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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Remote wound monitoring technology for diabetic foot ulcers?

Research shows that remote monitoring using smartphone apps can improve wound care by enhancing communication between patients and providers, and by allowing timely identification and management of wound issues. This approach has been effective in managing postsurgical wounds and is anticipated to improve care for diabetic foot ulcers by empowering patients in self-care and providing timely monitoring of risk factors. ^{1 2 3 4 5}

Is remote monitoring technology for wound care safe for humans?

Research on remote monitoring technology, like smartphone apps for wound care, shows it is generally safe for humans. These technologies have been used successfully to monitor and manage wounds, improving communication between patients and healthcare providers without reported safety issues. ^{1 2 3 6 7}

How does the remote wound monitoring technology treatment for diabetic foot ulcers differ from other treatments?

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, allowing for timely intervention and reducing the need for frequent clinic visits. This approach empowers patients in self-care and provides continuous monitoring, which can help prevent complications and improve outcomes compared to traditional in-person treatments. ^{2 3 5 8 9}

Research Team

Caitlin Hicks, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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.

I am 18 years old or older.

Able and willing to use a smartphone to assess the wound for the duration of the study

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient and Provider Preferences for Monitoring Surgical Wounds Using an mHealth App: A Formative Qualitative Analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The Promise of Smartphone Applications in the Remote Monitoring of Postsurgical Wounds: A Literature Review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Remote Wound Care. [2021]

4. England pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

Harnessing Digital Health Technologies to Remotely Manage Diabetic Foot Syndrome: A Narrative Review. [2022]

6. United States 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. [2022]

7. Canada 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. [2022]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers. [2022]