N/A
N=10
Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices
Venous Stasis · Deep Vein Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT03420625 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Blood Flow - Peak Systolic Velocity (cm/Sec) — 14.1; 29.5; 161.6; 39.0 cm/s
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Foot IPC (Device); Rapid calf IPC (Device); Slow calf IPC (Device); Calf NMES (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Karolinska University Hospital
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Flow - Peak Systolic Velocity (cm/Sec) |
14.1; 29.5; 161.6; 39.0; 42.1 | — |
| PRIMARY Blood Flow - Time-averaged Mean Velocity (cm/Sec) |
4.58; 6.53; 13.24; 7.12; 9.18 | — |
| PRIMARY Blood Flow - Volume Flow (ml/Min) |
219; 309; 604; 345; 410 | — |
| PRIMARY Blood Flow - Ejected Volume Per Individual Stimulus (ml) |
5.5; 9.4; 19.8; 60.8; 13.6 | — |
| SECONDARY Tolerability to IPC and NMES According to Visual Analogue Scale 0-10 |
6.13; 6.3; 8.0; 3.3 | — |
Summary
In this study, four different devices which stimulate the blood in the lower extremities are used in ten healthy persons while measuring the blood flow with ultrasound. The aim is to study the haemodynamic effects in the lower extremities of each modality and also to compare those effects between the four modalities in order to identify those which most effective than the others.
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers
Exclusion Criteria
- pregnancy
- previous lower limb operation involving the vascular system
- current thromboprophylactic or thrombolytic therapy
- vascular abnormalities in the lower limbs
- cardiorespiratory or renal failure causing pitting oedema
Data sourced from ClinicalTrials.gov (NCT03420625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.