Total Contact Soft Cast in Diabetic Foot Ulcers
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joseph Schuster
- Phone Number: 612-273-9400
- Email: schus122@umn.edu
Study Locations
-
-
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
Accepts Healthy Volunteers
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
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.
|
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:
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.
|
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:
|
|
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
Time Frame: 16 weeks
|
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
Time Frame: 16 weeks
|
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
Time Frame: 16 weeks
|
The percentage of patients who need to stop using the soft case due to complications will be calculated.
|
16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph Schuster, DPM, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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