Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Electric Stimulation Therapy

Intervention / Treatment
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* Device: Care protocol plus microcurrents
* Device: Care protocol plus placebo microcurrents


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Care protocol plus microcurrents<br>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<br>* 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.<br>|
| Placebo Comparator: Care protocol plus placebo microcurrents<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electric Stimulation Therapy, Pressure Ulcer, Aged