RECRUITING

Orthotic Treatment of Diabetic Foot Ulcers

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Orthotic Treatment of Diabetic Foot Ulcers: Patient Adherence to Prescribed Wear and Effectiveness of Treatment

Quick Facts

Study Start:2023-12-04
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05094037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veteran patients prescribed an orthotic walking boot for treatment of their diabetic foot ulcer will be eligible to participate in the study.
  1. * 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
  2. * All patients will be screened for severe cognitive impairment with the 15 point Brief Interview for Mental Status (BIMS)
  3. * 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

Contacts and Locations

Study Contact

Muturi G Muriuki, PhD
CONTACT
(708) 202-5788
Muturi.Muriuki@va.gov
Robert Havey, MS
CONTACT
(708) 202-3781
Robert.Havey@va.gov

Principal Investigator

Muturi G. Muriuki, PhD
PRINCIPAL_INVESTIGATOR
Edward Hines Jr. VA Hospital, Hines, IL

Study Locations (Sites)

Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Muturi G. Muriuki, PhD, PRINCIPAL_INVESTIGATOR, Edward Hines Jr. VA Hospital, Hines, IL

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-04
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-12-04
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Foot Ulcer