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

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05579743

Collaborator

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

120

Enrollment

Location

Arms

18.7

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Diabetic Foot Ulcer Wound; Foot Wound Leg Wound Heal Diabetes Complications	Other: Remote wound monitoring technology	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 weeksPatients 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

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Feasibility of Remote Wound Care: Implementing a Patient-Centered Remote Wound Monitoring Solution Using a Smartphone Application

Actual Study Start Date :

Dec 8, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: 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).	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.

Arm

Intervention/Treatment

No Intervention: 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.

Experimental: 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).

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.

Outcome Measures

Primary Outcome Measures

Proportion of participants who successfully complete a weekly wound scan [12 weeks]
Overall weekly scan rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

Johns Hopkins University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator: Caitlin Hicks, MD, Johns Hopkins School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT05579743

Other Study ID Numbers:

IRB00292929
R03DK133557

First Posted:

Oct 14, 2022

Last Update Posted:

Dec 9, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetic Foot

Foot Ulcer

Diabetes Complications

Wounds and Injuries

Study Results

No Results Posted as of Dec 9, 2022