Total Contact Soft Cast in Diabetic Foot Ulcers

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Foot Ulcer; Ulcer; Diabetic Foot Ulcer; Foot Ulcer, Diabetic; Ulcer Foot; Ulcer, Leg; Ankle Ulcer
• Intervention / Treatment: Device: Total Contact Soft Cast; Device: Cam Boot

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph Schuster; Phone Number: 612-273-9400; Email: schus122@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • Recruiting
      • University of Minnesota
      • Contact: Joseph Schuster, DPM; Phone Number: 612-273-9400; Email: schus122@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soft Cast with a Removable 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.	Device: Total 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; Device: Cam 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.
Experimental: Soft Cast without a Removable 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.	Device: Total 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
No Intervention: Conventional; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Joseph Schuster, DPM, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Diabetic Neuropathies; Foot Diseases; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Ulcer; Leg Ulcer; Diabetes Mellitus; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: ORSU-2019-28102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No