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

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: Completed
• Conditions: Electric Stimulation Therapy
• Intervention / Treatment: Device: Care protocol plus microcurrents; Device: Care protocol plus placebo microcurrents

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Ulcer healing 1 day before the intervention start	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	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	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

Outcome Measure	Measure Description	Time Frame
Stage of pressure ulcer 1 day before the intervention start	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	The administration of antibiotics will be recorded	1 day before the start of the intervention
Administration of systemic antibiotics at 14 days	The administration of antibiotics will be recorded	At 14 days after the start of the intervention
Administration of systemic antibiotics at 26 days	The administration of antibiotics will be recorded	At 26 days after the start of the intervention
Blood pressure 1 day before the intervention start	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Effectiveness of blinding	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

• Sponsor: University of Castilla-La Mancha
• Collaborators: Residencia Geriátrica San Diego, S.L.; Residencia de Mayores Río Tajo ARTEVIDA. Centro Serviger Talavera
• Investigators: Study Director: Juan Avendaño Coy, PhD, University of Castilla-La Mancha

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2018
• Primary Completion (Actual): June 10, 2021
• Study Completion (Actual): June 10, 2021

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Electric Stimulation Therapy; Aged; Pressure Ulcer
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Etoposide; Cytarabine; Methotrexate
• Other Study ID 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