Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People

June 10, 2021 updated by: University of Castilla-La Mancha

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Toledo, Spain, 45071
        • Juan Avendaño-Coy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Care protocol plus microcurrents
  • Standardized protocol of nursing care: postural treatment plus standardized cure.
  • Intervention with microcurrents: application of 2 electrodes (Mc Patch, Newmark USA) around the ulcer.
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.
Placebo Comparator: Care protocol plus placebo microcurrents
  • 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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ulcer healing 1 day before the intervention start
Time Frame: 1 day before the start of the intervention

It will be evaluated with the Pressure Ulcer Scale for Healing (PUSH). It was developed by the National Pressure Ulcer Advisory Panel (NPUAP) to monitor the change in the status of pressure ulcers over time.

The ulcer is categorized according to the surface area, exudate and type of wound tissue. A partial score is recorded for each of these ulcer characteristics:

  • Surface area (in cm2): 10 points (0 points=0 cm2; 10 points= >24 cm2)
  • Exudate amount: 3 points (0 points= none; 3 points=heavy).
  • Tissue type: 4 points (0 points= closed; 4 points= necrotic tissue).

To obtain the total score, the sub-scores are added. The minimum score is 0, which means that the ulcer is healed and the maximum score is 17, which means that the ulcer surface is greater than 24 cm2, that there is a heavy exudate and necrotic tissue.

A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing.
1 day before the start of the intervention
Ulcer healing at 14 days
Time Frame: At 14 days after the start of the intervention

It will be evaluated with the Pressure Ulcer Scale for Healing (PUSH). It was developed by the National Pressure Ulcer Advisory Panel (NPUAP) to monitor the change in the status of pressure ulcers over time.

The ulcer is categorized according to the surface area, exudate and type of wound tissue. A partial score is recorded for each of these ulcer characteristics:

  • Surface area (in cm2): 10 points (0 points=0 cm2; 10 points= >24 cm2)
  • Exudate amount: 3 points (0 points= none; 3 points=heavy).
  • Tissue type: 4 points (0 points= closed; 4 points= necrotic tissue).

To obtain the total score, the sub-scores are added. The minimum score is 0, which means that the ulcer is healed and the maximum score is 17, which means that the ulcer surface is greater than 24 cm2, that there is a heavy exudate and necrotic tissue.

A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing.
At 14 days after the start of the intervention
Ulcer healing at 26 days
Time Frame: At 26 days after the start of the intervention

It will be evaluated with the Pressure Ulcer Scale for Healing (PUSH). It was developed by the National Pressure Ulcer Advisory Panel (NPUAP) to monitor the change in the status of pressure ulcers over time.

The ulcer is categorized according to the surface area, exudate and type of wound tissue. A partial score is recorded for each of these ulcer characteristics:

  • Surface area (in cm2): 10 points (0 points=0 cm2; 10 points= >24 cm2)
  • Exudate amount: 3 points (0 points= none; 3 points=heavy).
  • Tissue type: 4 points (0 points= closed; 4 points= necrotic tissue).

To obtain the total score, the sub-scores are added. The minimum score is 0, which means that the ulcer is healed and the maximum score is 17, which means that the ulcer surface is greater than 24 cm2, that there is a heavy exudate and necrotic tissue.

