TerminatedPhase 1/2

Wireless TENS for Peripheral Edema (Lower Limb Swelling)

Stopped: Terminated early due to lack of time.

United States3 participantsStarted 2021-06-28

Plain-language summary

This study is single center, subject will receive a wireless TENS device. All subjects will be allowed to keep the commercially-available device for use after the study. The primary goal is to test the feasibility of the study design and secondary is to test the preliminary efficacy of the TENS.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Have had lower extremity edema for at least 3 months.
. Currently have edema of at least 2+ (i.e., 3-4mm depression rebounds within a few seconds, but not immediately) on the pitting scale. 21 Pitting will have been assessed by a Clinician, the clinician Co-I within 6 weeks of the screening visit or at the screening visit by the research staff.
. Willing to not start or change the dosages of any medications that could affect edema for 2 weeks prior to enrollment, and throughout the duration of the study.
. Not currently using diuretics to control their edema.
. Not currently using and willing to not start using occupational therapy, physical therapy, or lymphatic massage (at home or by PT) 2 weeks prior to and throughout the duration of the study.
. Not currently using compression stockings or Velcro or bandage wraps at least 2 weeks prior to enrollment in the study or based on shared decision making of the potential subjects' clinician or the clinician co-investigator are receiving sufficiently little benefit from these therapies to warrant stopping their use for the duration of the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change in Edema Symptom Diary Score

Timeframe: From baseline visit (Day 0) to final endpoint visit (Day 21)

Trial details

NCT IDNCT04680533

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-22

Results submitted2025-07-10

View on ClinicalTrials.gov More Peripheral Edema trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Have had lower extremity edema for at least 3 months.
. Currently have edema of at least 2+ (i.e., 3-4mm depression rebounds within a few seconds, but not immediately) on the pitting scale. 21 Pitting will have been assessed by a Clinician, the clinician Co-I within 6 weeks of the screening visit or at the screening visit by the research staff.
. Willing to not start or change the dosages of any medications that could affect edema for 2 weeks prior to enrollment, and throughout the duration of the study.
. Not currently using diuretics to control their edema.
. Not currently using and willing to not start using occupational therapy, physical therapy, or lymphatic massage (at home or by PT) 2 weeks prior to and throughout the duration of the study.
. Not currently using compression stockings or Velcro or bandage wraps at least 2 weeks prior to enrollment in the study or based on shared decision making of the potential subjects' clinician or the clinician co-investigator are receiving sufficiently little benefit from these therapies to warrant stopping their use for the duration of the study.

Wireless TENS for Peripheral Edema (Lower Limb Swelling)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Wireless TENS for Peripheral Edema (Lower Limb Swelling)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria