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Trial Outcomes & Findings for REVITIVE for the Treatment of Patients With Venous Insufficiency (NCT NCT02114307)

NCT ID: NCT02114307

Last Updated: 2019-10-10

Results Overview

Femoral vein haemodynamics is measured using ultrasound scan - Time Averaged Mean Velocity

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

0 and 6 weeks

Results posted on

2019-10-10

Participant Flow

Recruitment from vascular outpatients clinic between 20/02/2014 - 18/09/2014.

Patient stayed in the full length of the study. Chronic venous insufficiency (C2-C5 CEAP). Blood pressure \<160/100mmHg. No current foot ulceration

Participant milestones

Participant milestones
Measure
REVITIVE IX: Actual Device
Trial participants will receive the true Revitive IX device REVITIVE IX: neuromuscular electrical stimulation device
REVITIVE IX: Sham Device
Trial participants will receive a sham device REVITIVE IX: sham device
Overall Study
STARTED
11
11
Overall Study
COMPLETED
10
11
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

REVITIVE for the Treatment of Patients With Venous Insufficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Test Device
n=11 Participants
Patients received the REVITIVE IX device for 6 weeks of home usage.
Sham Device
n=11 Participants
Sham REVITIVE IX for 6 weeks of home usage.
Total
n=22 Participants
Total of all reporting groups
Age, Continuous
70.0 years
STANDARD_DEVIATION 12.4 • n=5 Participants
54.6 years
STANDARD_DEVIATION 13.7 • n=7 Participants
62.3 years
STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
8 Participants
n=7 Participants
15 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
3 Participants
n=7 Participants
7 Participants
n=5 Participants
Region of Enrollment
United Kingdom
11 participants
n=5 Participants
11 participants
n=7 Participants
22 participants
n=5 Participants

PRIMARY outcome

Timeframe: 0 and 6 weeks

Femoral vein haemodynamics is measured using ultrasound scan - Time Averaged Mean Velocity

Outcome measures

Outcome measures
Measure
REVITIVE IX: Actual Device
n=10 Participants
Trial participants will receive the true Revitive IX device REVITIVE IX: neuromuscular electrical stimulation device
REVITIVE IX: Sham Device
n=11 Participants
Trial participants will receive a sham device REVITIVE IX: neuromuscular electrical stimulation device
Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
102.4 percentage change
Standard Deviation 50
-9.1 percentage change
Standard Deviation 50

SECONDARY outcome

Timeframe: 0 and 6 weeks

Lower limb oedema measured before and after using the device at 0 and 6 weeks using a perimeter. Limb volume was measured using an optoelectronic limb volumeter. Patients using compression stockings were advised to remove stockings 2 h prior to their appointment. Measurements were taken with the patient seated and the affected leg in a horizontal position. Five readings were taken before and after device usage at Week 0 and Week 6

Outcome measures

Outcome measures
Measure
REVITIVE IX: Actual Device
n=10 Participants
Trial participants will receive the true Revitive IX device REVITIVE IX: neuromuscular electrical stimulation device
REVITIVE IX: Sham Device
n=11 Participants
Trial participants will receive a sham device REVITIVE IX: neuromuscular electrical stimulation device
Changes in Limb Swelling, Volume
week 0 prestimulation
5377 ml
Standard Deviation 1122
5107 ml
Standard Deviation 1252
Changes in Limb Swelling, Volume
week 0 poststimulation
5422 ml
Standard Deviation 1127
5208 ml
Standard Deviation 1252
Changes in Limb Swelling, Volume
week 6 prestimulation
5500 ml
Standard Deviation 1173
5143 ml
Standard Deviation 1269
Changes in Limb Swelling, Volume
week 6 post stimulation
5553 ml
Standard Deviation 1168
5203 ml
Standard Deviation 1272

SECONDARY outcome

Timeframe: 0 and 6 weeks

Change in clinical symptoms as assessed by the Venous Clinical Severity Score (VCSS) from 0 to 6 weeks, lower score means improvement. Maximum score on VCSS is 30. Minimum score is 0.

Outcome measures

Outcome measures
Measure
REVITIVE IX: Actual Device
n=11 Participants
Trial participants will receive the true Revitive IX device REVITIVE IX: neuromuscular electrical stimulation device
REVITIVE IX: Sham Device
n=10 Participants
Trial participants will receive a sham device REVITIVE IX: neuromuscular electrical stimulation device
Clinical Symptoms
-11.8 Percentage change in VCSS score
Standard Deviation 31.2
6.4 Percentage change in VCSS score
Standard Deviation 20.7

Adverse Events

REVITIVE IX: Actual Device

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

REVITIVE IX: Sham 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

Dr Tristan Lane

Imperial College London

Phone: 02033117317

Results disclosure agreements

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