NCT05579743

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this research is to determine if a smartphone mobile application, also referred to as a mobile app or simply an app, designed to capture wound measurements and analyze wound tissue distribution in real-time, can be a practical patient-centered solution for regular wound management and assessment. The app will be compared to traditional in-person wound monitoring. One of the major limitations of most literature describing remote monitoring technologies is the lack of a control group. By randomizing half of the enrolled patients to remote monitoring via standard of care, the investigators will be able to compare patient and provider satisfaction with remote vs. in-person monitoring, as well as the wound healing outcomes.

Conditions

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

Interventions

Type	Name	Description
OTHER	Remote 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.

Timeline

• Start date: 2023-01-06
• Primary completion: 2026-01-01
• Completion: 2026-03-30
• First posted: 2022-10-14
• Last updated: 2025-01-24

Locations

1 site across 1 country: United States