Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People
- Conditions
- Electric Stimulation Therapy
- Interventions
- Device: Care protocol plus microcurrentsDevice: Care protocol plus placebo microcurrents
- Registration Number
- NCT03753581
- Lead Sponsor
- University of Castilla-La Mancha
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Care protocol plus microcurrents 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. Care protocol plus placebo microcurrents 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.
- Primary Outcome Measures
Name Time Method Ulcer healing 1 day before the intervention start 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.Ulcer healing at 26 days 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.Ulcer healing at 14 days 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.
- Secondary Outcome Measures
Name Time Method Administration of analgesic drugs at 14 days At 14 days after the start of the intervention The type of analgesic will be registered according to WHO therapeutic steps
Ulcer área 1 day before the intervention start 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)
Ulcer área at 26 days 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)
Cutaneous blood flow in the area surrounding the pressure ulcer at 26 days 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)
Stage of pressure ulcer at 14 days 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
Cutaneous blood flow in the area surrounding the pressure ulcer 1 day before the intervention start 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)
Pain caused by pressure ulcer at 14 days: numerical scale 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)
Stage of pressure ulcer at 26 days 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
Ulcer depth 1 day before the intervention start 1 day before the start of the intervention It will be registered in mm with a Swab, specimen collection. Deltalab, SL
Pain caused by pressure ulcer at 26 days: numerical scale 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)
Stage of pressure ulcer 1 day before the intervention start 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
Pain caused by pressure ulcer 1 day before the intervention start: numerical scale 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)
Exudate culture of the ulcer 1 day before the intervention start 1 day before the start of the intervention The presence of infection in the ulcer will be evaluated with a exudate culture
Administration of systemic antibiotics 1 day before the intervention start 1 day before the start of the intervention The administration of antibiotics will be recorded
Administration of systemic antibiotics at 26 days At 26 days after the start of the intervention The administration of antibiotics will be recorded
Ulcer depth at 14 days At 14 days after the start of the intervention It will be registered in mm with a Swab, specimen collection. Deltalab, SL
Ulcer área at 14 days 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)
Cutaneous blood flow in the area surrounding the pressure ulcer at 14 days 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)
Administration of analgesic drugs at 26 days At 26 days after the start of the intervention The type of analgesic will be registered according to WHO therapeutic steps
Exudate culture of the ulcer at 26 days At 26 days after the start of the intervention The presence of infection in the ulcer will be evaluated with a exudate culture
Blood pressure 1 day before the intervention start 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
Blood pressure at 26 days 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
Capillary blood glucose at 14 days 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
Capillary blood glucose at 26 days 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
Ulcer depth at 26 days At 26 days after the start of the intervention It will be registered in mm with a Swab, specimen collection. Deltalab, SL
Administration of analgesic drugs 1 day before the intervention start 1 day before the start of the intervention The type of analgesic will be registered according to WHO therapeutic steps
Exudate culture of the ulcer at 14 days At 14 days after the start of the intervention The presence of infection in the ulcer will be evaluated with a exudate culture
Administration of systemic antibiotics at 14 days At 14 days after the start of the intervention The administration of antibiotics will be recorded
Blood pressure at 14 days 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
Capillary blood glucose 1 day before the intervention start 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
Trial Locations
- Locations (1)
Juan Avendaño-Coy
🇪🇸Toledo, Spain