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

Inclusion Criteria4

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

Exclusion Criteria3

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

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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.