Total Contact Soft Cast in Diabetic Foot Ulcers

Diabetes Mellitus Clinical Trial

Official title:

Total Contact Soft Cast in Diabetic Foot Ulcers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04210089
• Other study ID #: ORSU-2019-28102
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2020
• Est. completion date: October 1, 2024

Study information

• Verified date: June 2024
• Source: University of Minnesota
• Contact: Joseph Schuster
• Phone: 612-273-9400
• Email: schus122[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Healing Rates	Complete healing is defined as complete epithelization of the ulcer. Outcome will be reported in days.	16 weeks
Secondary	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
Secondary	Patient Complications	The percentage of patients who need to stop using the soft case due to complications will be calculated.	16 weeks