Foot UlcerNCT03942081
Diabetic Foot Ulcer Imaging- Study 2
A study testing Ulcer Measurement Software in people with Foot Ulcer and Foot Ulcer, Diabetic, run by Linnea Polgreen at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Foot Ulcer, Foot Ulcer, Diabetic
- What is being tested?
- Ulcer Measurement Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2017to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Type 1 or Type 2 Diabetes
- Has a current foot lesion
- Receiving care through University of Iowa Hospitals and Clinics (UIHC) Iowa River Landing Diabetes Clinic, UIHC Internal Medicine Clinic, or UIHC Orthopedic Clinic.
Who cannot join
- Cognitive impairment that prevents consent
- Lack of fluency in speaking or understanding English
- Known aversion to research studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Shelby L Francis, PhD, 319-775-0689, shelby-francis@uiowa.edu
About this study
Official title: Testing the Accuracy and Feasibility of Diabetic Foot Ulcer Imaging
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.
Read the detailed description
The research procedures consist of a) a research assistant measuring the size of the foot ulcer (for ulcer patients), b) patients having pictures of their feet taken with a smart phone under 4 conditions- 1) photos taken by researchers, 2) photos taken by the patient by hand, 3) photos taken by the patient with a selfie stick, and 4) photos taken by a 3rd party (e.g., friend/family member of patient). If the patient is not able to take photographs under any of the conditions, that condition will be excluded. In addition to photos being taken with a smart phone, additional photos will be taken with a thermal camera by the research team to determine if there is a difference in ulcer size depending on type of camera used. It is anticipated that procedures will last between 15 and 45 minutes. There is no long-term follow-up. If a patient returns to the clinic they will be asked if they wish to complete all study procedures again. Once the patient has left the clinic, the research team will check the medical record for: age, sex, race, ethnicity, BMI, co-morbidities, and zip code (to determine if patient lives in an urban or rural location).
- Conditions
- Foot Ulcer, Foot Ulcer, Diabetic
- Being tested
- Ulcer Measurement Software
- Medical subject headings
- Foot Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulcer Measurement SoftwareDevice
Photos being taken of foot ulcers. Software estimation of foot ulcer being compared to actual measured size.
| Study group | Role | What they receive |
|---|---|---|
| Ulcer Measurement and Photo Group | Experimental | Diabetic patients with foot ulcers being seen in clinic. Receives: Device: Ulcer Measurement Software |
| Healthy Control Group | No intervention | Patients without foot ulcers being seen in the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Ulcer Size
Size of foot ulcers will be determined by measurement and estimated by software
Measured: 45 minutes
Secondary outcomes (1)
Quality of Photos: 1 - 5 scale
Quality of foot ulcer photos will be quantitatively assessed using a 1 - 5 scale (with 1 being poor focus and lighting and 5 being excellent focus and lighting). These scores will be determined subjectively by multiple researchers and averaged to a single score.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start5 Sep 2017
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linnea Polgreen
- Sponsor type
- University, hospital or other
- Collaborators
- Fraternal Order of the Eagles Diabetes Research Center
- Responsible party
- Sponsor-investigator, Linnea Polgreen, University of Iowa
- Investigators
- Linnea Polgreen, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942081
- Sponsor's protocol ID
- 201706725
- Status last verified
- Sep 2026
- First submitted
- 6 May 2019
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Accuracy and Feasibility of Diabetic Foot Ulcer Imaging
- ClinicalTrials.gov ID
- NCT03942081
- Acronym / sponsor ID
- 201706725
- Conditions
- Foot Ulcer, Foot Ulcer, Diabetic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Linnea PolgreenUniversity, hospital or other
- Collaborators
- Fraternal Order of the Eagles Diabetes Research Center
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research procedures consist of a) a research assistant measuring the size of the foot ulcer (for ulcer patients), b) patients having pictures of their feet taken with a smart phone under 4 conditions- 1) photos taken by researchers, 2) photos taken by the patient by hand, 3) photos taken by the patient with a selfie stick, and 4) photos taken by a 3rd party (e.g., friend/family member of patient). If the patient is not able to take photographs under any of the conditions, that condition will be excluded. In addition to photos being taken with a smart phone, additional photos will be taken with a thermal camera by the research team to determine if there is a difference in ulcer size depending on type of camera used. It is anticipated that procedures will last between 15 and 45 minutes. There is no long-term follow-up. If a patient returns to the clinic they will be asked if they wish to complete all study procedures again. Once the patient has left the clinic, the research team will check the medical record for: age, sex, race, ethnicity, BMI, co-morbidities, and zip code (to determine if patient lives in an urban or rural location).
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcer Measurement and Photo Group | Experimental | Device: Ulcer Measurement SoftwareDiabetic patients with foot ulcers being seen in clinic. |
| Healthy Control Group | No intervention | –Patients without foot ulcers being seen in the clinic. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with Type 1 or Type 2 Diabetes
- Has a current foot lesion
- Receiving care through University of Iowa Hospitals and Clinics (UIHC) Iowa River Landing Diabetes Clinic, UIHC Internal Medicine Clinic, or UIHC Orthopedic Clinic.
Key exclusion criteria (3 listed)
- Cognitive impairment that prevents consent
- Lack of fluency in speaking or understanding English
- Known aversion to research studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulcer Measurement SoftwarePhotos being taken of foot ulcers. Software estimation of foot ulcer being compared to actual measured size. | Device | Ulcer Measurement and Photo Group |
Primary outcome
Foot Ulcer Size
Time frame: 45 minutes
Size of foot ulcers will be determined by measurement and estimated by software
1 secondary outcome
Quality of Photos: 1 - 5 scale
Time frame: 45 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linnea Polgreen, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulcer Measurement Software in people with Foot Ulcer and Foot Ulcer, Diabetic, run by Linnea Polgreen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linnea Polgreen, PhD ((319) 384-3024, linnea-polgreen@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Ulcer Size (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.