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Clinical Trial 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


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00304733
Study type Interventional
Source Rehabilitation Centre Amsterdam
Contact
Status Active, not recruiting
Phase N/A
Start date August 2001
Completion date April 2005