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

NCT ID: NCT05579743

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-06
• Study Completion Date: 2026-03-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard care

Patients randomized to receive standard of care will be provided with a wound care plan at the time of enrollment, and then follow-up in clinic on a biweekly basis (week 2, 4, 6, 8, 10, 12) for a wound check and care plan update as needed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Remote wound monitoring technology

Enrolled patients (and their caregivers, if applicable) are given an in-person training on how to use the smartphone app to self-assess their wound during regular dressing changes. Wound assessments are electronically transmitted to a secure, dedicated portal up to once a week for remote review by the study doctors. In-person follow-up is monthly (at the time of enrollment, week 4, week 8, and week 12).

Group Type: EXPERIMENTAL

Remote wound monitoring technology

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caitlin Hicks, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Caitlin Hicks, MD

Role: CONTACT

chicks11@jhmi.edu

410-955-5165

Sherry Leung

Role: CONTACT

sleung7@jhu.edu

410-955-7518

Facility Contacts

Caitlin Hicks, MD

Role: primary

410-955-5165

References

Wu YHA, Keegan AC, White MPS, Bose S, Leung SG, Sherman R, Abularrage CJ, Selvin E, Hicks CW. AI-Powered Remote Monitoring for Lower Extremity Wound Management: A Randomized Controlled Trial Protocol. JVS Vasc Insights. 2025 Aug 8:100279. doi: 10.1016/j.jvsvi.2025.100279. Online ahead of print.

Reference Type: DERIVED

PMID: 40857414 (View on PubMed)

Other Identifiers

R03DK133557

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00292929

Identifier Type: -

Identifier Source: org_study_id