FOOTNCT03932747
Creams With or Without Urea Influence the Hydration of the Skin of the Foot
A study testing pre- Hydratión skin and post- Hydratión skin in people with FOOT, run by University of Extremadura at 1 site in Spain.
Trial summary
The skin is the most external organ of our body and one of its main functions is to provide protection in terms of possible infections. Hydration is related to the proper functioning of the skin, being more difficult the appearance of wounds or cracks, which lead to the appearance of infections or other dermatological… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- FOOT
- What is being tested?
- pre- Hydratión skin and post- Hydratión skin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2019to 1 Mar 2019
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- those people who want to voluntarily participate in the study.
Who cannot join
- suffer from structural, functional or traumatic alterations that affect the morphology and function of the lower limb
- who do not fall within the age range of the study
- who have used creams or any type of lotion the night before on the feet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo-Contolled, Randomized of Creams With or Without Urea Influenceon the Hydration of the Skin of the Foot
The skin is the most external organ of our body and one of its main functions is to provide protection in terms of possible infections.
Hydration is related to the proper functioning of the skin, being more difficult the appearance of wounds or cracks, which lead to the appearance of infections or other dermatological alterations.
The skin of the feet is thicker than in the rest of the body, due to the load it supports, being more complicated to maintain it.
With this study what is intended is to assess the effectiveness of different concentrations of urea (5% and 20%) in the hydration of the foot
Read the detailed description
The measuring device of the Corneometer is constituted by a cylindrical probe, which contains at its distal end two parallel circuits in the form of capacitors covered by a plastic membrane. The probe should be placed perpendicularly on the surface of the skin. The pressure exerted on it must always be the same, therefore the probe has an internal hydraulic mechanism that, regardless of the pressure exerted by the manipulator, maintains a constant pressure.
Once the probe is placed in the place of measurement and the pressure is exerted on the skin, the circuit is closed and the conductance or capacitance is determined depending on the device, in a fraction of a second. Usually, between 3 and 10 measurements are made for each determination and entered in a computer record to obtain their averages.
The capacity of the condenser depends on the material, most of the materials increase the capacity compared to the vacuum by a factor of more than seven (dielectric constant); Water, however, increases the capacity by a factor of 81. Therefore, variations in the water content in the skin produce strong modifications in the measuring range of the Corneometer CM 825.
The Corneometer uses relative units proportional to the degree of corneal wetting. One AU corresponds to 0.2-0.9 mg of water per mg of anhydrous stratum corneum.
The study will be carried out to young people (20 -26 years old) from Practicum I of the Podiatry Clinic University of Plasencia.
The inclusion criteria will be those people who want to voluntarily participate in the study.
Those who suffer from structural, functional or traumatic alterations that affect the morphology and function of the lower limb, disorders that affect the skin, wounds, blisters are excluded from the study. Those who do not fall within the age range of the study and who have used creams or any type of lotion the night before on the feet are also excluded.
First, three randomized groups are performed, since each group will be treated with a different cream: placebo, 5% urea cream and 20% cream. The investigator will be blinded as well as the patients, since neither will know what cream is being applied.
Secondly, the subjects participating in the study will be explained, the objectives of the study and that for this need to perform a test using a non-invasive instrument that allows us to detect the superficial hydration of participants skin.
Thirdly, instructed to sign the informed consent, if so, participants are asked to accompany us to a previously heated room and be accommodated in the podiatric chair.
Subsequently, the patient is asked to answer some questions (Age, Name and surname). In addition, the researcher will note the temperature and humidity in which the room is located and the presence of hyperkeratosis on the sole of the patient's foot and area of appearance. (Annex 3)
Finally, before proceeding to the measurement, the patient is positioned barefoot with the legs stretched over the legs, then the researcher passes a gauze impregnated in alcohol of 70% to eliminate possible remains that could interfere with the measurement.
After checking that the alcohol has evaporated, explore the sole of the foot and mark on our data collection sheet, if at the points where participants are going to measure there is a presence or not of hyperkeratosis.
In this case is going to measure 3 points of each foot that are:
- First metatarsal head
- Fifth metatarsal head
- Heel
These points are considered important because they serve as support for the foot when the subject is standing, since they form the three basic points of foot support.
To carry out the hydration measurement, the investigators place the probe or head of the Corneometer on the surface of the skin and exert pressure until the appearance of an acoustic signal that indicates that the measurement has been recorded. This process is done 3 times in each zone that they want to measure to obtain 3 records and thus reduce the margin of error derived from the measurement.
To finish, the investigators will apply cream (placebo, urea 5% or 20%) depending on the study group to which it belongs, and they will fit him and the investigators will measure again in about three hours, taking the hydration of the three points mentioned above.
Once all the data of the participants have been registered, and the measurements coming from the hydration, the resulting values are analyzed.
