RecruitingNot ApplicableNCT05579743

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

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

Sponsor

Johns Hopkins University

Enrollment

120 participants

Start Date

Jan 6, 2023

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a smartphone app for remotely monitoring diabetic foot ulcers at home can be just as effective as regular in-person wound care visits. Patients take photos of their wound with the app, and the care team reviews them remotely to track healing progress. You may be eligible if: - You are 18 or older - You are being treated for a diabetic foot ulcer on your lower leg or foot - You have a smartphone and are willing and able to use the wound-monitoring app - You can communicate in English You may NOT be eligible if: - You have your wound dressed less than once a week - Your wound is too large to be captured in a single scan by the app - Your wound is in a hard-to-reach place and you live alone without a caregiver Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERRemote wound monitoring technology

Healthy.io developed a professional-user wound management system that captures wound measurements and analyzes tissue distribution in real time through a smartphone application. Clinical oversight of the healing status of the wound via remote imaging and expert review allows for real time intervention when stagnation or worsening of a wound is detected. Patients with wounds on their legs will receive access to Healthy.io's mobile app and will be able to perform self-scans of their wound which will be automatically sent to the medical professionals, thus allowing them to assess the wound remotely.