Peripheral EdemaPhase 1/2NCT04680533
Wireless TENS for Peripheral Edema (Lower Limb Swelling)
A Phase 1/2 study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Peripheral Edema, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Edema
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2021to 22 Feb 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Have access to a smart phone or device with an Apple or Android operating system with iOS 10 or later, or Android 6 or later. iOS and Android devices must have Bluetooth Low Energy (LE, also called Bluetooth Smart) compatibility. The smart phone or device must have the ability to access the TENS device's Quell App, Zoom App or software and, the ability to connect to the cellular data or Wi-Fi on a daily basis during the trial.
- Have an active and accessible email.
- Be willing and able to regularly check the email provided throughout the study.
- Be able to read English (i.e., is literate, can speak English, and is not blind) because patient-reported outcomes and consent form are only available in English.
- Be at least 18 years of age.
- Be able to provide informed consent.
Who cannot join
- Be currently using a TENS device for any reason.
- Have an acute and symptomatic lower extremity DVT (i.e., the diagnosis of DVT is less than 3 months prior to study enrollment).
- Have started anticoagulants within the past 3 months.
- Have lower extremity wounds or ulcers.
- Have a cardiac pace maker or defibrillator.
- Have epilepsy.
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- Have a leg that is too small or too large for the TENS device to fit securely.
- Have cellulitis or fibrosis.
- Have any skin condition at the site where the electrode pads adhere such that the PI/Co-I think the device will not be safe for the subject.
- Have congestive heart failure.
- Have chronic kidney disease of stage 3 or greater.
- Have cirrhosis of the liver.
- Have previous surgery that removed lymphatic lower leg tissue.
- Have a diagnosis of lower limb lymphedema.
- Be pregnant or planning to become pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Transcutaneous Electrical Nerve Stimulation for Peripheral Edema: A Single Arm Clinical Trial
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.
Read the detailed description
This study is single center, subject will receive a wireless TENS device. The coordinator will introduce the study device, be available to answer questions about the device, and assess adverse events. Subjects will be told that we are testing whether TENS, which has shown promise in some patients but needs to be tested formally, has an effects on lower limb swelling . The treatment period will be 3 weeks in duration. After the treatment period, all subjects will be asked to complete the Treatment-period Endpoint-Qualitative interview. All subjects will be allowed to keep the commercially-available device for use after the study.
- Conditions
- Peripheral Edema
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
Quell TENS device. The device is worn on the upper calf right below the knee and secured by an elastic band. The device is controlled by an App and alternates between treatment periods and rest periods. Participants will be asked to wear the device 7-8 hours per day alternating legs.
| Study group | Role | What they receive |
|---|---|---|
| TENS device | Experimental | The device is worn on the upper calf right below the knee and secured by an elastic band. The device is controlled by an App and alternates between treatment periods and rest periods. Participants will be asked to wear the device 7-8 hours per day alternating legs. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Edema Symptom Diary Score
Swelling and symptoms associated with edema will be recorded in the Edema Symptom Diary using a verbal rating scale of swelling in the lower limbs and feet using the anchors "none", "a little bit", "quite a bit" "a lot", or "very much", which converts to a 1 to 5 measurable scale, with [1 = none, 5 = very much]. The scores per each symptom per day will be summed and averaged over 7 days. The higher the score the worse the health outcome. The range of scores the participant can achieve per day is between 6 - 30.
Measured: From baseline visit (Day 0) to final endpoint visit (Day 21)
Secondary outcomes (3)
Mean Change in Coordinator Tape Measurements of the Lower Limb
The blinded coordinator measures the arch of the foot, the midpoint between the kneecap and ankle, and the knee crease on both limbs, regardless of which is more affected. These measurements are recorded in the Coordinator Lower Limb Swelling form. For analysis, the individual measurements are summed for each visit, and the average of these sums across relevant records is calculated separately for baseline and final endpoint visits to assess changes over time.
