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NCT04210089NARecruiting

Total Contact Soft Cast in Diabetic Foot Ulcers

University of Minnesota

Start Date

10/13/2020

Completion Date

10/1/2026

Summary

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

Detailed 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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Total Contact Soft Cast

DEVICE

Cam Boot

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Conditions

Diabetic Foot UlcerDiabetes MellitusFoot UlcerFoot Ulcer, DiabeticUlcerUlcer FootUlcer, LegAnkle Ulcer

Locations

University of Minnesota

Minneapolis, Minnesota 55454

United States