Ulcer Measurement Software for Diabetic Foot Ulcer

Overseen By Linnea Polgreen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Linnea Polgreen

Disqualifiers: Cognitive impairment, Lack of English fluency, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

500 Participants Needed

Trial Summary

What is the purpose of this trial?

All study procedures will occur during one appointment. The research team will measure the size of the foot ulcer (if one is present) and multiple photos will be taken with a smart phone camera and thermal camera. Demographic information will be obtained from the medical record.

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the treatment Ulcer Measurement Software for Diabetic Foot Ulcer?

Research shows that digital tools for assessing foot ulcers, like the Ulcer Measurement Software, can help healthcare providers better evaluate and track the healing of wounds. These tools can improve the accuracy of measuring wound size and tissue quality, which is important for effective treatment and reducing complications. ^{1 2 3 4 5}

Is the Ulcer Measurement Software safe for use in humans?

The studies reviewed focus on the effectiveness and precision of digital wound measurement tools like WoundMatrix and Mowa®, but they do not report any safety concerns or adverse effects, suggesting these tools are generally safe for use in humans. ^{1 4 5 6 7}

How is the Ulcer Measurement Software treatment different from other treatments for diabetic foot ulcers?

The Ulcer Measurement Software is unique because it uses digital imaging to automatically measure and analyze the size and quality of diabetic foot ulcers, providing a more objective and consistent assessment compared to traditional visual and manual methods. This software can be used on various devices, making it accessible and practical for both urban and nonurban healthcare settings. ^{1 4 5 8 9}

Research Team

Linnea Polgreen, PhD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for individuals with Type 1 or Type 2 Diabetes who currently have a foot ulcer. Participants must be receiving care at specific University of Iowa Hospitals and Clinics locations. It's not open to those who can't consent due to cognitive issues, don't speak English well, or dislike research studies.

Inclusion Criteria

You have been diagnosed with either Type 1 or Type 2 diabetes.

You currently have a wound on your foot.

You are currently getting medical care at specific clinics within the University of Iowa Hospitals and Clinics.

Exclusion Criteria

Cognitive impairment that prevents consent

Lack of fluency in speaking or understanding English

Known aversion to research studies

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Study Procedures

Participants undergo foot ulcer measurement and photography using various methods and cameras

45 minutes

1 visit (in-person)

Data Collection

Demographic information is collected from medical records

Same day

Treatment Details

Interventions

• Ulcer Measurement Software

Trial Overview The study tests an Ulcer Measurement Software by measuring the size of diabetic foot ulcers using photos from smartphones and thermal cameras during one appointment.

Participant Groups

Group I: Ulcer Measurement and Photo Group Experimental Treatment 1 Intervention

Diabetic patients with foot ulcers being seen in clinic.

Group II: Healthy Control Group Active Control 1 Intervention

Patients without foot ulcers being seen in the clinic.

Ulcer Measurement Software is already approved in United States, European Union for the following indications:

Approved in United States as WoundMatrix for:

• Diabetic Foot Ulcer Measurement
• Pressure Ulcer Measurement
• Wound Assessment

Approved in European Union as imitoMeasure for:

• Pressure Ulcer Measurement
• Wound Assessment
• General Wound Measurement

Who Is Running the Clinical Trial?

Linnea Polgreen

Lead Sponsor

Trials

4

Recruited

1,500+

Fraternal Order of the Eagles Diabetes Research Center

Collaborator

Trials

1

Recruited

500+

Findings from Research

A new wound assessment system using image capture and analysis was developed and tested on 12 patients with foot ulcers, showing promise in providing quantitative assessments of wound healing.

The system's algorithms demonstrated a Matthews correlation coefficient of .68 for wound area determination and a Krippendorff's alpha coefficient ranging from .42 to .81 for the healing score, indicating good reliability compared to experienced clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Automatic Assessment System of Diabetic Foot Ulcers Based on Wound Area Determination, Color Segmentation, and Healing Score Evaluation. Wang, L., Pedersen, PC., Strong, DM., et al.[2018]

The Image J-based Computer Analysis method for measuring diabetic foot ulcer areas showed high agreement with traditional methods, making it a reliable alternative for routine assessments.

