NCT05094037

Brief Summary

The United States Department of Veterans Affairs spends an estimated $1.5 billion a year on healthcare for patients with diabetes. The prevalence and complications of diabetes increase with age. Therefore, with the aging of the US and Veteran populations, there is an expectation of increased healthcare costs associated with treating diabetes and the associated complications of this disorder. One common complication is the diabetic foot ulcer. Diabetic foot ulcers are expensive to treat, can take a long time to heal and result in a decrease in patient quality of life. Patients remain susceptible to developing more foot ulcers over time. The goal of this project is to reduce the time it takes to heal a diabetic foot ulcer, increase the time between episodes of ulceration and improve the quality of life for diabetic foot ulcer patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
2.1 years until next milestone

Study Start

First participant enrolled

December 4, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

May 4, 2026

Status Verified

May 1, 2026

Enrollment Period

2.2 years

First QC Date

October 22, 2021

Last Update Submit

May 1, 2026

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (4)

  • Orthosis wear-time

    The total time that the orthosis has been worn between clinic visits.

    At each clinic visit through study completion, an average of 8 months

  • Foot ulcer size

    Size of the diabetic foot ulcer.

    At each clinic visit through study completion, an average of 8 months

  • Foot ulcer healing status

    Status of the diabetic foot ulcer.

    At each clinic visit through study completion, an average of 8 months

  • Number of foot ulcers

    The number of diabetic foot ulcers.

    At each clinic visit through study completion, an average of 8 months

Study Arms (2)

Treatment group

EXPERIMENTAL

Patients will be given additional counseling

Device: Removable cam walker bootOther: Counseling

Control group

ACTIVE COMPARATOR

Patients will be given standard of care.

Device: Removable cam walker boot

Interventions

Removable cam walker bootDEVICE

Standard of care device given to diabetic foot ulcer patients.

Control groupTreatment group
CounselingOTHER

Additional education, counseling and encouragement of use of the orthosis beyond the current standard of care.

Treatment group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran patients prescribed an orthotic walking boot for treatment of their diabetic foot ulcer will be eligible to participate in the study.

You may not qualify if:

  • Veteran patients with amputation proximal to the tarsometatarsal joint, with a Meggitt-Wagner score of 4 or more, with severe infection, with non-ambulatory status or without palpable pedal pulse will be excluded
  • All patients will be screened for severe cognitive impairment with the 15 point Brief Interview for Mental Status (BIMS)
  • scores between 12 and 8 will indicate need for extra efforts to support comprehension of instructions, and patients with scores of 7 or less will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Counseling

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Muturi G. Muriuki, PhD

    Edward Hines Jr. VA Hospital, Hines, IL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2021

First Posted

October 26, 2021

Study Start

December 4, 2023

Primary Completion

February 28, 2026

Study Completion

March 31, 2026

Last Updated

May 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)