NCT03753581

Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People

Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People: Controlled and Randomized Triple Blind Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Castilla-La Mancha · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect on the healing of pressure ulcers in elderly people using a care protocol plus the application of microcurrent patches during 12 hours per day compared to the effect of the same protocol plus placebo electric stimulation.

Detailed description

The design of this study is a multicentric, parallel, randomised, triple blind clinical trial with placebo control. The size of the sample will be 30 participants older than 60 years old who are institutionalized in some nursing homes in Spain.They will be randomized in two groups: control or experimental. The variables of the study will be collected at three time points: before the intervention, 14 days after the start of the intervention and at the end of the intervention. The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two-factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with Bonferroni correction

Conditions

• Electric Stimulation Therapy

Interventions

Type	Name	Description
DEVICE	Care protocol plus microcurrents	CARE NURSING PROTOCOL: postural treatment every 4 hours more standardized cure according to the guide of recommendations based on evidence in prevention and treatment of pressure ulcers in adults of Osakidetza health service. MICROCURRENTS: the electrodes will be placed on the edge of the dressing on the sides of the ulcer's longer length during 12 hours a day until the ulcer is completely healed or for a maximum of 25 days. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.5 s and pause of 300 ms, voltage 21 mV and intensity 42μA with a current density of 4.2 μA.
DEVICE	Care protocol plus placebo microcurrents	The same nursing care protocol described for the experimental group will be applied more 12 hours per day of 2 electrodes of microcurrents around the ulcer, which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents

Timeline

• Start date: 2018-10-31
• Primary completion: 2021-06-10
• Completion: 2021-06-10
• First posted: 2018-11-27
• Last updated: 2021-06-11

Locations

1 site across 1 country: Spain