Decubitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Expected stay on the Intensive Care for at least 48 hours Braden score
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands