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?
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
None
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. This is 18% of the total number of patients
admitted on the Intensive Care, excluding the patients who have decubitus
ulcers at the moment of admitting. These patients developed decubitus grade 1 -
4 despite all kind of precautions taken, like special mattresses, frequently
turning patients to release pressure and nutritional status. The total costs of
decubitus is estimated between 84.9 miljon euro and 1.9 biljon euro in Holland
alone. 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. Before we can investigate this, we will do a
comfort and safety study of the sock and electrical stimulation.
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?
Study design
The study design is a prospective intervention study. The socks will be worn on
both feet to look at adverse events or discomfort of the sock. The right foot
of the patient will get electrical stimulation to look at adverse events or
discomfort of the electrical stimulation.
Intervention
The patient will wear both socks 1 hour a day, for 3 days. The right foot will
receive the electrical stimulation. The total time of wearing the sock and
receiving electrical stimulation will be 3 hours for each patient.
Study burden and risks
Looking at the different kind of electrical stimulation that 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.
Haaksbergerstraat 55
7513 ER Enschede
Nederland
Haaksbergerstraat 55
7513 ER Enschede
Nederland
Listed location countries
Age
Inclusion criteria
Expected stay on the vascular surgery ward for at least 3 days, excluding weekend days
Exclusion criteria
Decubitus ulcer grade 1 - 4 on the heel
Ulcer or surgical wound at the lower leg
Amputation of one or both legs
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 | NL31370.044.10 |