RecruitingNot ApplicableNCT04210089

Total Contact Soft Cast in Diabetic Foot Ulcers

Sponsor

University of Minnesota

Enrollment

100 participants

Start Date

Oct 13, 2020

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Diabetic Foot Ulcer Foot Ulcer, Diabetic Foot Ulcer Ulcer Ulcer Foot Ulcer, Leg Ankle Ulcer

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria1

\- Any adult with a diabetic foot ulcer

Exclusion Criteria6

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

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Interventions

DEVICETotal Contact Soft Cast

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

DEVICECam Boot

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.