Total Contact Soft Cast in Diabetic Foot Ulcers

NCT04210089 | Recruiting FDA Device

• 1 other identifier: ORSU-2019-28102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Complete Healing Rates

  Complete healing is defined as complete epithelization of the ulcer. Outcome will be reported in days.

  16 weeks

Secondary Outcomes (2)

• Patient Compliance with Use of the Total Contact Soft Cast

  16 weeks

• Patient Complications

  16 weeks

Study Arms (3)

Soft Cast with a Removable Cam Boot

EXPERIMENTAL

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; Device: Cam Boot

Soft Cast without a Removable Cam Boot

EXPERIMENTAL

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

Conventional

NO INTERVENTION

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.

Interventions

Total Contact Soft Cast DEVICE

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

Soft Cast with a Removable Cam Boot; Soft Cast without a Removable Cam Boot

Cam Boot DEVICE

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.

Soft Cast with a Removable Cam Boot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Any adult with a diabetic foot ulcer

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Foot Ulcer; Ulcer; Leg Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Foot Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Schuster, DPM

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Schuster

CONTACT

612-273-9400; schus122@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 24, 2019
• Study Start: October 13, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)