The primary objectives of this study are: 1. Will there be any adverse events, due to the electrical stimulation?2. Are the sock and the electrical stimulation comfortable for the patient?Our secondary objective is: Are there signs that electrical…
ID
Source
Brief title
Condition
- Cornification and dystrophic skin disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint is the number of occurrences of any kind of
discomfort or adverse event due to the sock or electrical stimulation.
Secondary outcome
Secondary study parameters/endpoints are the incidence of decubitus on the heel
in participating patients and the difference in incidence of decubitus between
treatment and control leg.
Background summary
Decubitus ulcers represent a major burden of sickness and reduced quality of
life for patients and their carers. In general hospital Medisch Spectrum
Twente, Holland, the incidence of decubitus developed on the Intensive Care was
123 patients in the year 2008 (18%). There have been several studies that
showed a possible positive effect of electrical stimulation on wound healing.
One of the working principles is increasing blood flow. This could mean that by
giving frequent electrical stimulation on the foot and lower leg, the blood
flow increases and thereby the amount of oxygen to the skin. Our hypothesis is
that this will help to reduce the risk of decubitus on the heel.
Study objective
The primary objectives of this study are:
1. Will there be any adverse events, due to the electrical stimulation?
2. Are the sock and the electrical stimulation comfortable for the patient?
Our secondary objective is: Are there signs that electrical stimulation will
reduce the incidence of decubitus ulcers on Intensive Care patients?
Study design
The study design is a prospective, within patients randomised controled pilot
study with randomisation between both legs of the patient. The socks will be
worn on both feet but only one foot will get electrical stimulation.
Intervention
The treatment group (one leg of the patient) will get electrical stimulation
for 1 hour a day, on Monday till Friday. The control group ( the other leg of
the patient) will wear the sock, but will not get the electrical stimulation.
Study burden and risks
Most of the decubitus ulcers occur at the Intensive Care unit. Getting a
decubitus ulcer is often painfull and can result in prolonged stay in the
hospital and more visits to the outpatient clinic after discharge. Decubitus
gives a reduction in the quality of life for the patient and his carers. It is
affecting all age groups and is costly both in terms of human suffering and use
of resources. Looking at the different kind of electrical stimulation what is
already used in the hospital (eg. TENS), the type of electrical stimulation we
are going to use is expected to be harmless, with no side effects. It is
possible that electrical stimulation can prevent decubitus by increasing the
cappilary blood flow.
Haaksbergerstraat 55
7513 ER Enschede
Nederland
Haaksbergerstraat 55
7513 ER Enschede
Nederland
Listed location countries
Age
Inclusion criteria
Expected stay on the Intensive Care for at least 48 hours
Braden score < 20
Exclusion criteria
•Decubitus ulcer grade 1 - 4 on the heel
•Ulcer at the lower leg
•Amputation of one or both legs
•Difference of more than 25% between both legs in the Ankle Brachial Index
•Systolic blood pressure at the foot > 250mmHg
•Inability to wear the sock
•Dark skin
Other exclusion criteria included any of the following medical conditions for which electrical stimulation is contraindicated { Houghton PE, Campbell KE; 2001}:
•Ventricular arrhythmia,
•Atrial fibrillation,
•Cardiac pacemaker,
•History of deep radiation therapy within the local region,
•Superficial metal ions or metal implants near the area
•Pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30737.044.09 |