Trial Outcomes & Findings for Wireless TENS for Peripheral Edema (Lower Limb Swelling) (NCT NCT04680533)

Last Updated: 2025-12-03

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

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

Results posted on

2025-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.
Overall Study Screen failure	1

Baseline Characteristics

One subject did not answer the question, so only 2 responses were entered out of 3 subjects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TENS Device n=3 Participants 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. 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.
Age, Categorical <=18 years	0 Participants n=2 Participants • One subject did not answer the question, so only 2 responses were entered out of 3 subjects.
Age, Categorical Between 18 and 65 years	1 Participants n=2 Participants • One subject did not answer the question, so only 2 responses were entered out of 3 subjects.
Age, Categorical >=65 years	1 Participants n=2 Participants • One subject did not answer the question, so only 2 responses were entered out of 3 subjects.
Sex: Female, Male Female	3 Participants n=3 Participants
Sex: Female, Male Male	0 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants
Race (NIH/OMB) Asian	0 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	0 Participants n=3 Participants
Race (NIH/OMB) White	3 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants
Region of Enrollment United States	3 Participants n=3 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	TENS device n=2 Participants 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. 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.
Mean Change in Edema Symptom Diary Score	-5.5 score on a scale Standard Deviation 1.5

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	TENS device n=2 lower limbs 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. 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.
Mean Change in Coordinator Tape Measurements of the Lower Limb Mean Baseline	236.5 CM Standard Deviation 9.5
Mean Change in Coordinator Tape Measurements of the Lower Limb Mean Final Endpoint	230.6 CM Standard Deviation 0

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	TENS device n=2 Participants 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. 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.
Mean Change in Patient Global Impression of Change in Edema Symptoms Score	53 score on a scale Standard Deviation 6

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	TENS device n=2 Participants 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. 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.
Mean Change in Lymphoedema Quality of Life Questionnaire (LYMQOL) Score Mean Baseline	36 score on a scale Standard Deviation 2
Mean Change in Lymphoedema Quality of Life Questionnaire (LYMQOL) Score Mean Final Endpoint	38 score on a scale Standard Deviation 11

Adverse Events

TENS device

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TENS device n=3 participants at risk 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. 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.
Skin and subcutaneous tissue disorders contact dermatitis	33.3% 1/3 • from enrollment until end of follow-up, up to 2 months
Nervous system disorders Vertigo	33.3% 1/3 • from enrollment until end of follow-up, up to 2 months

Additional Information

Jennifer Gewandter

University of Rochester

Phone: (585) 276-5661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place