ClinicalTrials.gg
Not yet recruitingNCT07619430Updated Jun 2, 2026

AI-Based Wound Monitoring: Automated Wound Progression Assessment Via Marker-Free Image Sequence

An observational study in Hard-to-heal Wounds, AI (Artificial Intelligence) and Wound Care, sponsored by National Taiwan University Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to develop a low-cost, marker-free intelligent wound assessment system that can analyze wound photos taken with a standard smartphone. By comparing wound images over time, the system will generate a quantifiable Wound Progression Index (WPI) to provide objective feedback on whether a wound is improving, stable, or worsening. The long-term goal is to support early detection of wound deterioration and improve wound care in both clinical and home settings.

Read the detailed description

Participants receiving routine wound care will undergo standardized wound photography during dressing changes. Longitudinal wound images will be analyzed to develop and validate a marker-free wound progression assessment method. No treatment assignment or modification of standard clinical care will occur.

02

Conditions studied

  • Hard-to-heal Wounds
  • AI (Artificial Intelligence)
  • Wound Care
  • Pressure Injuries

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Keywords

  • chronic wounds
  • wound assessment
  • medical AI
  • semantic segmentation
  • longitudinal image registration
  • marker-free
  • wound progression index
  • home-based care
  • telemedicine
  • clinical validation
03

In context

Pressure Ulcer

545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 138 across 110 observational studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with hard-to-heal wounds located on body sites that can be fully captured within a single standardized image.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (1) Presence of a hard-to-heal wound that has remained unhealed for more than one month. (2)The wound can be photographed according to the standardized imaging protocol. (3)The participant was aged 18 years or older and provided personally or via a legally authorized representative, with a signed informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Wounds whose margins could not be fully included within the imaging field.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients with hard-to-heal wounds

    patients with hard-to-heal wounds

    Other: Marker-free wound image registration technology

Interventions

  • OtherMarker-free wound image registration technology

    Marker-free longitudinal wound image registration and wound progression assessment using serial wound photographs.

06

What researchers measure

Primary outcomes

  1. Agreement between marker-free and marker-based wound progression indices

    To evaluate the agreement between the Marker-Free Wound Progression Index (WPI\_MF) and the gold-standard marker-based Wound Progression Index (WPI\_GS) derived from longitudinal wound photographs.

    Time frame: Up to 6 months

Secondary outcomes

  1. Minimum image overlap threshold for reliable analysis

    To determine the minimum overlap ratio required to achieve statistically acceptable agreement.

    Time frame: Up to 6 months

07

Study locations

1 site
08

References and documents

Publications

  • Liu TJ, Wang H, Christian M, Chang CW, Lai F, Tai HC. Automatic segmentation and measurement of pressure injuries using deep learning models and a LiDAR camera. Sci Rep. 2023 Jan 13;13(1):680. doi: 10.1038/s41598-022-26812-9. PubMed 36639395 ↗
  • Bowling FL, King L, Paterson JA, Hu J, Lipsky BA, Matthews DR, Boulton AJ. Remote assessment of diabetic foot ulcers using a novel wound imaging system. Wound Repair Regen. 2011 Jan-Feb;19(1):25-30. doi: 10.1111/j.1524-475X.2010.00645.x. Epub 2010 Dec 6. PubMed 21134035 ↗
  • Anisuzzaman DM, Wang C, Rostami B, Gopalakrishnan S, Niezgoda J, Yu Z. Image-Based Artificial Intelligence in Wound Assessment: A Systematic Review. Adv Wound Care (New Rochelle). 2022 Dec;11(12):687-709. doi: 10.1089/wound.2021.0091. Epub 2021 Dec 20. PubMed 34544270 ↗
  • Foltynski P. Ways to increase precision and accuracy of wound area measurement using smart devices: Advanced app Planimator. PLoS One. 2018 Mar 5;13(3):e0192485. doi: 10.1371/journal.pone.0192485. eCollection 2018. PubMed 29505569 ↗
  • Isensee F, Jaeger PF, Kohl SAA, Petersen J, Maier-Hein KH. nnU-Net: a self-configuring method for deep learning-based biomedical image segmentation. Nat Methods. 2021 Feb;18(2):203-211. doi: 10.1038/s41592-020-01008-z. Epub 2020 Dec 7. PubMed 33288961 ↗
  • Hallett CE, Austin L, Caress A, Luker KA. Wound care in the community setting: clinical decision making in context. J Adv Nurs. 2000 Apr;31(4):783-93. doi: 10.1046/j.1365-2648.2000.01348.x. PubMed 10759974 ↗
  • Chen L, Cheng L, Gao W, Chen D, Wang C, Ran X. Telemedicine in Chronic Wound Management: Systematic Review And Meta-Analysis. JMIR Mhealth Uhealth. 2020 Jun 25;8(6):e15574. doi: 10.2196/15574. PubMed 32584259 ↗
  • Bloemen MC, van Zuijlen PP, Middelkoop E. Reliability of subjective wound assessment. Burns. 2011 Jun;37(4):566-71. doi: 10.1016/j.burns.2011.02.004. Epub 2011 Mar 8. PubMed 21388743 ↗
  • Olsson M, Jarbrink K, Divakar U, Bajpai R, Upton Z, Schmidtchen A, Car J. The humanistic and economic burden of chronic wounds: A systematic review. Wound Repair Regen. 2019 Jan;27(1):114-125. doi: 10.1111/wrr.12683. Epub 2018 Dec 2. PubMed 30362646 ↗

Individual participant data

Plan to share: Yes — wound images

Supporting information: Study protocol

Time frame: starting 6 months after publication

Access criteria: Requests must include a structured research proposal specifying the objectives, analysis plan, and data required. All requests will be reviewed by the corresponding investigator and the study's principal research team to ensure scientific validity, ethical compliance, and protection of participant confidentiality. Additional approval from an institutional review board or ethics committee may be required depending on the nature of the proposed analysis.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Dec 2027, 18 months later.

Of 49 observational studies under Pressure Ulcer, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 141. This study's planned 18 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2026
First posted
Jun 2, 2026
StartEst.
Jun 8, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Jun 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07619430
Collaborators
Industrial Technology Research Institute, Taiwan
Responsible party
Sponsor
First posted
Jun 2, 2026
Start date
Jun 8, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jun 2, 2026

Study contacts

Hui-Hsiu Chang
Contact
huihsiu@gmail.com
886-972655406

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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