Trial Outcomes & Findings for ULCERS - Electrical Stimulation in Diabetic Foot Ulceration (NCT NCT02211495)

Results Overview

Time to 50% healing of leg ulcer, as measured by volume (3D camera)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

8 weeks

Results posted on

2020-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	No Device Treated with best medical therapy Best Medical Therapy: Seen in outpatient clinic for wound care and ongoing advice	Device As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week. GEKO device: Placed on the lateral aspect of the knee, when activated it causes the leg to twitch Best Medical Therapy: Seen in outpatient clinic for wound care and ongoing advice
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
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

Baseline characteristics by cohort
Measure	No Device n=4 Participants Medical therapy	Device n=4 Participants As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.	Total n=8 Participants Total of all reporting groups
Age, Continuous	65 years n=4 Participants	69.5 years n=4 Participants	67 years n=8 Participants
Sex: Female, Male Female	2 Participants n=4 Participants	2 Participants n=4 Participants	4 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=4 Participants	2 Participants n=4 Participants	4 Participants n=8 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	4 participants n=4 Participants	4 participants n=4 Participants	8 participants n=8 Participants

PRIMARY outcome

Timeframe: 8 weeks

Time to 50% healing of leg ulcer, as measured by volume (3D camera)

Outcome measures

Outcome measures
Measure	No Device n=4 Participants Medical therapy only.	Device n=4 Participants As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.	Device (Week 0) As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. Week 0	Device (Week 6) As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week, week 6.
Number of Day Until 50% Healing of Leg Ulcer	55 Days Standard Error 5	30 Days Standard Error 5	—	—

SECONDARY outcome

Timeframe: 6 weeks

Improvement in quality of life questionnaire values, comparing baseline to 6 weeks with treatment PAID ("Problem Areas in Diabetes") - score 0-80, 0 is no problem, 80 is serious problem EQ5D (standardised instrument for generic quality of life score, https://en.wikipedia.org/wiki/EQ-5D) - combination of different dimensions of health to form an overall index, 1.0 for a perfect state of health, with 0 on the scale representing the state of being dead VAS ("visual analogue scale") - For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100) SF 12 ("short form 12") - weighted and summed to provide easily interpretable scales for physical and mental health, the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health

Outcome measures

Outcome measures
Measure	No Device n=4 Participants Medical therapy only.	Device n=4 Participants As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.	Device (Week 0) n=4 Participants As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. Week 0	Device (Week 6) n=4 Participants As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week, week 6.
Quality of Life (PAID, EQ5D, VAS, SF-12) PAID	22.8 units on a scale Standard Deviation 14	13 units on a scale Standard Deviation 1	21.2 units on a scale Standard Deviation 7	17.3 units on a scale Standard Deviation 14
Quality of Life (PAID, EQ5D, VAS, SF-12) EQ5D	.54 units on a scale Standard Deviation .4	.7 units on a scale Standard Deviation .2	.18 units on a scale Standard Deviation .4	.4 units on a scale Standard Deviation .4
Quality of Life (PAID, EQ5D, VAS, SF-12) VAS	58 units on a scale Standard Deviation 13	60 units on a scale Standard Deviation 14	37 units on a scale Standard Deviation 38	55 units on a scale Standard Deviation 23
Quality of Life (PAID, EQ5D, VAS, SF-12) SF-12	82.1 units on a scale Standard Deviation 12	67 units on a scale Standard Deviation 9	66 units on a scale Standard Deviation 14	72 units on a scale Standard Deviation 11

Adverse Events

No Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Device

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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place