Electric Stimulation TherapyNCT03753581
Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People
A study testing Care protocol plus microcurrents in people with Electric Stimulation Therapy, run by University of Castilla-La Mancha at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Electric Stimulation Therapy
- What is being tested?
- Care protocol plus microcurrents
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 31 Oct 2018to 10 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- Allergies to the usual cures protocol established.
- Systemic infection
- Recent history (minimum of 30 days) of treatment with growth factors or vacuum-assisted treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People: Controlled and Randomized Triple Blind Clinical Trial
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.
Read the 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
- Conditions
- Electric Stimulation Therapy
- Being tested
- Care protocol plus microcurrents, Care protocol plus placebo microcurrents
- Keywords
- Electric Stimulation Therapy, Pressure Ulcer, Aged
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care protocol plus microcurrentsDevice
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 microcurrentsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Care protocol plus placebo microcurrents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At 26 days after the start of the intervention
Secondary outcomes (30)
Stage of pressure ulcer 1 day before the intervention start
According to the North American National Pressure Ulcer Advisory Panel System and the European Pressure Ulcer Advisory Panel System
Measured: 1 day before the start of the intervention
Stage of pressure ulcer at 14 days
According to the North American National Pressure Ulcer Advisory Panel System and the European Pressure Ulcer Advisory Panel System
Measured: At 14 days after the start of the intervention
Stage of pressure ulcer at 26 days
According to the North American National Pressure Ulcer Advisory Panel System and the European Pressure Ulcer Advisory Panel System
Measured: At 26 days after the start of the intervention
Ulcer depth 1 day before the intervention start
It will be registered in mm with a Swab, specimen collection. Deltalab, SL
Measured: 1 day before the start of the intervention
Ulcer depth at 14 days
It will be registered in mm with a Swab, specimen collection. Deltalab, SL
Measured: At 14 days after the start of the intervention
Ulcer depth at 26 days
It will be registered in mm with a Swab, specimen collection. Deltalab, SL
Measured: At 26 days after the start of the intervention
Ulcer área 1 day before the intervention start
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)
Measured: 1 day before the start of the intervention
Ulcer área at 14 days
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)
Measured: At 14 days after the start of the intervention
Ulcer área at 26 days
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)
Measured: At 26 days after the start of the intervention
Cutaneous blood flow in the area surrounding the pressure ulcer 1 day before the intervention start
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)
Measured: 1 day before the start of the intervention
Cutaneous blood flow in the area surrounding the pressure ulcer at 14 days
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)
Measured: At 14 days after the start of the intervention
Cutaneous blood flow in the area surrounding the pressure ulcer at 26 days
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)
Measured: At 26 days after the start of the intervention
Pain caused by pressure ulcer 1 day before the intervention start: numerical scale
It will be assessed with the numerical scale of the pain that includes the values from 0 (absence of pain) to 10 (maximum pain)
Measured: 1 day before the start of the intervention
Pain caused by pressure ulcer at 14 days: numerical scale
It will be assessed with the numerical scale of the pain that includes the values from 0 (absence of pain) to 10 (maximum pain)
Measured: At 14 days after the start of the intervention
Pain caused by pressure ulcer at 26 days: numerical scale
It will be assessed with the numerical scale of the pain that includes the values from 0 (absence of pain) to 10 (maximum pain)
Measured: At 26 days after the start of the intervention
Administration of analgesic drugs 1 day before the intervention start
The type of analgesic will be registered according to WHO therapeutic steps
Measured: 1 day before the start of the intervention
Administration of analgesic drugs at 14 days
The type of analgesic will be registered according to WHO therapeutic steps
Measured: At 14 days after the start of the intervention
Administration of analgesic drugs at 26 days
The type of analgesic will be registered according to WHO therapeutic steps
Measured: At 26 days after the start of the intervention
Exudate culture of the ulcer 1 day before the intervention start
The presence of infection in the ulcer will be evaluated with a exudate culture
Measured: 1 day before the start of the intervention
Exudate culture of the ulcer at 14 days
The presence of infection in the ulcer will be evaluated with a exudate culture
Measured: At 14 days after the start of the intervention
Exudate culture of the ulcer at 26 days
The presence of infection in the ulcer will be evaluated with a exudate culture
Measured: At 26 days after the start of the intervention
Administration of systemic antibiotics 1 day before the intervention start
The administration of antibiotics will be recorded
Measured: 1 day before the start of the intervention
Administration of systemic antibiotics at 14 days
The administration of antibiotics will be recorded
Measured: At 14 days after the start of the intervention
Administration of systemic antibiotics at 26 days
The administration of antibiotics will be recorded
Measured: At 26 days after the start of the intervention
Blood pressure 1 day before the intervention start
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
Measured: 1 day before the start of the intervention
Blood pressure at 14 days
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
Measured: At 14 days after the start of the intervention
Blood pressure at 26 days
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
Measured: At 26 days after the start of the intervention
Capillary blood glucose 1 day before the intervention start
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
Measured: 1 day before the start of the intervention
Capillary blood glucose at 14 days
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
Measured: At 14 days after the start of the intervention
Capillary blood glucose at 26 days
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
Measured: At 26 days after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start31 Oct 2018
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electric Stimulation TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Residencia Geriátrica San Diego, S.L., Residencia de Mayores Río Tajo ARTEVIDA. Centro Serviger Talavera
- Responsible party
- Sponsor
- Investigators
- Juan Avendaño Coy, PhD, Study director, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753581
- Sponsor's protocol ID
- EUEYF
- Status last verified
- Nov 2018
- First submitted
- 4 Oct 2018
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People: Controlled and Randomized Triple Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03753581
- Acronym / sponsor ID
- EUEYF
- Conditions
- Electric Stimulation Therapy
- Keywords
- Electric Stimulation Therapy, Pressure Ulcer, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Residencia Geriátrica San Diego, S.L., Residencia de Mayores Río Tajo ARTEVIDA. Centro Serviger Talavera
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care protocol plus microcurrents | Experimental | Device: 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 | Placebo comparator | Device: 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Presence of a pacemaker or any implanted electrical device.
