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Total Contact Soft Cast in Diabetic Foot Ulcers

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

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.

Eligibility

Inclusion Criteria:

  • Any adult with a diabetic foot ulcer

Exclusion Criteria:

  • Allergy to Calamine or Zinc oxide
  • Inability to have leg wrapped
  • Inability to be seen weekly or as needed
  • Unable or unwilling to consent
  • Prisoners
  • Persons lacking capacity to consent

Study details

Diabetic Foot Ulcer, Diabetes Mellitus, Foot Ulcer, Foot Ulcer, Diabetic

NCT04210089

University of Minnesota

23 June 2024

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