An interventional study of Pedal Pump and Pedal Pump Sham in Lower Extremity Edema, Congestive Heart Failure(CHF) and Chronic Venous Insufficiency (CVI), sponsored by David McVay. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by David McVay · Not applicable, Interventional, and Treatment
Among 2,156 studies in Heart Failure with a site in United States — 348 open to participants now, 437 under way, 27 of them phase 3. Heart Failure · United States.
Among the 2,156 studies in Heart Failure with a site in United States, this one is the 815th largest by planned enrollment of the 1,600 interventional ones, is one of 95 that started in 2026, is one of 886 with no phase, reaches primary completion later than 106 of the 436 other live ones, and was the 2,137th registered.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 60 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →348 of the 2,156 studies in Heart Failure with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 968 Heart Failure studies recruiting now, 691 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 64 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →2,156 studies; the count open now beside each. This study's row is marked.
First in 1983; this study’s year is marked. 95 started in 2026.
Median enrollment 65 across the 1,600 interventional studies, 150 across the 551 observational. Of the 1,509 that completed or were terminated, 629 (42%) have results posted.
745 of 2,156 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with David McVay as lead sponsor.
David McVay has 1 study filed under Heart Failure — fewer than ten, so there is no comparison to draw.
139 of the studies in Heart Failure with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02901184Phase 3Uppsala UniversitySpironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction | 2026-12 |
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT06736574Phase 3CytokineticsStudy With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction | 2027-09 |
| NCT06024746Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) | 2027-11 |
| NCT06008197Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients | 2027-11 |
Among the 2,156 studies in Heart Failure with a site in United States, from their registry updates:
Previous research on the osteopathic manual technique entitled "Pedal Pump" has shown health benefits, specifically increasing lymphatic flow, decreasing lower extremity edema, and decreasing serum lactic acid after maximal exercise. However, due to the limitation of human practitioners, research has been limited.
The Pedal Pump is now a device which facilitates consistency in treatment and allows for increased sample size in research. This clinical trial studies the effects of 10 minutes of Pedal Pump treatment for hospitalized patients with lower extremity edema.
Key Question for this first study: Is the Pedal Pump a feasible treatment for hospitalized patients? Secondary question: Does the Pedal Pump decrease lower extremity edema?
This is a novel idea in its early stage of development, so Investigators anticipate product advancements, further testing with larger population sizes, and future publications.
The Pedal Pump is a device which engages the feet of patients while they are in bed. The device is placed between the foot board and the patient's feet. It provides gentle, on-and-off pressure to the feet, which, in turn, mobilizes the whole body in a rhythmic, calming manner.
The proposed hypotheses of the Pedal Pump are primarily based on the health benefits provided by normal walking. They include, but are not limited to…
Physiological Benefits
Proposed Patient-Centered Benefits
For this first, feasibility study the Investigators will be investigating if the Pedal Pump is tolerated by hospitalized patients, and if so, does it decrease lower extremity edema.
Treatment:
Objective Measures: Assessments of the feet and legs will be taken pre-treatment (Minute 0), post-treatment (Minute 10-15), and follow-up (45-60 minutes after post-treatment):
Subjective Measures: The below Symptoms will be rated by the patient pre-treatment, post-treatment, and at follow-up. Ratings range from 0 (none), 1 (mild), 2 (moderate), 3 (severe).
Thresholds for clinically meaningful change:
Treatment vs Sham
Routine care
Data Storage and Analysis:
Statistical methods:
Handling of missing data:
Device Description and Engineering Safety
Device Specifications
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Treatment group will experience the Pedal Pump intervention by... 1. Being assisted to sit up in their beds at a 45-60 degree Fowler's position. Their thighs, calves, and ankles being marked with a surgical marker at the locations and measured. 2. The heel protector pillows being attached to their feet and the Pedal Pump being placed at the foot of the bed. 3. Provided the treatment is tolerated by the patient, the Pedal Pump treatment being applied to both feet for 10 minutes continuously mobilizing their whole body in sufficient manner to see the nose move. 4. The Operator turning off the device and removing it from the bed.
