RECRUITING

Feasibility and Effectiveness of a Remote Monitoring Program for the 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

This research is being done to compare two different methods of wound monitoring for chronic wounds: remote wound monitoring using a smartphone app and in-person wound monitoring in a clinic setting. This will be a pilot non-blinded randomized controlled feasibility trial. The investigators will enroll 120 patients with an active diabetic foot ulcer (DFU) who present to the multidisciplinary diabetic foot clinic in Baltimore, Maryland. Patients will be computer randomized 1:1 to receive wound care monitoring using remote DFU monitoring technology or standard in-person monitoring for 12 weeks.

Official Title

Feasibility of Remote Wound Care: Implementing a Patient-Centered Remote Wound Monitoring Solution Using a Smartphone Application

Quick Facts

Study Start:2023-01-06
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05579743

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, aged ≥ 18 years old
  2. * In treatment for lower extremity wound related to diabetic foot ulcer
  3. * Able and willing to use a smartphone to assess the wound for the duration of the study
  4. * English language proficiency
  1. * Patients with less than 1 dressing change per week
  2. * Patients with wound size that cannot be covered with a single app scan (out of boundary conditions include wounds that wrap around patient's entire leg)
  3. * Patients with wounds in an inaccessible location who live without a caregiver to assist in taking wound scans

Contacts and Locations

Study Contact

Caitlin Hicks, MD
CONTACT
410-955-5165
chicks11@jhmi.edu
Sherry Leung
CONTACT
410-955-7518
sleung7@jhu.edu

Principal Investigator

Caitlin Hicks, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine

Study Locations (Sites)

Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Caitlin Hicks, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins School of Medicine

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 Date2023-01-06
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-01-06
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Foot
  • Diabetic Foot Ulcer
  • Wound; Foot
  • Wound Leg
  • Wound Heal
  • Diabetes Complications