Pedal Pump and Leg Lymphedema
Rowan University · NCT06235463
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 55–100 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 72
- US sites recruiting
- 1
- Study start
- April 9, 2024
- Record last updated
- November 18, 2024
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
Chronic lymphedema in the lower extremities is a common problem found in older adults that can result in cellulitis, poor wound healing, venous stasis ulcers, and other comorbidities. Compressive therapies are the present gold standard for the manual treatment of lymphedema in the lower extremities. However, the benefits of these compressive therapies are modest, and they are not well tolerated by older adults. An alternative manual treatment is the osteopathic pedal pump, an osteopathic manipulative treatment, that uses a rhythmical pumping motion instead of compressive force to move interstitial fluid from the lower extremities back to the circulatory system. However, the evidence that the osteopathic pedal pump can reduce volume in the lower extremities remains anecdotal. The aim of this study is to determine if the osteopathic pedal pump can reduce volume in the lower extremities among older adults with chronic lymphedema. Leg volume will be measured using water displacement. Older adults with chronic lymphedema of the lower extremities will be randomly assigned to one of two groups: a treatment group that will receive one session of the osteopathic pedal pump and a control group that will receive one session of a light touch treatment.
Being studied: Osteopathic Pedal Pump; Light Touch Treatment
Conditions: Lymphedema
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Age 55 years old or older
- Have lower leg lymphedema
Exclusion Criteria
- Any type of acute medical issue or exacerbation
- A chronic medical condition (e.g., asthma, chronic obstructive pulmonary disease, congestive heart failure)
- An active tissue infection or an open wound in the lower limb
- An active bone fracture
- Acute deep venous thrombosis not fully anticoagulated
- Dementia
Recruiting US locations
Rowan University School of Osteopathic Medicine
Stratford, NJ 08084
Site contact: Matt McLaughlin · (856) 566-6330 · mclaugmh@rowan.edu
Study contacts (from the official record)
- Matt McLaughlin · (856) 566-6330 · mclaugmh@rowan.edu
Similar studies in New Jersey
All healthy volunteers studies in New Jersey →- RecruitingHealthy volunteersPhase 1
Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234
Arcutis Biotherapeutics, Inc.
- Location
- Fair Lawn, NJ + 6 other US sites
- Eligibility basics
- Ages 18–65
- RecruitingHealthy volunteersPhase 1
A Clinical Trial of MK-1406 in Healthy Participants (MK-1406-008)
Merck Sharp & Dohme LLC
- Location
- Marlton, NJ + 5 other US sites
- Eligibility basics
- Ages 18–64
- RecruitingHealthy volunteersPhase 1/Phase 2
Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
Sanofi
- Location
- Jersey City, NJ + 49 other US sites
- Eligibility basics
- Ages 60+
- RecruitingHealthy volunteersPhase 1
Study of Single Doses of HBS-104 in Acutely Sleep-deprived Healthy Participants
Harmony Biosciences Management, Inc.
- Location
- Eatontown, NJ
- Eligibility basics
- Ages 18–55