- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00304733
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
March 16, 2006 updated by: Rehabilitation Centre Amsterdam
Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
In this prospective clinical trail, 43 patients with plantar ulcer grade 1 or 2 (wagner scale) were randomized to one of two off-loading modalities: total contact cast or custom-made temporary footwear.outcomes
assessed were wound surface area reduction (square cm.)and time to wound healing (days0 at 2,4,8 and 16 weeks.
to evaluate safety, possible side effects were recorded at each follow-up visit.
Study Type
Interventional
Enrollment
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Noord Holland
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Amsterdam, Noord Holland, Netherlands, 1090 hm
- Onze Lieve Vrouwe Gasthuis
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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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- confirmed diabetes
- neuropathic ulcer grade 1/2 (wagner scale)
- confirmed sensory neuropathy
Exclusion Criteria:
- osteomyelitis patients unable to walk
- life threatening co-morbidity ankle/brachial index , 0.4
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: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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wound surface area reduction
|
Secondary Outcome Measures
Outcome Measure |
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time to wound healing (days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: f. b. van de weg, m.d., rehabiliation centre amsterdam
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
August 1, 2001
Study Completion
April 1, 2005
Study Registration Dates
First Submitted
March 16, 2006
First Submitted That Met QC Criteria
March 16, 2006
First Posted (Estimate)
March 20, 2006
Study Record Updates
Last Update Posted (Estimate)
March 20, 2006
Last Update Submitted That Met QC Criteria
March 16, 2006
Last Verified
August 1, 2001
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024
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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