Total Contact Soft Cast in Diabetic Foot Ulcers

Last updated: November 18, 2024
Sponsor: University of Minnesota
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Venous Leg Ulcers

Diabetes And Hypertension

Treatment

Total Contact Soft Cast

Cam Boot

Clinical Study ID

NCT04210089
ORSU-2019-28102
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any adult with a diabetic foot ulcer

Exclusion

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 Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Total Contact Soft Cast
Phase:
Study Start date:
October 13, 2020
Estimated Completion Date:
October 01, 2026

Study 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.

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55454
    United States

    Active - Recruiting

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