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Total Contact Soft Cast in Diabetic Foot Ulcers

Primary Purpose

Diabetic Foot Ulcer, Diabetes Mellitus, Foot Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Contact Soft Cast
Cam Boot
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Soft Cast with a Removable Cam Boot

Soft Cast without a Removable Cam Boot

Conventional

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Patient Complications
The percentage of patients who need to stop using the soft case due to complications will be calculated.

Full Information

First Posted
December 20, 2019
Last Updated
June 5, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04210089
Brief Title
Total Contact Soft Cast in Diabetic Foot Ulcers
Official Title
Total Contact Soft Cast in Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Diabetes Mellitus, Foot Ulcer, Foot Ulcer, Diabetic, Ulcer, Ulcer Foot, Ulcer, Leg, Ankle Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Soft Cast with a Removable Cam Boot
Arm Type
Experimental
Arm 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.
Arm Title
Soft Cast without a Removable Cam Boot
Arm Type
Experimental
Arm 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.
Arm Title
Conventional
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Total Contact Soft Cast
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Cam Boot
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete Healing Rates
Description
Complete healing is defined as complete epithelization of the ulcer. Outcome will be reported in days.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Patient Compliance with Use of the Total Contact Soft Cast
Description
The percentage of patients who use the total contact soft cast until complete healing or 16 weeks of treatment will be calculated.
Time Frame
16 weeks
Title
Patient Complications
Description
The percentage of patients who need to stop using the soft case due to complications will be calculated.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Schuster
Phone
612-273-9400
Email
schus122@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Schuster, DPM
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Schuster, DPM
Phone
612-273-9400
Email
schus122@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Total Contact Soft Cast in Diabetic Foot Ulcers

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