Measured: From baseline visit (Day 0) to final endpoint visit (Day 21)
Mean Change in Patient Global Impression of Change in Edema Symptoms Score
The Patient Global Impression of Change in Edema Symptoms (PGIC-Edema) form contains multiple items, each rated on a 1-7 scale, with 1 = "very much improved," 4 = "not changed," and 7 = "very much worse." The total score is the sum of all item scores, with a possible range of 0-105. Higher scores indicate worse edema symptoms. For each participant, the baseline total score and final endpoint total score (Day 21) were calculated, and mean change was defined as the value at the final endpoint visit minus the value at the baseline visit.
Measured: Baseline visit (Day 0) and final endpoint visit (Day 21)
Mean Change in Lymphoedema Quality of Life Questionnaire (LYMQOL) Score
The Lymphoedema Quality of Life Questionnaire (LYMQOL) contains 26 items, each scored on a 0-4 scale, where 0 = "not at all" and 4 = "very much." Higher scores indicate worse quality of life. The total score is the sum of all item scores, with a possible range of 0-104. For each participant, the baseline total score and final endpoint total score (Day 21) were calculated, and mean change was defined as the value at the final endpoint visit minus the value at the baseline visit.
Measured: Baseline visit (Day 0) and final endpoint visit (Day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start28 Jun 2021
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Why it stopped: Terminated early due to lack of time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroMetrix, Inc.
- Responsible party
- Principal investigator, Jennifer Gewandter, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680533
- Sponsor's protocol ID
- STUDY00005655
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2020
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation for Peripheral Edema: A Single Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT04680533
- Acronym / sponsor ID
- STUDY00005655
- Conditions
- Peripheral Edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early due to lack of time.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- NeuroMetrix, Inc.
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Posted 3 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is single center, subject will receive a wireless TENS device. The coordinator will introduce the study device, be available to answer questions about the device, and assess adverse events. Subjects will be told that we are testing whether TENS, which has shown promise in some patients but needs to be tested formally, has an effects on lower limb swelling . The treatment period will be 3 weeks in duration. After the treatment period, all subjects will be asked to complete the Treatment-period Endpoint-Qualitative interview. All subjects will be allowed to keep the commercially-available device for use after the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm
| Arm | Type | Receives |
|---|---|---|
| TENS device | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)The device is worn on the upper calf right below the knee and secured by an elastic band. The device is controlled by an App and alternates between treatment periods and rest periods. Participants will be asked to wear the device 7-8 hours per day alternating legs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (15 listed)
- Be currently using a TENS device for any reason.
- Have an acute and symptomatic lower extremity DVT (i.e., the diagnosis of DVT is less than 3 months prior to study enrollment).
- Have started anticoagulants within the past 3 months.
- Have lower extremity wounds or ulcers.
- Have a cardiac pace maker or defibrillator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS)Quell TENS device. The device is worn on the upper calf right below the knee and secured by an elastic band. The device is controlled by an App and alternates between treatment periods and rest periods. Participants will be asked to wear the device 7-8 hours per day alternating legs. | Device | TENS device |
Primary outcome
Mean Change in Edema Symptom Diary Score
Time frame: From baseline visit (Day 0) to final endpoint visit (Day 21)
Swelling and symptoms associated with edema will be recorded in the Edema Symptom Diary using a verbal rating scale of swelling in the lower limbs and feet using the anchors "none", "a little bit", "quite a bit" "a lot", or "very much", which converts to a 1 to 5 measurable scale, with [1 = none, 5 = very much]. The scores per each symptom per day will be summed and averaged over 7 days. The higher the score the worse the health outcome. The range of scores the participant can achieve per day is between 6 - 30.
3 secondary outcomes
Mean Change in Coordinator Tape Measurements of the Lower Limb
Time frame: From baseline visit (Day 0) to final endpoint visit (Day 21)
Mean Change in Patient Global Impression of Change in Edema Symptoms Score
Time frame: Baseline visit (Day 0) and final endpoint visit (Day 21)
Mean Change in Lymphoedema Quality of Life Questionnaire (LYMQOL) Score
Time frame: Baseline visit (Day 0) and final endpoint visit (Day 21)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Peripheral Edema
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Peripheral Edema, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Edema Symptom Diary Score (time frame: From baseline visit (Day 0) to final endpoint visit (Day 21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.