- Metal implants in the pressure ulcer area.
- Pressure ulcer in occipital area.
- Cancer.
- Osteomyelitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care protocol plus microcurrentsCARE 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. | Device | Care protocol plus microcurrents |
| Care protocol plus placebo microcurrentsThe 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 | Device | Care protocol plus placebo microcurrents |
Primary outcome
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.
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.
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.
30 secondary outcomes
Stage of pressure ulcer 1 day before the intervention start
Time frame: 1 day before the start of the intervention
Stage of pressure ulcer at 14 days
Time frame: At 14 days after the start of the intervention
Stage of pressure ulcer at 26 days
Time frame: At 26 days after the start of the intervention
Ulcer depth 1 day before the intervention start
Time frame: 1 day before the start of the intervention
Ulcer depth at 14 days
Time frame: At 14 days after the start of the intervention
Ulcer depth at 26 days
Time frame: At 26 days after the start of the intervention
Ulcer área 1 day before the intervention start
Time frame: 1 day before the start of the intervention
Ulcer área at 14 days
Time frame: At 14 days after the start of the intervention
Ulcer área at 26 days
Time frame: At 26 days after the start of the intervention
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
Cutaneous blood flow in the area surrounding the pressure ulcer at 14 days
Time frame: At 14 days after the start of the intervention
Cutaneous blood flow in the area surrounding the pressure ulcer at 26 days
Time frame: At 26 days after the start of the intervention
Pain caused by pressure ulcer 1 day before the intervention start: numerical scale
Time frame: 1 day before the start of the intervention
Pain caused by pressure ulcer at 14 days: numerical scale
Time frame: At 14 days after the start of the intervention
Pain caused by pressure ulcer at 26 days: numerical scale
Time frame: At 26 days after the start of the intervention
Administration of analgesic drugs 1 day before the intervention start
Time frame: 1 day before the start of the intervention
Administration of analgesic drugs at 14 days
Time frame: At 14 days after the start of the intervention
Administration of analgesic drugs at 26 days
Time frame: At 26 days after the start of the intervention
Exudate culture of the ulcer 1 day before the intervention start
Time frame: 1 day before the start of the intervention
Exudate culture of the ulcer at 14 days
Time frame: At 14 days after the start of the intervention
Exudate culture of the ulcer at 26 days
Time frame: At 26 days after the start of the intervention
Administration of systemic antibiotics 1 day before the intervention start
Time frame: 1 day before the start of the intervention
Administration of systemic antibiotics at 14 days
Time frame: At 14 days after the start of the intervention
Administration of systemic antibiotics at 26 days
Time frame: At 26 days after the start of the intervention
Blood pressure 1 day before the intervention start
Time frame: 1 day before the start of the intervention
Blood pressure at 14 days
Time frame: At 14 days after the start of the intervention
Blood pressure at 26 days
Time frame: At 26 days after the start of the intervention
Capillary blood glucose 1 day before the intervention start
Time frame: 1 day before the start of the intervention
Capillary blood glucose at 14 days
Time frame: At 14 days after the start of the intervention
Capillary blood glucose at 26 days
Time frame: At 26 days after the start of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Avendaño Coy, PhD study director
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care protocol plus microcurrents in people with Electric Stimulation Therapy, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer healing 1 day before the intervention start (time frame: 1 day before the start of the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.