| NCT ID | NCT06235463 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rowan University |
| Condition | Lymphedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2024-04-09 |
| Primary Completion | 2025-08-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2024-04-09 with a primary completion date of 2025-08-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06235463 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 100 Years, studying Lymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06235463 currently recruiting?
Yes, NCT06235463 is actively recruiting participants. Contact the research team at mclaugmh@rowan.edu for enrollment information.
Where is the NCT06235463 trial being conducted?
This trial is being conducted at Stratford, United States.
Who is sponsoring the NCT06235463 clinical trial?
NCT06235463 is sponsored by Rowan University. The trial plans to enroll 72 participants.