Trial Outcomes & Findings for Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics (NCT NCT01939288)

Results Overview

Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

One day

Results posted on

2019-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 Half of recruited subjects (n=5) Neuromuscular stimulator followed by IPC	Group 2 Other half of recruited subjects (n=5) IPC followed by neuromuscular stimulator
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=5 Participants Half of recruited subjects (n=5) Neuromuscular stimulator followed by IPC	Group 2 n=5 Participants Other half of recruited subjects (n=5) IPC followed by neuromuscular stimulator	Total n=10 Participants Total of all reporting groups
Age, Continuous	27.1 years STANDARD_DEVIATION 3.8 • n=5 Participants	27.1 years STANDARD_DEVIATION 3.8 • n=7 Participants	27.1 years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: One day

Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery

Outcome measures

Outcome measures
Measure	Overall Summation n=10 Participants Grouping all subject together so that no one intervention in a certain order skews results
IPC(on) Peak Velocity Change From Baseline	6.2 cm/s Interval 0.1 to 16.5

OTHER_PRE_SPECIFIED outcome

Timeframe: One day

Outcome measures

Outcome measures
Measure	Overall Summation n=10 Participants Grouping all subject together so that no one intervention in a certain order skews results
NMES(on) Peak Velocity Change From Baseline	36.7 cm/s Interval 18.8 to 49.1

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

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 Katherine Williams

Imperial College London

Phone: 020 3311 7335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place