NCT00947726

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2010

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

July 27, 2009

Last Update Submit

February 18, 2026

Conditions

Foot Transepidermal Water Loss in Patients in NIDDMFoot Dryness in Patients With NIDDM

Outcome Measures

Primary Outcomes (1)

  • Decrease transepidermal water loss and foot dryness in study subjects.

    Baseline and 5 weeks

Study Arms (1)

CeraVe

EXPERIMENTAL

Ceramide based foot cream twice daily for two weeks

Other: CeraVe

Interventions

CeraVeOTHER

Using over the counter (OTC) cream on foot twice daily for two weeks.

Also known as: Ceramide based foot cream
CeraVe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 28, 2009

Study Start

July 1, 2009

Primary Completion

July 31, 2010

Study Completion

July 31, 2010

Last Updated

February 20, 2026

Record last verified: 2026-02