Clinical trial NCT03753581: Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People
Official title: Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People: Controlled and Randomized Triple Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electric Stimulation Therapy
Keywords: Electric Stimulation Therapy
Pressure Ulcer
Aged
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Residencia Geriátrica San Diego, S.L.
name: Residencia de Mayores Río Tajo ARTEVIDA. Centro Serviger Talavera
First posted: 2018-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Ulcer healing 1 day before the intervention start
timeFrame: 1 day before the start of the intervention
measure: Ulcer healing at 14 days
timeFrame: At 14 days after the start of the intervention
measure: Ulcer healing at 26 days
timeFrame: At 26 days after the start of the intervention
Secondary outcomes:
measure: Stage of pressure ulcer 1 day before the intervention start
timeFrame: 1 day before the start of the intervention
measure: Stage of pressure ulcer at 14 days
timeFrame: At 14 days after the start of the intervention
measure: Stage of pressure ulcer at 26 days
timeFrame: At 26 days after the start of the intervention
measure: Ulcer depth 1 day before the intervention start
timeFrame: 1 day before the start of the intervention
measure: Ulcer depth at 14 days
timeFrame: At 14 days after the start of the intervention
measure: Ulcer depth at 26 days
timeFrame: At 26 days after the start of the intervention
measure: Ulcer área 1 day before the intervention start
timeFrame: 1 day before the start of the intervention
measure: Ulcer área at 14 days
timeFrame: At 14 days after the start of the intervention
measure: Ulcer área at 26 days
timeFrame: At 26 days after the start of the intervention
measure: Cutaneous blood flow in the area surrounding the pressure ulcer 1 day before the intervention start
timeFrame: 1 day before the start of the intervention
measure: Cutaneous blood flow in the area surrounding the pressure ulcer at 14 days
timeFrame: At 14 days after the start of the intervention
measure: Cutaneous blood flow in the area surrounding the pressure ulcer at 26 days
timeFrame: At 26 days after the start of the intervention
measure: Pain caused by pressure ulcer 1 day before the intervention start: numerical scale
timeFrame: 1 day before the start of the intervention
measure: Pain caused by pressure ulcer at 14 days: numerical scale
timeFrame: At 14 days after the start of the intervention
measure: Pain caused by pressure ulcer at 26 days: numerical scale
timeFrame: At 26 days after the start of the intervention
measure: Administration of analgesic drugs 1 day before the intervention start
timeFrame: 1 day before the start of the intervention
measure: Administration of analgesic drugs at 14 days
timeFrame: At 14 days after the start of the intervention
measure: Administration of analgesic drugs at 26 days
timeFrame: At 26 days after the start of the intervention
measure: Exudate culture of the ulcer 1 day before the intervention start
timeFrame: 1 day before the start of the intervention
measure: Exudate culture of the ulcer at 14 days
timeFrame: At 14 days after the start of the intervention
measure: Exudate culture of the ulcer at 26 days
timeFrame: At 26 days after the start of the intervention
measure: Administration of systemic antibiotics 1 day before the intervention start
timeFrame: 1 day before the start of the intervention
measure: Administration of systemic antibiotics at 14 days
timeFrame: At 14 days after the start of the intervention
measure: Administration of systemic antibiotics at 26 days
timeFrame: At 26 days after the start of the intervention
measure: Blood pressure 1 day before the intervention start
timeFrame: 1 day before the start of the intervention
measure: Blood pressure at 14 days
timeFrame: At 14 days after the start of the intervention
measure: Blood pressure at 26 days
timeFrame: At 26 days after the start of the intervention
measure: Capillary blood glucose 1 day before the intervention start
timeFrame: 1 day before the start of the intervention
measure: Capillary blood glucose at 14 days
timeFrame: At 14 days after the start of the intervention
measure: Capillary blood glucose at 26 days
timeFrame: At 26 days after the start of the intervention
Other outcomes:
measure: Effectiveness of blinding
timeFrame: At 14 days after the start of the intervention
Locations:
city: Toledo
country: Spain
facility: Juan Avendaño-Coy
Study officials:
affiliation: University of Castilla-La Mancha
name: Juan Avendaño Coy, PhD
role: STUDY_DIRECTOR
References: