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

NCT05579743 | Completed Results

• 2 other identifiers: IRB00292929R03DK133557
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

The feasibility phase of the study was conducted to assess the feasibility of a novel, patient-centered, remote wound management system. The investigators will enroll 25 patients with an active diabetic foot ulcer (DFU) who present to the multidisciplinary diabetic foot clinic in Baltimore, Maryland. The RCT 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Part A Feasibility - Number of Participants With Wound Scan Completion

  Participants were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks.

  8 weeks

• Participants Who Successfully Complete Weekly Wound Scan

  Successful weekly scan rate out of 12 weeks defined as total number of participants who successfully complete a weekly wound scan

  12 weeks

Study Arms (3)

Standard care

NO INTERVENTION

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

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).

Other: Remote wound monitoring technology

Feasibility Arm

OTHER

Part A Feasibility Phase: Remote Wound Monitoring Technology -- Patients with an active DFU are asked to capture weekly wound scans over an 8-week study period.

Other: Remote wound monitoring technology

Interventions

Remote wound monitoring technology 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.

Feasibility Arm; Remote wound monitoring technology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 40857414 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Foot Injuries; Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Leg Injuries; Wounds and Injuries

Limitations and Caveats

Data collection for the standard-care comparison group did not include comprehensive longitudinal wound tracking. The remote monitoring app was available only in English, which limited participation among non-English speakers. Technical barriers affected some participants who required loaner devices to access the app; loaner phones were provided when needed. The study duration was insufficient to evaluate longer-term outcomes such as major limb amputation, and a formal cost-effectiveness analys

Results Point of Contact

• Title: Caitlin W. Hicks MD
• Organization: Johns Hopkins University

chicks11@jhmi.edu

410-955-5165

Study Officials

• Caitlin Hicks, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility Phase: Patients were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks. RCT: Patients will be computer randomized 1:1 to receive wound care monitoring using remote diabetic foot ulcer (DFU) monitoring technology or standard in-person monitoring for 12 weeks

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: July 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: June 30, 2024
• Last Updated: July 2, 2026
• Results First Posted: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)