|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
22 April 2013 |
|
Main ID: |
NCT01269502 |
|
Date of registration:
|
03/01/2011 |
|
Primary sponsor: |
|
|
Public title:
|
Prevention of Secondary Foot Ulcers in Patients With Diabetes Using Systematic Measuring of Skin Temperature.
|
|
Scientific title:
|
Prevention of Secondary Foot Ulcers in Patients With Diabetes. Will People With Diabetes Who Have Had a Foot Ulcer be Able to Prevent Secondary Ulcers by Systematically Measuring Their Skin Temperature? |
|
Date of first enrolment:
|
June 2009 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01269502 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
Norway
| | | | | | | |
|
Contacts
|
|
Name:
|
Bente K Kilhovd, Md, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Oslo University Hospital Ulleval, Oslo, Norway |
|
|
Name:
|
Anita Skafjeld |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Oslo University Hospital, Ulleval, Oslo, Norway |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Previous neuropathic diabetic foot ulcer
Exclusion Criteria:
- Ankle/brachial index < 0.7. Osteomyelitis, active Charcot
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Foot Ulcer, Diabetic
|
|
Intervention(s)
|
|
Device: "Temp Touch" Diabetica Solutions inc.
|
|
Other: Inspection
|
|
Primary Outcome(s)
|
|
Recurrency of diabetic foot ulcer
[Time Frame: One year]
|
|
Secondary ID(s)
|
|
20
|
|
6.2009.60
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|