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Completed

NCT Number: NCT03753581

Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People

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.

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Key information

Conditions

Electric Stimulation Therapy Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juan Avendaño-Coy

Toledo, 45071, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Care protocol plus microcurrents

Device

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.

Care protocol plus placebo microcurrents

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Collaborators

  • Residencia Geriátrica San Diego, S.L.
  • Residencia de Mayores Río Tajo ARTEVIDA. Centro Serviger Talavera

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 27, 2018
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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