In a study involving 65 ulcers, the Image J method demonstrated consistent results with other measurement techniques, highlighting its accuracy and accessibility for healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of area measurement methods in the routine assessment of diabetic foot ulcers-A consistency analysis method. Luo, YX., Li, L., Mai, LF., et al.[2023]

The TeleDiaFoS system and SilhouetteMobile device provided the best accuracy in measuring diabetic foot wound areas, while the Visitrak device was less effective for wounds smaller than 2 cm².

The Elliptical method significantly overestimates wound area by up to 33%, making it unsuitable for critical applications like predicting wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy and precision of selected wound area measurement methods in diabetic foot ulceration. Foltynski, P., Ladyzynski, P., Sabalinska, S., et al.[2013]

The Wound Healing Analyzing Tool (WHAT) demonstrated a high accuracy rate of 87% in assessing diabetic foot ulcers, aligning closely with evaluations made by a trained physician in a study involving 18 patients.

WHAT can be effectively used in clinical settings to measure wound area and condition, making it a valuable option for digital consultations, especially in areas lacking wound specialists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A digital assessment and documentation tool evaluated for daily podiatric wound practice. Jelinek, HF., Prinz, M., Wild, T.[2015]

The Mowa® application allows surgeons to quickly and accurately assess the surface area and tissue quality of skin ulcers using photographs, making it easier to monitor treatment progress over time.

This mobile app not only quantifies wound size but also analyzes tissue characteristics, such as fibrin percentage and exudate levels, and provides treatment algorithms based on established guidelines, enhancing the management of chronic skin injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MowA®: A simple and economic way of monitoring chronic wounds outcome with your mobile devices. Ciancio, F., Portincasa, A., Parisi, D., et al.[2018]

The WoundAide app demonstrated high reliability and validity in measuring wound dimensions, comparable to established methods like Wound Zoom and Visitrak, with an intraclass correlation coefficient greater than 0.95 for all measurements.

While WoundAide showed similar accuracy, it had lower sensitivity in capturing images (75% compared to 99.4% for Visitrak and 100% for Wound Zoom), indicating a need for further improvements to enhance its performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating an iPad app in measuring wound dimension: a pilot study. Khong, PCB., Yeo, MSW., Goh, CC.[2019]

Digital image measurements of wound areas using WoundMatrix Web showed high reproducibility and precision among caregivers at the Johns Hopkins Wound Center, indicating that this method is reliable for tracking wound progress.

The study supports the use of digital imaging for monitoring wounds and evaluating the effectiveness of new treatments in clinical trials, enhancing the ability to document healing over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital imaging of wounds: are measurements reproducible among observers? Quan, SY., Lazarus, GS., Kohli, AR., et al.[2007]

In a study involving 20 patients with chronic lower limb ulcers, standardized digital photography was found to be a quick and precise method for estimating ulcer areas, showing a strong correlation with traditional planimetric measurements (R²=0.86).

The correlation was even stronger when comparing digital photos of drawings of the ulcer perimeters to planimetric measures (R²=0.99), suggesting that using drawings for area estimation is preferable to direct photographic analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chronic ulcers of the lower limbs: area evaluation by digital photography]. Miot, HA., Mendaçolli, TJ., Costa, SV., et al.[2022]

A new web-based tool allows doctors and caregivers to upload images of ulcers from any device, making it easier to track and manage ulcer treatment.

The tool uses advanced image processing algorithms to automatically measure ulcer size, which can help in monitoring healing progress and improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cloud-Driven Application for Measurement of Wound Size. Kompalliy, S., Bakarajuy, V., Gogia, SB.[2019]

References

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

An Automatic Assessment System of Diabetic Foot Ulcers Based on Wound Area Determination, Color Segmentation, and Healing Score Evaluation. [2018]

2. Australia pubmed.ncbi.nlm.nih.gov

Comparison of area measurement methods in the routine assessment of diabetic foot ulcers-A consistency analysis method. [2023]

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

Accuracy and precision of selected wound area measurement methods in diabetic foot ulceration. [2013]

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

A digital assessment and documentation tool evaluated for daily podiatric wound practice. [2015]

5. Italy pubmed.ncbi.nlm.nih.gov

MowA®: A simple and economic way of monitoring chronic wounds outcome with your mobile devices. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Evaluating an iPad app in measuring wound dimension: a pilot study. [2019]

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

Digital imaging of wounds: are measurements reproducible among observers? [2007]

8. Brazil pubmed.ncbi.nlm.nih.gov

[Chronic ulcers of the lower limbs: area evaluation by digital photography]. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Cloud-Driven Application for Measurement of Wound Size. [2019]