A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing.
At 26 days after the start of the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stage of pressure ulcer 1 day before the intervention start
Time Frame: 1 day before the start of the intervention
According to the North American National Pressure Ulcer Advisory Panel System and the European Pressure Ulcer Advisory Panel System
1 day before the start of the intervention
Stage of pressure ulcer at 14 days
Time Frame: At 14 days after the start of the intervention
According to the North American National Pressure Ulcer Advisory Panel System and the European Pressure Ulcer Advisory Panel System
At 14 days after the start of the intervention
Stage of pressure ulcer at 26 days
Time Frame: At 26 days after the start of the intervention
According to the North American National Pressure Ulcer Advisory Panel System and the European Pressure Ulcer Advisory Panel System
At 26 days after the start of the intervention
Ulcer depth 1 day before the intervention start
Time Frame: 1 day before the start of the intervention
It will be registered in mm with a Swab, specimen collection. Deltalab, SL
1 day before the start of the intervention
Ulcer depth at 14 days
Time Frame: At 14 days after the start of the intervention
It will be registered in mm with a Swab, specimen collection. Deltalab, SL
At 14 days after the start of the intervention
Ulcer depth at 26 days
Time Frame: At 26 days after the start of the intervention
It will be registered in mm with a Swab, specimen collection. Deltalab, SL
At 26 days after the start of the intervention
Ulcer área 1 day before the intervention start
Time Frame: 1 day before the start of the intervention
It will be registered in cm2 with the application for pressure ulcer management Mobile Wound Analyzer (MOWA) for IOS Version 1.7.2011. Developer: Bello Ciro (Italy)
1 day before the start of the intervention
Ulcer área at 14 days
Time Frame: At 14 days after the start of the intervention
It will be registered in cm2 with the application for pressure ulcer management Mobile Wound Analyzer (MOWA) for IOS Version 1.7.2011. Developer: Bello Ciro (Italy)
At 14 days after the start of the intervention
Ulcer área at 26 days
Time Frame: At 26 days after the start of the intervention
It will be registered in cm2 with the application for pressure ulcer management Mobile Wound Analyzer (MOWA) for IOS Version 1.7.2011. Developer: Bello Ciro (Italy)
At 26 days after the start of the intervention
Cutaneous blood flow in the area surrounding the pressure ulcer 1 day before the intervention start
Time Frame: 1 day before the start of the intervention
It will be recorded in the greater side of the ulcer by cutaneous doppler laser flowmetry with a scale of 0-1000 units (model DRT4, Moor instruments, Devon, UK)
1 day before the start of the intervention
Cutaneous blood flow in the area surrounding the pressure ulcer at 14 days
Time Frame: At 14 days after the start of the intervention
It will be recorded in the greater side of the ulcer by cutaneous doppler laser flowmetry with a scale of 0-1000 units (model DRT4, Moor instruments, Devon, UK)
At 14 days after the start of the intervention
Cutaneous blood flow in the area surrounding the pressure ulcer at 26 days
Time Frame: At 26 days after the start of the intervention
It will be recorded in the greater side of the ulcer by cutaneous doppler laser flowmetry with a scale of 0-1000 units (model DRT4, Moor instruments, Devon, UK)
At 26 days after the start of the intervention
Pain caused by pressure ulcer 1 day before the intervention start: numerical scale
Time Frame: 1 day before the start of the intervention
It will be assessed with the numerical scale of the pain that includes the values from 0 (absence of pain) to 10 (maximum pain)
1 day before the start of the intervention
Pain caused by pressure ulcer at 14 days: numerical scale
Time Frame: At 14 days after the start of the intervention
It will be assessed with the numerical scale of the pain that includes the values from 0 (absence of pain) to 10 (maximum pain)
At 14 days after the start of the intervention
Pain caused by pressure ulcer at 26 days: numerical scale
Time Frame: At 26 days after the start of the intervention
It will be assessed with the numerical scale of the pain that includes the values from 0 (absence of pain) to 10 (maximum pain)
At 26 days after the start of the intervention
Administration of analgesic drugs 1 day before the intervention start
Time Frame: 1 day before the start of the intervention
The type of analgesic will be registered according to WHO therapeutic steps
1 day before the start of the intervention
Administration of analgesic drugs at 14 days
Time Frame: At 14 days after the start of the intervention
The type of analgesic will be registered according to WHO therapeutic steps
At 14 days after the start of the intervention
Administration of analgesic drugs at 26 days
Time Frame: At 26 days after the start of the intervention
The type of analgesic will be registered according to WHO therapeutic steps
At 26 days after the start of the intervention
Exudate culture of the ulcer 1 day before the intervention start
Time Frame: 1 day before the start of the intervention
The presence of infection in the ulcer will be evaluated with a exudate culture
1 day before the start of the intervention
Exudate culture of the ulcer at 14 days
Time Frame: At 14 days after the start of the intervention
The presence of infection in the ulcer will be evaluated with a exudate culture
At 14 days after the start of the intervention
Exudate culture of the ulcer at 26 days
Time Frame: At 26 days after the start of the intervention
The presence of infection in the ulcer will be evaluated with a exudate culture
At 26 days after the start of the intervention
Administration of systemic antibiotics 1 day before the intervention start
Time Frame: 1 day before the start of the intervention
The administration of antibiotics will be recorded
1 day before the start of the intervention
Administration of systemic antibiotics at 14 days
Time Frame: At 14 days after the start of the intervention
The administration of antibiotics will be recorded
At 14 days after the start of the intervention
Administration of systemic antibiotics at 26 days
Time Frame: At 26 days after the start of the intervention
The administration of antibiotics will be recorded
At 26 days after the start of the intervention
Blood pressure 1 day before the intervention start
Time Frame: 1 day before the start of the intervention
The systolic and diastolic blood pressure will be recorded in mm/Hg with a tensiometer. It will be taken at rest, making 2 measurements separated by a 1-2 minute interval
1 day before the start of the intervention
Blood pressure at 14 days
Time Frame: At 14 days after the start of the intervention
The systolic and diastolic blood pressure will be recorded in mm/Hg with a tensiometer. It will be taken at rest, making 2 measurements separated by a 1-2 minute interval
At 14 days after the start of the intervention
Blood pressure at 26 days
Time Frame: At 26 days after the start of the intervention
The systolic and diastolic blood pressure will be recorded in mm/Hg with a tensiometer. It will be taken at rest, making 2 measurements separated by a 1-2 minute interval
At 26 days after the start of the intervention
Capillary blood glucose 1 day before the intervention start
Time Frame: 1 day before the start of the intervention
It will be recorded in mg/dl with a glucometer, taking as a glycemia value the average of 2 measurements with an interval of 24 hours between each record
1 day before the start of the intervention
Capillary blood glucose at 14 days
Time Frame: At 14 days after the start of the intervention
It will be recorded in mg/dl with a glucometer, taking as a glycemia value the average of 2 measurements with an interval of 24 hours between each record
At 14 days after the start of the intervention
Capillary blood glucose at 26 days
Time Frame: At 26 days after the start of the intervention
It will be recorded in mg/dl with a glucometer, taking as a glycemia value the average of 2 measurements with an interval of 24 hours between each record
At 26 days after the start of the intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effectiveness of blinding
Time Frame: At 14 days after the start of the intervention
The participants, evaluators and those who apply the intervention will be asked if they know the research group to which the study subject belongs.
At 14 days after the start of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Castilla-La Mancha

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Residencia Geriátrica San Diego, S.L.
Residencia de Mayores Río Tajo ARTEVIDA. Centro Serviger Talavera

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Juan Avendaño Coy, PhD, University of Castilla-La Mancha

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EUEYF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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