Pulseboot Pilot Safety and Tolerability Study (V1)
Research type
Research Study
Full title
Pilot study to evaluate the safety, tolerability and potential efficacy of the Pulseboot in patients with diabetic foot ulcers
IRAS ID
130012
Contact name
Sean Matheiken
Contact email
Sponsor organisation
The Diabetic Boot Company
Research summary
This study aims to evaluate the safety and tolerability of the ’Pulseboot’ in a small group of patients with diabetic foot ulcers under the care of a Multidisciplinary Foot Team over 4-6 weeks. Patients will be fitted with a ’Pulseboot’ - a device which will reduce the pressure on a foot wound (offloading) and reduce swelling using a small motorised bladder which inflates and deflates under the arch of the foot. The effect of the bladder simulates the natural emptying of blood vessels in the foot, which is lost with offloading devices, whether the patient is walking or sitting. The ’Pulseboot’ will be assessed for safety, wearability and effects on quality of life. The potential effects of ’Pulseboot’ will also be measured; the wound volume and foot swelling. Results from this study will provide key information on the design of further clinical trials to fully determine effectiveness of the Pulseboot, which may ultimately lead to a new effective treatment for diabetic foot ulcers.
REC name
London - Bromley Research Ethics Committee
REC reference
13/LO/1946
Date of REC Opinion
25 Feb 2014
REC opinion
Further Information Favourable Opinion