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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new software, called Ulcer Measurement Software, to measure diabetic foot ulcers using photos taken with a smartphone and a thermal camera. The goal is to evaluate how well the software assesses the size of these ulcers, aiding in their management and treatment. The trial includes two groups: diabetic patients with foot ulcers and healthy volunteers without ulcers. Individuals with Type 1 or Type 2 diabetes and a foot ulcer, receiving care at specific clinics in Iowa, may qualify for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance ulcer care for many.

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 prior data suggests that this ulcer measurement software is safe?

Research shows that the Ulcer Measurement Software safely measures and analyzes diabetic foot ulcers using digital images. Early results suggest it is easy to use, requiring only photos taken with a smartphone and a thermal camera. This non-invasive technology, which does not enter the body, has proven safe in other studies. For instance, research on similar digital wound measurement systems has confirmed their safety and ease of use. These systems accurately measure skin wounds, which is important for monitoring healing. Since this trial does not test a new drug or involve any invasive procedure, the risks remain very low. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a novel approach to managing diabetic foot ulcers using Ulcer Measurement Software. Unlike traditional methods that rely on manual measurement and visual assessment, this software provides precise digital tracking of ulcer size and progression. This technology could lead to more accurate assessments and personalized treatment plans, potentially improving patient outcomes and reducing healing times. By leveraging digital imaging, the software aims to offer a more objective and efficient way to monitor ulcer healing, which could revolutionize the standard care practices for diabetic foot ulcers.

What evidence suggests that this ulcer measurement software is effective for diabetic foot ulcers?

Research has shown that tools like the Ulcer Measurement Software, which participants in this trial may use, surpass older methods for checking diabetic foot ulcers. These tools automatically measure and assess the size and condition of ulcers, ensuring reliability and accuracy. One study highlighted that digital tools, such as the Ulcer Measurement Software, effectively track and manage wounds. They are easy to use and provide quick results, aiding medical settings. This technology aims to enhance the monitoring of diabetic foot ulcers, potentially leading to better healing outcomes. ^{3 4 6 7 8}

Who Is on the Research Team?

Linnea Polgreen, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7948910/

Wound assessment, imaging and monitoring systems in ... Most imaging systems are superior to traditional wound assessment. Wound imaging systems should be used as adjuncts in DFU monitoring.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06939686

Miro3D Wound Matrix Study for Diabetic Foot Ulcers and ... This study is designed to evaluate whether the addition of Miro3D to SOC accelerates healing and improves outcomes in Wagner Grade 1 DFUs, a common clinical ...

3. withpower.com withpower.com/trial/phase-ulcer-8-2017-3dc4e

Ulcer Measurement Software for Diabetic Foot Ulcer The Ulcer Measurement Software is unique because it uses digital imaging to automatically measure and analyze the size and quality of diabetic foot ulcers, ...

4. woundmatrix.com woundmatrix.com/

WoundMatrix WoundMatrix is a complete Mobile Wound Management/Telehealth solution for the secure capture, measurement and upload of images and data elements at the patient ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878124124000157

Application of a Diabetic Foot Smart APP in the ... The Diabetic Foot Smart APP is a fast and reliable measurement tool with high measurement accuracy that can be easily used in clinical practice.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06939686?draw=2&rank=1

Miro3D Wound Matrix Study for Diabetic Foot Ulcers and ... This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7580588/

Evaluation of a Novel Three-Dimensional Wound ... This system is capable of recreating a reliable 3D model of diabetic foot wounds, providing wound measurements. It has the potential to be a valuable adjunct in ...

8. mdpi.com mdpi.com/2079-9292/13/12/2390

Evaluation of Two Digital Wound Area Measurement ... The study validated the performance, safety, and usability of the implemented methods as a valuable tool in the measurement of skin lesions.