Trial Outcomes & Findings for Electrical Stimulation in Diabetic Peripheral Neuropathy (NCT NCT02082145)

NCT ID: NCT02082145

Last Updated: 2020-10-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: Baseline, 10 weeks
• Results posted on: 2020-10-27

Participant Flow

Participant milestones

Measure	Control Treated according to local protocol for diabetic peripheral neuropathy	NMES Treated with neuromuscular stimulation of both legs for 10 weeks
Overall Study STARTED	5	9
Overall Study COMPLETED	5	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Control n=5 Participants Treated according to local protocol for diabetic peripheral neuropathy	NMES n=9 Participants Treated with neuromuscular stimulation of both legs for 10 weeks	Total n=14 Participants Total of all reporting groups
Age, Continuous	70.6 years STANDARD_DEVIATION 1 • n=5 Participants	65.8 years STANDARD_DEVIATION 1 • n=9 Participants	69 years STANDARD_DEVIATION 1 • n=14 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=9 Participants	5 Participants n=14 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	8 Participants n=9 Participants	9 Participants n=14 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	5 participants n=5 Participants	9 participants n=9 Participants	14 participants n=14 Participants
Insulin dependance	4 participants n=5 Participants	5 participants n=9 Participants	9 participants n=14 Participants

PRIMARY outcome

Timeframe: Baseline, 10 weeks

Outcome measures

Measure	Control (Week 0) n=3 Participants week 0 - Treated according to local protocol for diabetic peripheral neuropathy	Control (Week 10) n=3 Participants week 10 - Treated according to local protocol for diabetic peripheral neuropathy	NMES (Week 0) n=3 Participants week 0 - Treated with neuromuscular stimulation of both legs	NMES (Week 10) n=3 Participants week 10 - Treated with neuromuscular stimulation of both legs
Nerve Conduction Speed (Common Peroneal Nerve)	33.93 m/sec Standard Deviation 29.4	44.1 m/sec Standard Deviation 3.2	41.63 m/sec Standard Deviation 0.5	44.13 m/sec Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline, 10 weeks

PAID (Problem Areas in Diabetes) is a self-administered 20-item scale. Each item is scored from 0 (not a problem) to 4 (serious problem). The sum of all item scores multiplied by 1.25 gives the total PAID score, which ranges from 0 to 100, higher scores reflecting greater emotional distress.

Outcome measures

Measure	Control (Week 0) n=5 Participants week 0 - Treated according to local protocol for diabetic peripheral neuropathy	Control (Week 10) n=5 Participants week 10 - Treated according to local protocol for diabetic peripheral neuropathy	NMES (Week 0) n=8 Participants week 0 - Treated with neuromuscular stimulation of both legs	NMES (Week 10) n=3 Participants week 10 - Treated with neuromuscular stimulation of both legs
PAID - Quality of Life Questionnaires	26.2 score on a scale Standard Deviation 21.23	27.4 score on a scale Standard Deviation 21.93	40.29 score on a scale Standard Deviation 17.94	5 score on a scale Standard Deviation 4.24

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NMES

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Miss Kate Williams

Imperial College London

Email: k.williams@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place