Ceramide Containing Multivesicular Emulsion Application . . .

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00947726
First received: July 27, 2009
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Foot Transepidermal Water Loss in Patients in NIDDM
Foot Dryness in Patients With NIDDM
Drug: CeraVe

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ceramide Containing Multivesicular Emulsion Application as a Skin Hydration Treatment for Feet of Subjects With Non-insulin Dependent Diabetes Mellitus.

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Decrease transepidermal water loss and foot dryness in study subjects. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CeraVe
    Using OTC cream on foot twice daily for two weeks.
    Other Name: Ceramide based foot cream
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Adelaide A. Hebert, MD, The University of Texas Health Science Center at Houston
ClinicalTrials.gov Identifier: NCT00947726     History of Changes
Other Study ID Numbers: DK7676 (completed)
Study First Received: July 27, 2009
Last Updated: April 18, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014