Back to resultsWound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
Primary Purpose
Neuropathic Foot Ulceration in Individuals With Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
cast vs. shoe
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Foot Ulceration in Individuals With Diabetes focused on measuring neuropathic foot ulcerations - total contact cast - custom -made footwear - off-loading
Eligibility Criteria
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
Sites / Locations
- Onze Lieve Vrouwe Gasthuis
Outcomes
Primary Outcome Measures
wound surface area reduction
Secondary Outcome Measures
time to wound healing (days)
Full Information
NCT ID
NCT00304733
First Posted
March 16, 2006
Last Updated
March 16, 2006
Sponsor
Rehabilitation Centre Amsterdam
Collaborators
ConvaTec Inc., Ontwikkelingsfonds Orthopedisch maatschoeisel
1. Study Identification
Unique Protocol Identification Number
NCT00304733
Brief Title
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
Official Title
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
Study Type
Interventional
2. Study Status
Record Verification Date
August 2001
Overall Recruitment Status
Unknown status
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rehabilitation Centre Amsterdam
Collaborators
ConvaTec Inc., Ontwikkelingsfonds Orthopedisch maatschoeisel
4. Oversight
5. Study Description
Brief Summary
Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Foot Ulceration in Individuals With Diabetes
Keywords
neuropathic foot ulcerations - total contact cast - custom -made footwear - off-loading
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
43 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
cast vs. shoe
Primary Outcome Measure Information:
Title
wound surface area reduction
Secondary Outcome Measure Information:
Title
time to wound healing (days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
f. b. van de weg, m.d.
Organizational Affiliation
rehabiliation centre amsterdam
Official's Role
Study Chair
Facility Information:
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1090 hm
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
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