Foot Transepidermal Water Loss in Patients in NIDDMNCT00947726
Ceramide Containing Multivesicular Emulsion Application . . .
A study testing CeraVe in people with Foot Transepidermal Water Loss in Patients in NIDDM and Foot Dryness in Patients With NIDDM, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Trial summary
We believe that using a ceramide based foot cream two times a day for two weeks will prevent water loss and overall foot dryness in patients with non-insulin dependent diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Transepidermal Water Loss in Patients in NIDDM, Foot Dryness in Patients With NIDDM
- What is being tested?
- CeraVe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to 31 Jul 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- non insulin-dependent diabetes
- moderate to severe xerosis of both feet [a score of at least 4 on a scale of 0 (normal) to 8 (deep fissuring)]
- capable of understanding and signing consent form
Who cannot join
- history of ichthyosis vulgaris
- known hypersensitivity to the topical product used in the study
- previous use of high potency steroids (class I and II) in past 2 week
- presence of acute skin disease or infection, such as vasculitis or cellulitis
- presence of foot ulcer
- evidence of gangrene
About this study
Official title: Ceramide Containing Multivesicular Emulsion Application as a Skin Hydration Treatment for Feet of Subjects With Non-insulin Dependent Diabetes Mellitus.
We believe that using a ceramide based foot cream two times a day for two weeks will prevent water loss and overall foot dryness in patients with non-insulin dependent diabetes.
- Being tested
- CeraVe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraVeOther
Also called Ceramide based foot cream
Using over the counter (OTC) cream on foot twice daily for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| CeraVe | Experimental | Ceramide based foot cream twice daily for two weeks Receives: Other: CeraVe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease transepidermal water loss and foot dryness in study subjects.
Measured: Baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startJul 2009
- Primary completion31 Jul 2010
- Study completion31 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Transepidermal Water Loss in Patients in NIDDMStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947726
- Sponsor's protocol ID
- DK7676 (completed)
- Other IDs
- T35DK007676
- Status last verified
- Feb 2026
- First submitted
- 27 Jul 2009
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceramide Containing Multivesicular Emulsion Application as a Skin Hydration Treatment for Feet of Subjects With Non-insulin Dependent Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT00947726
- Acronym / sponsor ID
- DK7676 (completed)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- The University of Texas Health Science Center, Houston
- Study start
- Jul 2009
- Primary completion
- 31 Jul 2010 (actual)
- Study completion
- 31 Jul 2010 (actual)
- First posted
- 28 Jul 2009 (estimated)
- 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.
We believe that using a ceramide based foot cream two times a day for two weeks will prevent water loss and overall foot dryness in patients with non-insulin dependent diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CeraVe | Experimental | Other: CeraVeCeramide based foot cream twice daily for two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years of age
- non insulin-dependent diabetes
- moderate to severe xerosis of both feet [a score of at least 4 on a scale of 0 (normal) to 8 (deep fissuring)]
- capable of understanding and signing consent form
Key exclusion criteria (6 listed)
- history of ichthyosis vulgaris
- known hypersensitivity to the topical product used in the study
- previous use of high potency steroids (class I and II) in past 2 week
- presence of acute skin disease or infection, such as vasculitis or cellulitis
- presence of foot ulcer
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 |
|---|---|---|
| CeraVeAlso: Ceramide based foot creamUsing over the counter (OTC) cream on foot twice daily for two weeks. | Other | CeraVe |
Primary outcome
Decrease transepidermal water loss and foot dryness in study subjects.
Time frame: Baseline and 5 weeks
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 20 Feb 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CeraVe in people with Foot Transepidermal Water Loss in Patients in NIDDM and Foot Dryness in Patients With NIDDM, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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 4 inclusion and 6 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 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Decrease transepidermal water loss and foot dryness in study subjects. (time frame: Baseline and 5 weeks). 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 20 Feb 2026.