Remote Monitoring for Diabetic Foot Ulcers

Overseen By Sherry Leung

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Large wounds, Inaccessible wounds, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for monitoring diabetic foot ulcers: using a smartphone app at home and visiting a clinic in person. Researchers aim to determine if remote monitoring can match the effectiveness of traditional methods. Participants will either use the app to send wound pictures to doctors or attend regular clinic check-ups. This trial suits individuals with a diabetic foot ulcer who are comfortable using a smartphone for wound care. As an unphased trial, it offers a unique opportunity for patients to contribute to innovative research that could improve future diabetic foot ulcer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that remote wound monitoring technology is safe for diabetic foot ulcers?

Research has shown that patients generally receive remote technology for monitoring diabetic foot ulcers well. Studies have found that using a smartphone app to track and manage these wounds is practical and safe. This approach does not appear to cause more side effects than traditional in-person check-ups. However, one study found that while ulcer healing was similar between remote and standard care, the telehealth group had a higher death rate. This suggests that remote monitoring is generally safe, but patients should maintain close contact with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about remote wound monitoring technology for diabetic foot ulcers because it introduces a new way to track and manage wounds using a smartphone app. Unlike traditional care that requires frequent in-clinic visits, this technology allows patients to self-assess their wounds at home during regular dressing changes and send updates to doctors remotely. This could lead to more timely interventions, potentially improving healing rates and convenience for patients who might struggle with frequent clinic visits.

What evidence suggests that remote wound monitoring technology is effective for diabetic foot ulcers?

Research has shown that using a smartphone app to monitor wounds remotely can effectively manage diabetic foot ulcers. In this trial, some participants will use remote wound monitoring technology, which previous findings have identified as a cost-effective way to track wound healing. The app employs artificial intelligence (AI) to analyze the wound's condition. Early results suggest that patients can independently check their wounds and send crucial information to doctors without in-person visits. This method aims to simplify monitoring, potentially leading to better care and faster healing for individuals with diabetic foot ulcers. ^{1 2 6 7 8}

Who Is on the Research Team?

Caitlin Hicks, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with diabetic foot ulcers who are receiving treatment, can use a smartphone, and speak English. It's not suitable for those without help to scan wounds in hard-to-reach areas, have infrequent dressing changes, or have wounds too large for a single app scan.

Inclusion Criteria

I am receiving treatment for a wound from a 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

I have wounds in hard-to-reach areas and no one to help me take pictures of them.

I change my wound dressing less than once a week.

Your wound is too big to be covered by a single picture, like a wound that wraps around your whole leg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either remote wound monitoring using a smartphone app or standard in-person monitoring for diabetic foot ulcers

12 weeks

Biweekly visits for standard care group; monthly visits for remote monitoring group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote wound monitoring technology

Trial Overview The study compares remote monitoring of diabetic foot ulcers using a smartphone app versus traditional in-person clinic visits. Participants will be randomly assigned to one of the two methods and monitored over 12 weeks to assess feasibility and effectiveness.

How Is the Trial Designed?

Group I: Remote wound monitoring technology Experimental Treatment 1 Intervention

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 II: Standard care Active Control 1 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 is already approved in United States for the following indications:

Approved in United States as Remote wound monitoring technology for:

• Diabetic foot ulcers
• Chronic wound management

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Telemedicine and smartphone technology have significantly improved remote wound management, allowing registered nurses to effectively monitor and manage surgical infections at home, leading to better patient outcomes and reduced transportation costs.

Two randomized clinical trials highlighted in the review demonstrate that telehealth can enhance patient knowledge and outcomes in diabetic foot care, and that patients receiving home care guided by remote experts have better clinical and economic outcomes compared to those without expert guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Wound Care. Bolton, L.[2021]

In a study of 132 participants with diabetes and a history of foot ulcers, a remote foot-temperature monitoring system accurately predicted 97% of impending diabetic foot ulcers (DFUs) at a temperature asymmetry threshold of 2.22°C, providing an average lead time of 37 days.

The system was widely used, with 86% of participants using it at least 3 days a week, suggesting that it could significantly reduce the risk of DFUs and associated complications in patients with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers. Frykberg, RG., Gordon, IL., Reyzelman, AM., et al.[2022]

Remote monitoring of postsurgical wounds using smartphone apps can significantly improve healthcare quality and accessibility, as highlighted by a review of 83 relevant articles.

Despite the potential benefits, challenges such as patients' varying levels of technological competence and concerns about the reliability of data interpretation need to be addressed for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Promise of Smartphone Applications in the Remote Monitoring of Postsurgical Wounds: A Literature Review. Wang, SC., Au, Y., Ramirez-GarciaLuna, JL., et al.[2021]

The SmartBoot, a smart offloading device for diabetic foot ulcers, demonstrated high accuracy in monitoring patient adherence with an average accuracy of 89.3%, which is crucial for effective healing.

