Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People

NCT03753581 | Completed DMC

• 1 other identifier: EUEYF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Electric Stimulation Therapy

Keywords

Electric Stimulation Therapy; Pressure Ulcer; Aged

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (30)

• Stage of pressure ulcer 1 day before the intervention start

  1 day before the start of the intervention

• Stage of pressure ulcer at 14 days

  At 14 days after the start of the intervention

• Stage of pressure ulcer at 26 days

  At 26 days after the start of the intervention

• Ulcer depth 1 day before the intervention start

  1 day before the start of the intervention

• Ulcer depth at 14 days

  At 14 days after the start of the intervention

Other Outcomes (1)

• Effectiveness of blinding

  At 14 days after the start of the intervention

Study Arms (2)

Care protocol plus microcurrents

EXPERIMENTAL

* 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 protocol plus placebo microcurrents

PLACEBO COMPARATOR

* 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

Interventions

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 microcurrents

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

Care protocol plus placebo microcurrents

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of a pacemaker or any implanted electrical device.
• Metal implants in the pressure ulcer area.
• Pressure ulcer in occipital area.
• Cancer.
• Osteomyelitis.
• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Residencia Geriátrica San Diego, S.L.: collaborator
• Residencia de Mayores Río Tajo ARTEVIDA. Centro Serviger Talavera: collaborator

Study Sites (1)

Juan Avendaño-Coy

Toledo, 45071, Spain

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Juan Avendaño Coy, PhD

  University of Castilla-La Mancha

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Masking of the researchers: the assignment of participants to the groups will be carried out by a researcher who will not apply the interventions and will not collect the outcome variables. The interventions will be carried out by researchers different from those who will perform the evaluations of the outcome variables. Masking of the participants: it will be done using the same electrodes and microcurrent devices in both groups. In the placebo stimulation, the device will emit a luminous signal of operation as well as the devices of the intervention group, however, it will be manipulated and tested with an oscilloscope to ensure that it does not emit microcurrents. The participants of both groups will not perceive any sensation of current, since the electrical stimulation with microcurrents is below the sensitive threshold.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: November 27, 2018
• Study Start: October 31, 2018
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: June 11, 2021

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)