Total Contact Soft Cast in Diabetic Foot Ulcers

Sponsor

University of Minnesota (Other)

Overall Status

Recruiting

CT.gov ID

NCT04210089

Collaborator

(none)

100

Enrollment

Location

Arms

29.6

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer Diabetes Mellitus Foot Ulcer Foot Ulcer, Diabetic Ulcer Ulcer Foot Ulcer, Leg Ankle Ulcer	Device: Total Contact Soft Cast Device: Cam Boot	N/A

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.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Total Contact Soft Cast in Diabetic Foot Ulcers

Actual Study Start Date :

Oct 13, 2020

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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.	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 Device: 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.
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.	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
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.

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.

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

Device: 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.

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.

Device: Total Contact Soft Cast

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.

Outcome Measures

Primary Outcome Measures

Complete Healing Rates [16 weeks]
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 [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 [16 weeks]
The percentage of patients who need to stop using the soft case due to complications will be calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55454

Sponsors and Collaborators

University of Minnesota

Investigators

Principal Investigator: Joseph Schuster, DPM, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT04210089

Other Study ID Numbers:

ORSU-2019-28102

First Posted:

Dec 24, 2019

Last Update Posted:

Mar 3, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2022