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Pedal Pump / Lower Extremity Edema Chronic / Pedal Pump Sham · Interventional Study
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered feasibility trial of a mechanical device (Pedal Pump) for lower extremity edema in hospitalized patients. No results are reported in this registry record; the study is currently recruiting. The primary aim is to establish tolerability in the treatment group, with secondary measurement of edema reduction.
Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Lower Extremity Edema, Lower Extremity Edema Chronic, CHF - Congestive Heart Failure, CHF Exacerbation, Chronic Venous Insufficiency, CVI; age from 18 Years. Intervention: Treatment Group. Compared with: Sham (Control) Group — Sham Comparator. n = 30. 1 site: United States.
This is a registered feasibility trial of a mechanical device (Pedal Pump) for lower extremity edema in hospitalized patients. No results are reported in this registry record; the study is currently recruiting. The primary aim is to establish tolerability in the treatment group, with secondary measurement of edema reduction.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a clinical trial registry record for a planned feasibility study with no results posted; it describes early-stage device development with an estimated sample of 30 participants and tolerability as the primary outcome.
As stated by the source record.
Quoted from the source exactly as published.
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.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07809516). This is a study registration, not published results. Lead sponsor: Hillcrest. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Lower Extremity Edema, Lower Extremity Edema Chronic, CHF - Congestive Heart Failure, CHF Exacerbation, Chronic Venous Insufficiency, CVI. Interventions: DEVICE: Pedal Pump; DEVICE: Pedal Pump Sham. Primary outcome measures: Treatment Tolerability in at least 19 of the 20 patients in the Pedal Pump treatment group , 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, almost the same as Pedal Pump Clinical Trial on Edema V1 that is underway; however, this study focuses primarily on the objective data gathered by trained Occupational Therapists who regularly measure lower extremities. Key Question for this second 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.