Status:
UNKNOWN
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
Lead Sponsor:
Rehabilitation Centre Amsterdam
Collaborating Sponsors:
ConvaTec Inc.
Ontwikkelingsfonds Orthopedisch maatschoeisel
Conditions:
Neuropathic Foot Ulceration in Individuals With Diabetes
Eligibility:
All Genders
18-80 years
Phase:
NA
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 footwea...
Eligibility Criteria
Inclusion
- confirmed diabetes
- neuropathic ulcer grade 1/2 (wagner scale)
- confirmed sensory neuropathy
Exclusion
- osteomyelitis patients unable to walk
- life threatening co-morbidity ankle/brachial index , 0.4
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00304733
Start Date
August 1 2001
End Date
April 1 2005
Last Update
March 20 2006
Active Locations (1)
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1
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, Netherlands, 1090 hm