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

Johns Hopkins University

Status: Enrolling

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

Treatments: Other: Remote wound monitoring technology

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05579743

R03DK133557 (U.S. NIH Grant/Contract)

IRB00292929

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Standard care

No Intervention group

Description:

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.

Remote wound monitoring technology

Experimental group

Description:

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).

Treatment:

Other: Remote wound monitoring technology