- Conditions
- FOOT
- Being tested
- pre- Hydratión skin, post- Hydratión skin
- Keywords
- Hydration, UREA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre- Hydratión skinOther
Measurement of hydration of the skin.
post- Hydratión skinOther
Measurement of hydration of the skin.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Creams | Placebo comparator | Measuring the skin before the application of the cream without urea (placebo), wait 3 hours and re-measure the hydration Receives: Other: pre- Hydratión skin; Other: post- Hydratión skin |
| Urea 5% | Active comparator | Measuring the skin before the application of the cream with urea (5%), wait 3 hours and re-measure the hydration Receives: Other: pre- Hydratión skin; Other: post- Hydratión skin |
| Urea 20% | Active comparator | Measuring the skin before the application of the cream with urea (20%), wait 3 hours and re-measure the hydration Receives: Other: pre- Hydratión skin; Other: post- Hydratión skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-hydration of the study areas
Measurement of the hydration of the three study areas (first metatarsal head, fifth metatarsal head and heel). The measure that the corneometer gives us is UA (water per mg stratum corneum)
Measured: 5 minutes
Pre and Post of all study areas
Measurement of the hydration of the three study areas (first metatarsal head, fifth metatarsal head and heel) after the application of the different creams. The measure that the corneometer gives us is UA (water per mg stratum corneum).
Measured: 5 MINUTES
Comparison of hydration of study areas in placebo vs. 5% groups as determined using corneometer UA (water per mg stratum corneum)
It is compared if the hydration of the different study areas depending on the type of cream that has been used.
Measured: 3 hours after the application
Comparison of hydration of study areas in placebo vs. 20% groups as determined using corneometer UA (water per mg stratum corneum)
It is compared if the hydration of the different study areas depending on the type of cream that has been used.
Measured: 3 hours after the application
Comparison of hydration of study areas in 20% vs. 5% groups as determined using corneometer UA (water per mg stratum corneum)
It is compared if the hydration of the different study areas depending on the type of cream that has been used.
Measured: 3 hours after the application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start10 Jan 2019
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FOOTStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CLINICAL TRIAL WITH THREE GROUPS: CONTROL GROUP, UREA GROUP 5% AND UREA GROUP 20%.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PAULA COBOS MORENO, University of Extremadura
- Investigators
- BEATRIZ GOMEZ MARTIN, PODOLOGÍA, Study director, CENTRO UNIVERSITARIO DE PLASENCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932747
- Sponsor's protocol ID
- EXAMPLE-1
- Status last verified
- May 2019
- First submitted
- 8 Apr 2019
- Last updated
- 3 May 2019
- 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 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Contolled, Randomized of Creams With or Without Urea Influenceon the Hydration of the Skin of the Foot
- ClinicalTrials.gov ID
- NCT03932747
- Acronym / sponsor ID
- EXAMPLE-1
- Conditions
- FOOT
- Keywords
- Hydration, UREA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 1 May 2019 (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 skin is the most external organ of our body and one of its main functions is to provide protection in terms of possible infections.
Hydration is related to the proper functioning of the skin, being more difficult the appearance of wounds or cracks, which lead to the appearance of infections or other dermatological alterations.
The skin of the feet is thicker than in the rest of the body, due to the load it supports, being more complicated to maintain it.
With this study what is intended is to assess the effectiveness of different concentrations of urea (5% and 20%) in the hydration of the foot
Detailed description
The measuring device of the Corneometer is constituted by a cylindrical probe, which contains at its distal end two parallel circuits in the form of capacitors covered by a plastic membrane. The probe should be placed perpendicularly on the surface of the skin. The pressure exerted on it must always be the same, therefore the probe has an internal hydraulic mechanism that, regardless of the pressure exerted by the manipulator, maintains a constant pressure.
Once the probe is placed in the place of measurement and the pressure is exerted on the skin, the circuit is closed and the conductance or capacitance is determined depending on the device, in a fraction of a second. Usually, between 3 and 10 measurements are made for each determination and entered in a computer record to obtain their averages.
The capacity of the condenser depends on the material, most of the materials increase the capacity compared to the vacuum by a factor of more than seven (dielectric constant); Water, however, increases the capacity by a factor of 81. Therefore, variations in the water content in the skin produce strong modifications in the measuring range of the Corneometer CM 825.
The Corneometer uses relative units proportional to the degree of corneal wetting. One AU corresponds to 0.2-0.9 mg of water per mg of anhydrous stratum corneum.
The study will be carried out to young people (20 -26 years old) from Practicum I of the Podiatry Clinic University of Plasencia.
The inclusion criteria will be those people who want to voluntarily participate in the study.
Those who suffer from structural, functional or traumatic alterations that affect the morphology and function of the lower limb, disorders that affect the skin, wounds, blisters are excluded from the study. Those who do not fall within the age range of the study and who have used creams or any type of lotion the night before on the feet are also excluded.
First, three randomized groups are performed, since each group will be treated with a different cream: placebo, 5% urea cream and 20% cream. The investigator will be blinded as well as the patients, since neither will know what cream is being applied.
Secondly, the subjects participating in the study will be explained, the objectives of the study and that for this need to perform a test using a non-invasive instrument that allows us to detect the superficial hydration of participants skin.
