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Pedal Pump / Congestive Heart Failure(chf) / Chronic Venous Insufficiency (CVI) · Interventional Study
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a recruiting feasibility trial of a novel Pedal Pump device for hospitalized patients with lower extremity edema, designed to assess safety, tolerability, and feasibility over a 10-minute treatment session. No results are reported in this registry record; the study is in early development and the investigators explicitly state the need for product advancements and further testing with larger populations.
Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Lower Extremity Edema, Congestive Heart Failure(CHF), Chronic Venous Insufficiency (CVI), Kidney Disease; age from 18 Years. Intervention: Treatment Group. Compared with: Sham (Control) Group — Sham Comparator. n = 60. 1 site: United States.
Primary outcomes are treatment-related adverse events (CTCAE v4.0 grades 3–5), treatment tolerability, and change in lower extremity edema, all measured at 10 minutes Estimated enrollment: 60 participants Intervention: Pedal Pump device versus sham control
Primary outcomes are treatment-related adverse events (CTCAE v4.0 grades 3–5), treatment tolerability, and change in lower extremity edema, all measured at 10 minutes
Until results are posted, this record documents only the planned approach to a feasibility question. Clinicians should not infer efficacy or safety from the registration alone; results from this trial and subsequent larger studies will be needed to inform clinical adoption.
This is a recruiting trial registration with no results reported; it is a feasibility study of a novel device in early development, designed to assess safety and tolerability rather than efficacy.
As stated by the source record.
Quoted from the source exactly as published.
Until results are posted, this record documents only the planned approach to a feasibility question. Clinicians should not infer efficacy or safety from the registration alone; results from this trial and subsequent larger studies will be needed to inform clinical adoption.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT07760363). This is a study registration, not published results. Lead sponsor: David McVay. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Lower Extremity Edema, Congestive Heart Failure(CHF), Chronic Venous Insufficiency (CVI), Kidney Disease. Interventions: DEVICE: Pedal Pump; DEVICE: Pedal Pump Sham. Primary outcome measures: No Treatment-Related Adverse Events Scoring 3, 4, or 5 on the CTCAE v4.0 scale , 10 minutes; Treatment Tolerability , 10 minutes; Change in Lower Extremity Edema , 10 minutes. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.