Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People

University of Castilla-La Mancha

Status: Completed

Conditions: Electric Stimulation Therapy

Treatments: Device: Care protocol plus microcurrents; Device: Care protocol plus placebo microcurrents

Study type: Interventional

Funder types: Other

Identifiers

NCT03753581

EUEYF

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults over 60 institutionalized in nursing homes.
• Participants presenting pressure ulcers in phase II, III and IV according to the North American National Pressure Ulcer Advisory Panel System and the European Pressure Ulcer Advisory Panel System.
• Time of evolution of the pressure ulcer greater than 1 month and less than 24 months.
• Ulcer size greater than 1 cm2.
• Less than 14 points on the Braden scale.

Exclusion criteria

• Presence of a pacemaker or any implanted electrical device.
• Metal implants in the pressure ulcer area.
• Pressure ulcer in occipital area.
• Cancer.
• Osteomyelitis.
• 3 or more abnormal blood values at the beginning of the study that indicate a limited healing potential (anemia, iron deficiency, protein deficiency, dehydration, uncontrolled diabetes or hypothyroidism)
• Allergies to the usual cures protocol established.
• Systemic infection
• Recent history (minimum of 30 days) of treatment with growth factors or vacuum-assisted treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Care protocol plus microcurrents

Experimental group

Description:

* Standardized protocol of nursing care: postural treatment plus standardized cure. * Intervention with microcurrents: application of 2 electrodes (Mc Patch, Newmark USA) around the ulcer.

Treatment:

Device: Care protocol plus microcurrents

Care protocol plus placebo microcurrents

Placebo Comparator group

Description:

* Standardized protocol of nursing care: postural treatment plus standardized cure. * Placebo microcurrents: application of 2 electrodes (Mc Patch, Newmark USA) around the ulcer previously handled that do not emit current.

Treatment:

Device: Care protocol plus placebo microcurrents