An interventional study of Ulcer Measurement Software in Foot Ulcer and Foot Ulcer, Diabetic, sponsored by Linnea Polgreen. Recruiting at 1 site in United States. Open to participants aged 21 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Linnea Polgreen · Not applicable, Interventional, and Screening
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.
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).
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 500 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Linnea Polgreen is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Compared within Diabetic Foot, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Foot Ulcer. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Diabetic patients with foot ulcers being seen in clinic.
Device: Ulcer Measurement Software
Patients without foot ulcers being seen in the clinic.
Photos being taken of foot ulcers. Software estimation of foot ulcer being compared to actual measured size.
Foot Ulcer Size
Size of foot ulcers will be determined by measurement and estimated by software
Time frame: 45 minutes
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.
Time frame: 45 minutes
Plan to share: No
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