Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05579743

Feasibility of Remote Wound Care Using a Smartphone App Comparing Remote Monitoring to In-Person Care for Diabetic Foot Ulcers

Led by Johns Hopkins University · Updated on 2025-01-24

120

Participants Needed

1

Research Sites

168 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two different wound monitoring methods for patients with active diabetic foot ulcers: remote monitoring using a smartphone app versus traditional in-person monitoring at a clinic. This pilot study is a non-blinded randomized controlled feasibility trial involving 120 patients receiving care at a multidisciplinary diabetic foot clinic in Baltimore, Maryland. The aim is to assess whether the smartphone app can offer a practical, patient-centered solution for regular wound assessment and management compared to standard care, while also measuring patient and provider satisfaction and wound healing outcomes. Participants will be randomly assigned to either use the Healthy.io mobile app for remote wound monitoring or continue with standard in-person wound care for 12 weeks. The app captures wound measurements and tissue analysis in real time, allowing patients to perform self-scans of their wounds which are automatically sent to medical professionals for review. This remote monitoring system enables timely clinical interventions if the wound shows signs of stagnation or worsening. Throughout the 12-week study, researchers will track the proportion of participants who successfully complete weekly wound scans. Participants will need to use the smartphone app regularly or attend clinic visits depending on their group. The study involves ongoing clinical oversight, wound assessments, and comparisons of healing progress. The goal is to determine the feasibility and effectiveness of the remote monitoring program in managing diabetic foot ulcers.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged 6 18 years old
  • Currently receiving treatment for a lower extremity wound related to diabetic foot ulcer
  • Able and willing to use a smartphone to assess the wound for the study duration
  • Proficient in English language
Not Eligible

You will not qualify if you...

  • Patients with fewer than 1 dressing change per week
  • Patients with wound size too large to be covered with a single app scan (such as wounds wrapping around the entire leg)
  • Patients with wounds in locations that are difficult to access who do not have a caregiver to assist with wound scans

AI-Screening

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Trial Site Locations

Total: 1 location

1

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

C

Caitlin Hicks, MD

S

Sherry Leung

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

AI-Powered Remote Monitoring for Lower Extremity Wound Management: A Randomized Controlled Trial Protocol.

Y H Andrew Wu, Alana C Keegan, Midori P Starks White...

https://pubmed.ncbi.nlm.nih.gov/40857414