Ceramide Containing Multivesicular Emulsion Application . . .

April 18, 2011 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease transepidermal water loss and foot dryness in study subjects.
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

July 27, 2009

First Submitted That Met QC Criteria

July 27, 2009

First Posted (Estimate)

July 28, 2009

Study Record Updates

Last Update Posted (Estimate)

April 20, 2011

Last Update Submitted That Met QC Criteria

April 18, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK7676 (completed)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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