Total Contact Soft Cast in Diabetic Foot Ulcers

Not Applicable

Recruiting

• Conditions: Ulcer; Diabetes Mellitus; Ulcer, Leg; Ulcer Foot; Diabetic Foot Ulcer; Foot Ulcer; Ankle Ulcer; Foot Ulcer, Diabetic
• Interventions: Device: Total Contact Soft Cast; Device: Cam Boot

• Registration Number: NCT04210089
• Lead Sponsor: University of Minnesota

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-24
• Study Start: 2020-10-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-19
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Any adult with a diabetic foot ulcer

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soft Cast with a Removable Cam Boot	Cam Boot	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.
Soft Cast with a Removable Cam Boot	Total Contact Soft Cast	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.
Soft Cast without a Removable Cam Boot	Total Contact Soft Cast	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.

Primary Outcome Measures

Name	Time	Method
Complete Healing Rates	16 weeks	Complete healing is defined as complete epithelization of the ulcer. Outcome will be reported in days.

Secondary Outcome Measures

Name	Time	Method
Patient Compliance with Use of the Total Contact Soft Cast	16 weeks	The percentage of patients who use the total contact soft cast until complete healing or 16 weeks of treatment will be calculated.
Patient Complications	16 weeks	The percentage of patients who need to stop using the soft case due to complications will be calculated.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States