Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

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

Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers

Condition
Diabetic Foot
Intervention / Treatment

-

Contacts and Locations

Baltimore

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female, aged ≥ 18 years old
  • * In treatment for lower extremity wound related to diabetic foot ulcer
  • * Able and willing to use a smartphone to assess the wound for the duration of the study
  • * English language proficiency
  • * Patients with less than 1 dressing change per week
  • * 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)
  • * Patients with wounds in an inaccessible location who live without a caregiver to assist in taking wound scans

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

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

Study Record Dates

2025-06-30