Total Contact Soft Cast in Diabetic Foot Ulcers

University of Minnesota (UMN)

Status: Enrolling

Conditions: Ulcer, Leg; Foot Ulcer, Diabetic; Ulcer; Foot Ulcer; Diabetes Mellitus; Ankle Ulcer; Diabetic Foot Ulcer; Ulcer Foot

Treatments: Device: Total Contact Soft Cast; Device: Cam Boot

Study type: Interventional

Funder types: Other

Identifiers

NCT04210089

ORSU-2019-28102

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups

Soft Cast with a Removable Cam Boot

Experimental group

Description:

Patients with a foot, ankle, or lower leg ulcer (which we expect to be mostly diabetic foot ulcers) will be provided with a total contact soft cast with removable cam boot.

Treatment:

Device: Cam Boot

Device: Total Contact Soft Cast

Soft Cast without a Removable Cam Boot

Experimental group

Description:

Patients with a foot, ankle, or lower leg ulcer (which we expect to be mostly diabetic foot ulcers) will be provided with a total contact soft cast.

Treatment:

Device: Total Contact Soft Cast

Conventional

No Intervention group

Description:

Patients with a foot, ankle, or lower leg ulcer (which we expect to be mostly diabetic foot ulcers) will use conventional offloading including total contact casting, removable cast boots (cam boots), CROW boots, bracing, AFO's, offloading shoes, insoles, padding, shoe modifications, crutches, wheelchairs, rollabout, and surgical correction.