An interventional study of Passive calf muscle stretching device in Peripheral Artery Disease and Claudication, Intermittent, sponsored by Penn State University. Recruiting at 1 site in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Penn State University · Not applicable, Interventional, and Treatment
Among 119 studies in Intermittent Claudication with a site in United States — 14 open to participants now, 17 under way, 2 of them phase 3. Intermittent Claudication · United States.
Among the 119 studies in Intermittent Claudication with a site in United States, this one is the 86th largest by planned enrollment of the 104 interventional ones that give a count, is one of 4 that started in 2024, is one of 43 with no phase, reaches primary completion later than 4 of the 16 other live ones, and was the 113th registered.
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
Browse Intermittent Claudication studies →14 of the 119 studies in Intermittent Claudication with a site in United States are open now. Recruiting first, the newest first:
Cook Research Incorporated · Sites in United States
Northwestern University · Sites in United States
Northwestern University · Sites in United States
Northwestern University · Sites in United States
University of Oklahoma · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 33 Intermittent Claudication studies recruiting now, 21 (64%) set no upper age limit and 0 (0%) stop at 75 or younger; 0 take children under 18; 1 take healthy volunteers.
This study: 40 Years to 85 Years · all sexes · no healthy volunteers.
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119 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 20 · Phase 2 24 · Phase 3 13 · Phase 4 9
First in 1994; this study’s year is marked. 4 started in 2024.
This study's planned enrollment of 24 is below the median of 74 across 242 interventional studies indexed under Intermittent Claudication.
Median enrollment 73 across the 104 interventional studies, 195 across the 15 observational. Of the 87 that completed or were terminated, 30 (34%) have results posted.
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49 of 119 have an industry lead sponsor. The 10 most frequent:
Penn State University is the lead sponsor of 270 studies on the registry; 53 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.
Penn State University has 2 studies filed under Intermittent Claudication — fewer than ten, so there is no comparison to draw.
7 of the studies in Intermittent Claudication with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05132439Phase 3VA Office of Research and DevelopmentMetfOrmin BenefIts Lower Extremities With Intermittent Claudication | 2027-02-28 |
| NCT06399809Northwestern UniversityFisetin to Reduce Senescence and Mobility Impairment in PAD | 2026-11 |
| NCT05145478Yale UniversityCRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions | 2026-12-31 |
| NCT02842424University of NebraskaRamipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis | 2027-06 |
| NCT06041880Penn State UniversityPassive Calf Stretching Therapy in Peripheral Artery Disease | 2027-06 |
Among the 119 studies in Intermittent Claudication with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to assess the effects of passive calf muscle stretching in patients diagnosed with peripheral artery disease (PAD). The main question it aims to answer are:
Participants will use inflatable ankle splints for 30 minutes a day, 5 days a week for 4-weeks on both days and 4-weeks of no stretching.
Patients with peripheral artery disease will passively stretch their calf muscles using a stretch device on both feet for 30 minutes a day for 4 weeks. Blood vessel health and size, length and function of the calf muscles and tendons and walking performance will be measured. Joint and foot movements as well as calf muscle oxygen levels will be measured during walking performance tests.
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
This study's planned enrollment of 24 is below the median of 74 across 242 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →Penn State University is the lead sponsor of 270 studies on the registry; 53 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.
Compared within Intermittent Claudication, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Peripheral Arterial Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle.
Device: Passive calf muscle stretching device
No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks.
Modified night splints will be used to passive stretch the calf muscle.
Also known as: Plantar fasciitis night splints
6-minute walk test distance
Submaximal exercise test used to assess aerobic capacity and endurance
Time frame: 6-12 minutes
Muscle to tendon ratio
The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound
Time frame: 45 minutes
Endothelial function
Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg.
Time frame: 30 minutes
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Jun 2027, 38 months after the start.
Of 73 non-industry interventional studies with no phase under Intermittent Claudication, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 77. This study's planned 38 months is below that.
Counting every sponsor, half of 84 studies reached it within 41 months; a quarter within 17 and three quarters within 77.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 2, 2026: primary completion Jul 2026 → Jun 2027 and completion Jul 2027 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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