Status:
COMPLETED
Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People
Lead Sponsor:
University of Castilla-La Mancha
Collaborating Sponsors:
Residencia Geriátrica San Diego, S.L.
Residencia de Mayores Río Tajo ARTEVIDA. Centro Serviger Talavera
Conditions:
Electric Stimulation Therapy
Eligibility:
All Genders
60+ years
Phase:
NA
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 co...
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 inst...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03753581
Start Date
October 31 2018
End Date
June 10 2021
Last Update
June 11 2021
Active Locations (1)
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1
Juan Avendaño-Coy
Toledo, Spain, 45071