis, Buerger's disease, collagen disease or Raynaud's disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Static Muscular Stretching for Treatment of Peripheral Artery Disease
Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. The investigator's pilot study in PAD patients has shown that endothelial function and walking distance improve with regular static muscle stretching. Therefore, the purpose of this study is to determine whether prescriptive muscle stretching improves muscle oxygenation and walking ability in PAD patients. This is a single-blinded study in 40 patients with stable symptomatic PAD. Patients assigned to the stretch group will use ankle splints (both legs) to perform static muscle stretching for 4 weeks (ankle dorsiflexion applied 30 min/d, 5 days/wk). Patients assigned to the control group will also wear the ankle splints daily but without invoking any dorsiflexion, i.e., without stretching. Measurements will consist of ankle-brachial index (ABI) at rest and post-exercise, skeletal muscle oxygenation (evaluated with near-infrared spectroscopy (NIRS)), and 6 minute walk test (6MWT), performed at baseline and after 4 weeks of stretching (or control splint placement). In addition, NIRS will be used to evaluate muscle oxygenation while patients are wearing the splint device in order to quantitatively prescribe the angle of dorsiflexion that provides optimum stretch and deoxygenation of the calf muscles without causing pain. Primary outcomes include increased muscle oxygenation during exercise and walking distance after 4 weeks of static muscle stretching. Results from this study will be used to support funding applications for a larger efficacy trial.
- Conditions
- Peripheral Artery Disease
- Being tested
- Ankle Splint
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle SplintDevice
Ankle splint will be slightly modified from the commercial form to include a pneumatic air cell secured under the forefoot below the splint's padded lining. This replaces the foam wedge provided by the manufacturer, allowing a gradual adjustment of the forefoot/toe region.
| Study group | Role | What they receive |
|---|---|---|
| Stretch Group | Experimental | Subjects assigned to this group will be instructed on how to wear the device to produce the appropriate amount of dorsiflexion (stretch). Splint devices will be worn at the assigned angle 5 days/week, 30 minutes/day, for 4 weeks. ABI, muscle oxygenation, and walking distance will be assessed pre/post stretching. Other health surveys will be administered. Receives: Device: Ankle Splint |
| No Stretch Group | Placebo comparator | Subjects assigned to this group will wear the splints but instructed to wear the device in a position that produces no stretch. Splint devices will be worn at the assigned angle 5 days/week, 30 minutes/day, for 4 weeks. ABI, muscle oxygenation, and walking distance will be assessed pre/post stretching. Other health surveys will be administered. Receives: Device: Ankle Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Oxygenation
Noninvasive assessment via NIRS monitor
Measured: 4 weeks
Change in Continuous Walking Distance
Assessed by 6-minute walking test
Measured: 4 weeks
Change in Total Walking Distance
Assessed by 6-minute walking test
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start29 Jul 2020
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, Emily Pritchard, Florida State University
- Investigators
- Judy Delp, PhD, Principal investigator, Florida State UniversityEmily Pritchard, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222751
- Sponsor's protocol ID
- 19-005234 Mayo
- Status last verified
- Aug 2025
- First submitted
- 7 Jan 2020
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Static Muscular Stretching for Treatment of Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT04222751
- Acronym / sponsor ID
- 19-005234 Mayo
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 10 Jan 2020 (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.
Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. The investigator's pilot study in PAD patients has shown that endothelial function and walking distance improve with regular static muscle stretching. Therefore, the purpose of this study is to determine whether prescriptive muscle stretching improves muscle oxygenation and walking ability in PAD patients. This is a single-blinded study in 40 patients with stable symptomatic PAD. Patients assigned to the stretch group will use ankle splints (both legs) to perform static muscle stretching for 4 weeks (ankle dorsiflexion applied 30 min/d, 5 days/wk). Patients assigned to the control group will also wear the ankle splints daily but without invoking any dorsiflexion, i.e., without stretching. Measurements will consist of ankle-brachial index (ABI) at rest and post-exercise, skeletal muscle oxygenation (evaluated with near-infrared spectroscopy (NIRS)), and 6 minute walk test (6MWT), performed at baseline and after 4 weeks of stretching (or control splint placement). In addition, NIRS will be used to evaluate muscle oxygenation while patients are wearing the splint device in order to quantitatively prescribe the angle of dorsiflexion that provides optimum stretch and deoxygenation of the calf muscles without causing pain. Primary outcomes include increased muscle oxygenation during exercise and walking distance after 4 weeks of static muscle stretching. Results from this study will be used to support funding applications for a larger efficacy trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretch Group | Experimental | Device: Ankle SplintSubjects assigned to this group will be instructed on how to wear the device to produce the appropriate amount of dorsiflexion (stretch). Splint devices will be worn at the assigned angle 5 days/week, 30 minutes/day, for 4 weeks. ABI, muscle oxygenation, and walking distance will be assessed pre/post stretching. Other health surveys will be administered. |
| No Stretch Group | Placebo comparator | Device: Ankle SplintSubjects assigned to this group will wear the splints but instructed to wear the device in a position that produces no stretch. Splint devices will be worn at the assigned angle 5 days/week, 30 minutes/day, for 4 weeks. ABI, muscle oxygenation, and walking distance will be assessed pre/post stretching. Other health surveys will be administered. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40+
- A resting ankle-brachial index (ABI) of 0.90 or less in either leg
- Stable disease (PAD) for a minimum of 3-months
Key exclusion criteria (15 listed)
- Habitual exercise (30 minutes of continuous activity for 3 or more days per week)
- Cardiovascular rehabilitation program during the past 3 months
- Below or above-knee amputation, critical limb ischemia (ulceration or gangrene)
- Leg pain at rest
- Cardiorespiratory disease
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 |
|---|---|---|
| Ankle SplintAnkle splint will be slightly modified from the commercial form to include a pneumatic air cell secured under the forefoot below the splint's padded lining. This replaces the foam wedge provided by the manufacturer, allowing a gradual adjustment of the forefoot/toe region. | Device | No Stretch Group, Stretch Group |
Primary outcome
Change in Muscle Oxygenation
Time frame: 4 weeks
Noninvasive assessment via NIRS monitor
Change in Continuous Walking Distance
Time frame: 4 weeks
Assessed by 6-minute walking test
Change in Total Walking Distance
Time frame: 4 weeks
Assessed by 6-minute walking test
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 15 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Judy Delp, PhD principal investigator
Florida State University
Emily Pritchard, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle Splint in people with Peripheral Artery Disease, run by Florida State University 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 15 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 15 Aug 2025. 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?
Change in Muscle Oxygenation (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 15 Aug 2025.