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Comfort and Safety of Electrical Stimulation for Prevention of Decubitus

Comfort and Safety of Electrical Stimulation for Prevention of Decubitus - Comfort and Safety of Electrical Stimulation in Decubitus

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32663
Enrollment
25
Registered
2010-02-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decubitus

Interventions

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 n

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)