DESiVI
Research type
Research Study
Full title
Dosing of Electrical Stimulation in Venous Insufficiency
IRAS ID
171441
Contact name
Alun Davies
Contact email
Sponsor organisation
Research Governance Manager
Duration of Study in the UK
0 years, 7 months, 4 days
Research summary
We conducted a pilot randomised control trial, which showed that the Revitive IX electrical stimulation device improves blood circulation by causing contraction of the lower limb muscles. The trial also showed an improvement in quality of life of patients with venous disease who used the device for 30 minutes a day over 6 weeks compared to patients who received a sham device.
We are going to investigate the effect of varying the dose of electrical stimulation in three groups of patients who will receive either 60 minutes, 30 minutes or no electrical stimulation a day over 6 weeks. We will record change in blood flow, limb swelling, pain and improvements in quality of life.
This study will gain approval from the Research Ethics Committee and will be conducted in accordance with the recommendations of physicians involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later revisions.
Consent will be obtained from patients following full explanation and time for consideration. Subjects who withdraw from the trial will not be replaced as the drop out rate could potentially give us important information. Baseline data on these patients will be excluded from the analysis.
Participant confidentiality will be maintained during the trial and is registered under the Data Protection Act.
Imperial College London holds negligent harm and non-negligent harm insurance policies which apply to the trial.
The study will be subject to inspection and audit by Imperial College London under their remit as sponsor, the Study Coordination Centre and other regulatory bodies to ensure adherence to GCP.REC name
London - Stanmore Research Ethics Committee
REC reference
15/LO/0620
Date of REC Opinion
3 Jun 2015
REC opinion
Further Information Favourable Opinion