Wireless TENS for Peripheral Edema (Lower Limb Swelling)

NCT04680533 | Terminated Phase 1 Results FDA Device

• 1 other identifier: STUDY00005655
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Edema

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• Mean Change in Coordinator Tape Measurements of the Lower Limb

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

• Mean Change in Patient Global Impression of Change in Edema Symptoms Score

  Baseline visit (Day 0) and final endpoint visit (Day 21)

• Mean Change in Lymphoedema Quality of Life Questionnaire (LYMQOL) Score

  Baseline visit (Day 0) and final endpoint visit (Day 21)

Study Arms (1)

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.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Interventions

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.

TENS device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Rochester: lead
• NeuroMetrix, Inc.: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Jennifer Gewandter
• Organization: University of Rochester

jennifer_gewandter@urmc.rochester.edu

(585) 276-5661

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single Arm

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 23, 2020
• Study Start: June 28, 2021
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: December 3, 2025
• Results First Posted: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)