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Clinical Trial Summary

To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.


Clinical Trial Description

This study will evaluate whether the use of a total contact soft cast with or without a removable cam boot is as effective in healing diabetic foot ulcers as more commonly used offloading methods. The total contact soft cast will consist of wound dressing of choice to the ulcer and a plantar foot accommodative offloading felt pad for all foot ulcers, with 4x4 gauze pads added to the arch to create a rocker bottom for metarsophalangeal joint (MPJj) and plantar heel ulcers. The next layers will be: - Unna boot from MPJs to just below the knee, - Sterile Kerlix from MPJs to just below the knee - Sterile 4 inch Kling wrap from the MPJs to just below the knee, - Four inch coban from MPJs to just below the knee, and - Ace wraps from MPJs to just below the knee Removable diabetic cam boot will be used in patients willing and capable of using it. If patient does not want to use diabetic cam boot then surgical shoe or regular shoe would be options. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04210089
Study type Interventional
Source University of Minnesota
Contact Joseph Schuster
Phone 612-273-9400
Email schus122@umn.edu
Status Recruiting
Phase N/A
Start date October 13, 2020
Completion date October 1, 2024

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