Device: Pedal Pump
The Sham Group will have the same experience as Treatment Group with the exact same device generating identical operational sounds and visible movement, but the patient's body will not be close enough to the device to produce sufficient displacement to transmit mechanical forces beyond the feet. The Pedal Pump will only contact the heel protector pillows enough to make the toes move but will not contact them enough to mobilize the legs or the entire body.
Device: Pedal Pump Sham
The Pedal Pump device pumps both feet for 10 minutes continuously-- mobilizing their whole body in sufficient manner to see the nose move.
Also known as: Foot Pump, Foot Mobilizer, Feet Mover
The Sham Intervention is the same as Pedal Pump Intervention with the exact same Pedal Pump device generating identical operational sounds and visible movement; however, the patient's body will not be close enough to the device to produce sufficient displacement to transmit mechanical forces beyond the feet. The Pedal Pump will only contact the heel protector pillows enough to make the toes move but will not contact them enough to mobilize the legs or the entire body.
No Treatment-Related Adverse Events Scoring 3, 4, or 5 on the CTCAE v4.0 scale
Treatment-related adverse events will be assessed by CTCAE v4.0 on a 1-5 scale: * Grade 1 (Mild): Asymptomatic or mild symptoms. * Grade 2 (Moderate): Minimal, local, or noninvasive intervention indicated. * Grade 3 (Severe): Severe but not immediately life-threatening; hospitalization indicated. * Grade 4 (Life-threatening): Urgent intervention indicated. * Grade 5 (Death): Death related to the AE. Adverse Events monitors will be such as, but not limited to: * New pain * Worsened pain * Dizziness * Blood pressure instability * Skin irritation * Muscle cramping * Abdominal cramping * Anxiety * Nausea * Syncope * Chest pain of cardiac origin * Sustained arrhythmia * Stroke symptoms * Hypoxia * Hypotension Treatment will stop immediately if a Grade 3, 4, or 5 adverse event occurs. The Investigators will keep record of the number of patients having adverse events and their severities.
Time frame: 10 minutes
Treatment Tolerability
≥95% treatment tolerability (\<5% "aborted" treatments)
Time frame: 10 minutes
Change in Lower Extremity Edema
≥1 cm change in average lower extremity circumferences
Time frame: 10 minutes
No increase in pain or stress in ≥80% of the treatment group
No increase in pain or stress in ≥80% of the treatment group per patient-reported symptoms using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe)
Time frame: 10 minutes
<20% of Treatment Group having Treatment-Related Adverse Events scoring 2 per CTCAE v4.0
Treatment-related adverse events will be assessed by CTCAE v4.0 on a 1-5 scale: * Grade 1 (Mild): Asymptomatic or mild symptoms. * Grade 2 (Moderate): Minimal, local, or noninvasive intervention indicated. * Grade 3 (Severe): Severe but not immediately life-threatening; hospitalization indicated. * Grade 4 (Life-threatening): Urgent intervention indicated. * Grade 5 (Death): Death related to the AE. Adverse Events monitors will be such as, but not limited to: * New pain * Worsened pain * Dizziness * Blood pressure instability * Skin irritation * Muscle cramping * Abdominal cramping * Anxiety * Nausea * Syncope * Chest pain of cardiac origin * Sustained arrhythmia * Stroke symptoms * Hypoxia * Hypotension
Time frame: 10 minutes
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Age Sex Weight BMI Receiving IV diuretics Receiving oral diuretics Active CHF Active chronic venous insufficiency Acute kidney disease Chronic kidney disease End Stage Renal Disease (ESRD) Active Hypertension History of Myocardial infarction History of Stroke Active Diabetes Smoking 5+ years history Active pain
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anticipated Start-Date: October 31, 2026 Anticipated End-Date: January 1, 2040
Access criteria: After publication, de-identified IPD will be shared with qualified independent researchers under strict data-use agreements to verify findings and conduct new scientific work. We will allow said researchers to have "view only" access to the electronic folder containing the de-identified IPD. Researchers can email their requests to davidwilliammcvay@gmail.com.
Started Aug 2026 (actual). Primary completion is estimated for Sep 2026, 1 month after the start.
Of 236 industry-sponsored interventional studies with no phase under Heart Failure, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 62. This study's planned 1 month is below that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.