Thirdly, instructed to sign the informed consent, if so, participants are asked to accompany us to a previously heated room and be accommodated in the podiatric chair.
Subsequently, the patient is asked to answer some questions (Age, Name and surname). In addition, the researcher will note the temperature and humidity in which the room is located and the presence of hyperkeratosis on the sole of the patient's foot and area of appearance. (Annex 3)
Finally, before proceeding to the measurement, the patient is positioned barefoot with the legs stretched over the legs, then the researcher passes a gauze impregnated in alcohol of 70% to eliminate possible remains that could interfere with the measurement.
After checking that the alcohol has evaporated, explore the sole of the foot and mark on our data collection sheet, if at the points where participants are going to measure there is a presence or not of hyperkeratosis.
In this case is going to measure 3 points of each foot that are:
- First metatarsal head
- Fifth metatarsal head
- Heel
These points are considered important because they serve as support for the foot when the subject is standing, since they form the three basic points of foot support.
To carry out the hydration measurement, the investigators place the probe or head of the Corneometer on the surface of the skin and exert pressure until the appearance of an acoustic signal that indicates that the measurement has been recorded. This process is done 3 times in each zone that they want to measure to obtain 3 records and thus reduce the margin of error derived from the measurement.
To finish, the investigators will apply cream (placebo, urea 5% or 20%) depending on the study group to which it belongs, and they will fit him and the investigators will measure again in about three hours, taking the hydration of the three points mentioned above.
Once all the data of the participants have been registered, and the measurements coming from the hydration, the resulting values are analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- CLINICAL TRIAL WITH THREE GROUPS: CONTROL GROUP, UREA GROUP 5% AND UREA GROUP 20%.
| Arm | Type | Receives |
|---|---|---|
| Placebo Creams | Placebo comparator | Other: pre- Hydratión skin, Other: post- Hydratión skinMeasuring the skin before the application of the cream without urea (placebo), wait 3 hours and re-measure the hydration |
| Urea 5% | Active comparator | Other: pre- Hydratión skin, Other: post- Hydratión skinMeasuring the skin before the application of the cream with urea (5%), wait 3 hours and re-measure the hydration |
| Urea 20% | Active comparator | Other: pre- Hydratión skin, Other: post- Hydratión skinMeasuring the skin before the application of the cream with urea (20%), wait 3 hours and re-measure the hydration |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- those people who want to voluntarily participate in the study.
Key exclusion criteria (3 listed)
- suffer from structural, functional or traumatic alterations that affect the morphology and function of the lower limb
- who do not fall within the age range of the study
- who have used creams or any type of lotion the night before on the feet
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 |
|---|---|---|
| pre- Hydratión skinMeasurement of hydration of the skin. | Other | Placebo Creams, Urea 20%, Urea 5% |
| post- Hydratión skinMeasurement of hydration of the skin. | Other | Placebo Creams, Urea 20%, Urea 5% |
Primary outcome
Pre-hydration of the study areas
Time frame: 5 minutes
Measurement of the hydration of the three study areas (first metatarsal head, fifth metatarsal head and heel). The measure that the corneometer gives us is UA (water per mg stratum corneum)
Pre and Post of all study areas
Time frame: 5 MINUTES
Measurement of the hydration of the three study areas (first metatarsal head, fifth metatarsal head and heel) after the application of the different creams. The measure that the corneometer gives us is UA (water per mg stratum corneum).
Comparison of hydration of study areas in placebo vs. 5% groups as determined using corneometer UA (water per mg stratum corneum)
Time frame: 3 hours after the application
It is compared if the hydration of the different study areas depending on the type of cream that has been used.
Comparison of hydration of study areas in placebo vs. 20% groups as determined using corneometer UA (water per mg stratum corneum)
Time frame: 3 hours after the application
It is compared if the hydration of the different study areas depending on the type of cream that has been used.
Comparison of hydration of study areas in 20% vs. 5% groups as determined using corneometer UA (water per mg stratum corneum)
Time frame: 3 hours after the application
It is compared if the hydration of the different study areas depending on the type of cream that has been used.
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 3 May 2019.
- Individual participant dataSharing planned: No
Related trials for FOOT
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Mechanisms of Instrument-Assisted Soft Tissue Manipulation (IASTM) Force Dose-Response Effects in the Calf-Foot Region
Limited Ankle Dorsiflexion Due to Calf Muscle Tightness
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
Recruiting
Effectiveness of Pulsed Electromagnetic Field Therapy in Patients With Symptomatic Plantar Calcaneal Spurs
Calcaneal Spur
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.
BEATRIZ GOMEZ MARTIN, PODOLOGÍA study director
CENTRO UNIVERSITARIO DE PLASENCIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre- Hydratión skin and post- Hydratión skin in people with FOOT, run by University of Extremadura 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 1 inclusion and 3 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 3 May 2019. 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?
Pre-hydration of the study areas (time frame: 5 minutes). The study lists 5 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 3 May 2019.