University of Minnesota
Minneapolis, Minnesota, 55454, United States
Location status: Recruiting
Recruiting
NCT Number: NCT04210089
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Diabetic Foot Ulcer
Ankle Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Foot
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Foot Ulcer
Foot Ulcer, Diabetic
Glucose Metabolism Disorders
Leg Ulcer
Metabolic Diseases
Nutritional and Metabolic Diseases
Pathologic Processes
Pathological Conditions, Signs and Symptoms
Skin Diseases
Skin Ulcer
Skin and Connective Tissue Diseases
Ulcer
Ulcer Foot
Ulcer, Leg
Vascular Diseases
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Total Contact Soft Cast
DeviceThe 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
Cam Boot
DeviceRemovable 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 outcomes
-
Complete Healing Rates
Time frame: 16 weeks
Complete healing is defined as complete epithelization of the ulcer. Outcome will be reported in days.
Secondary outcomes
-
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.
-
Patient Complications
Time frame: 16 weeks
The percentage of patients who need to stop using the soft case due to complications will be calculated.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Minnesota
Other
Registry information
Important dates
- Study start
- 2020
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Dec 24, 2019
- Registry last updated
- Dec 15, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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