Comfort and Safety of Electrical Stimulation for Prevention of Decubitus
Withdrawn
- Conditions
- Decubitus10011063
- Registration Number
- NL-OMON32663
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 25
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameter/endpoint is the number of occurrences of any kind of<br /><br>discomfort or adverse event due to the sock or electrical stimulation. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters/endpoints are the incidence of decubitus on the heel<br /><br>in participating patients and the difference in incidence of decubitus between<br /><br>treatment and control leg.</p><br>