Participants showed improved balance while using the SmartBoot, suggesting that it provides beneficial somatosensory feedback, and most users found it comfortable and easy to use, indicating its potential for clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smart Offloading Boot System for Remote Patient Monitoring: Toward Adherence Reinforcement and Proper Physical Activity Prescription for Diabetic Foot Ulcer Patients. Park, C., Mishra, R., Vigano, D., et al.[2023]

A pilot study involving 39 nursing home residents demonstrated that a telehealth system for wound management improved patient outcomes compared to standard care, suggesting enhanced healing and better dressing product selection.

Nursing home staff reported that, despite initial concerns about the technology, the telehealth system was valuable and they were interested in integrating it into routine care, indicating its potential for broader application in wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study on the potential of remote support to enhance wound care for nursing-home patients. Vowden, K., Vowden, P.[2016]

Patients and providers expressed a strong interest in using a smartphone app for remote wound monitoring, indicating it could enhance communication about surgical site infections (SSIs).

The study identified that both groups are open to collaborating with telehealth services, suggesting a readiness to adopt technology for better management of surgical wounds and early identification of potential infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Provider Preferences for Monitoring Surgical Wounds Using an mHealth App: A Formative Qualitative Analysis. Sreedharan, S., Nemeth, LS., Hirsch, J., et al.[2023]

In a study of 160 patients using smart socks for remote temperature monitoring, the average utilization was high, with patients wearing the socks for 22 to 25 days per month and a retention rate of 91.9% over 7 months.

The high compliance and utilization rates suggest that smart socks could be an effective tool for monitoring temperature and potentially preventing foot ulcers, warranting further research into their clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of a Smart Sock for the Remote Monitoring of Patients With Peripheral Neuropathy: Cross-sectional Study of a Real-world Registry. Scholten, HJ., Shih, CD., Ma, R., et al.[2022]

The Swift Patient Connect App was effectively used by a 57-year-old diabetic patient to monitor and manage his chronic foot wound, demonstrating its potential as a valuable tool for remote wound care during the COVID-19 pandemic.

The app facilitated secure sharing of wound images and communication with healthcare providers, leading to successful management of multiple wound episodes, highlighting its role in enhancing patient engagement and care continuity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 57-Year-Old Man with Type 1 Diabetes Mellitus and a Chronic Foot Ulcer Successfully Managed with a Remote Patient-Facing Wound Care Smartphone Application. Kong, LY., Ramirez-GarciaLuna, JL., Fraser, RDJ., et al.[2022]

Diabetes affects 422 million people globally, with many at risk for diabetic foot ulcers due to factors like peripheral neuropathy and poor blood flow, highlighting the need for better prevention strategies rather than just treatment of existing conditions.

The review emphasizes the potential of wearable and digital health technologies to monitor risk factors, empower patient self-care, and facilitate remote management of diabetic foot ulcers, which could significantly reduce hospital admissions and improve outcomes for at-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing Digital Health Technologies to Remotely Manage Diabetic Foot Syndrome: A Narrative Review. Najafi, B., Mishra, R.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10244728/

Implementation of a patient-centered remote wound ... Our results suggest the feasibility of patient-facing technology for the remote wound app monitoring of diabetic foot ulcers. This study is the impetus for a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05579743

Feasibility and Effectiveness of a Remote Monitoring ... 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- ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949912725000960

AI-Powered Remote Monitoring for Lower Extremity Wound ... A cost-effective telehealth model using a smartphone-integrated digital application that remotely analyzes wound status with machine-learning ...

4. reporter.nih.gov reporter.nih.gov/search/69Kl-vIiDUel9-g11F40_Q/project-details/10509442

hicks, caitlin whitney The study will provide actionable data about the feasibility of using remote diabetic foot ulcer monitoring technology in disadvantaged patients, possibly ...

5. phrmafoundation.org phrmafoundation.org/news-events/blog/a-smart-boot-and-digital-monitoring-platform-to-improve-wound-healing-for-diabetic-foot-ulcer/

A Smart Boot and Digital Monitoring Platform to Improve ... A Smart Boot and Digital Monitoring Platform to Improve Wound Healing for Diabetic Foot Ulcer. By: Emily Ortman, PhRMA Foundation Head of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9846412/

Remotely Delivered Monitoring and Management of ... Telehealth provided equivalent ulcer healing outcomes compared to standard care, though mortality was higher in the telehealth group of one RCT. Telehealth ...

7. mdpi.com mdpi.com/1424-8220/24/10/2979

Towards a Remote Patient Monitoring Platform for ... This study aimed to design a holistic visualization tool to determine and visualize possible multiple digital biomarkers associated with poor diabetic wound ...

8. withpower.com withpower.com/trial/phase-foot-ulcer-10-2022-5e9c3

Remote Monitoring for Diabetic Foot Ulcers Remote wound monitoring technology is unique because it uses smartphone apps and digital health tools to monitor and manage diabetic foot ulcers from a distance ...