AzTrials
AzTrials

LymphedemaCDTLNCT07485465

Lymphoedema Diagnosis and Treatment

An observational study of Lymphedema and Artificial Intelligence (AI), run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

A domain-specific, custom-trained large language model for the differential diagnosis and treatment planning of lymphedema, lipedema, and venous insufficiency. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphedema, Artificial Intelligence (AI)
What is being tested?
a domain-specific, custom-trained large language model for the differential diagnosis and treatment planning of lymphedema, lipedema, and venous insufficiency
How many people
25 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Mar 2026to 1 Apr 2026
How long will I take part?
1 Day
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: secondary lymphedema cases (post-pelvic surgery, post-breast cancer), primary lymphedema cases, lipedema cases (different types and stages), chronic venous insufficiency cases, mixed edema cases, and atypical presentations with diagnostic difficulties

Who may be able to join

  • Patients over the age of 18
  • Clinical diagnosis of lymphoedema
  • Clinical diagnosis of lipoedema
  • Clinical diagnosis of venous insufficiency

Who cannot join

  • Lack of medical history
  • Lack of demographic data
  • Lack of clinical data and
  • Lack of imaging methods

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yunus Emre Doğan, MD contact

+90 506 051 25 00

ynsemredgn91@gmail.com

Turkey (Türkiye)1 site
  • Istanbul Fatih Sultan Mehmet Training and Research Hospital

    Istanbul, Istanbul, 34704

    İlknur Aktaş, MD, Prof., +90 533 714 63 52, iaktas@hotmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: The Role of Chat GPT in the Diagnosis and Treatment of Lymphedema

A domain-specific, custom-trained large language model for the differential diagnosis and treatment planning of lymphedema, lipedema, and venous insufficiency.

Read the detailed description

The differential diagnosis of lower limb swelling remains problematic in clinical practice, as lymphedema, lipedema, and peripheral venous disease often present with similar features. Therefore, we developed LymphedemaGPT, a GPT-5-based clinical assistant designed to help practitioners navigate these diagnostic complexities.

LymphedemaGPT was designed to analyze structured patient data to extract clinical summaries, present possible diagnoses with percentage probabilities, create differential diagnosis tables, suggest additional diagnostic tests, and generate evidence-based treatment plans.

LymphedemaGPT's responses are based on seven scientific publications uploaded to the system, in addition to the Sleigh BC \& Manna B (2023) and Rockson approaches. Owing to this resource integration, the model can provide more reliable and consistent recommendations aligned with evidence-based medicine principles based on current guidelines and scientific publications.

Extensive prompt engineering techniques were applied to optimize the diagnostic and therapeutic accuracy of LymphedemaGPT.

The model is programmed to prioritize the questioning phase until a diagnosis is confirmed. In the initial responses, only structured anamnesis questions were asked, and after sufficient information was collected, systematic analysis and treatment planning were initiated. The response flow was designed as follows: (1) history collection, (2) preliminary assessment, (3) additional questioning (if necessary), and (4) systematic analysis and treatment planning when sufficient data were obtained.

The following patient data was presented to LymphedemaGPT in a structured format:

Demographic data: Age, gender, height, weight Medical history: Additional illnesses, medications used, habits (smoking, alcohol) Complaint characteristics: Time of onset, affected area, symptoms (pain, heaviness, numbness, tingling, stiffness, limited movement, weakness, etc.) Physical examination findings: Stemmer sign, swelling change with elevation, skin findings Medical history: History of infection, history of surgery, history of malignancy (radiotherapy, chemotherapy, lymph node dissection, type of cancer) Imaging: Doppler ultrasonography and lymphoscintigraphy results, if available

LymphedemaGPT was asked to respond in the following 12-part standard format: (1) Clinical Summary, (2) Possible Diagnoses (% probability), (3) Differential Diagnosis, (4) Recommended Diagnostic Tests, (5) Treatment Plan, (6) Patient Education and Follow-up, (7) Red Flags, (8) references, (9) Level of Evidence and Confidence Score, (10) Ethical Note, (11) Data Summary (JSON/CSV), and (12) Analysis Timestamp.

The performance of LymphedemaGPT was evaluated by experienced physicians based on the following eight criteria:

  1. Accuracy and adequacy of clinical summary
  2. Accuracy of primary diagnosis
  3. Accuracy of differential diagnosis table
  4. Appropriateness of recommended diagnostic tests
  5. Concordance of treatment plan with current guidelines
  6. Appropriateness of compression class/exercise-diet recommendations
  7. Adequacy of red flags
  8. Overall clinical utility

Each criterion was scored using a 5-point Likert scale: 5 = excellent/completely suitable, 4 = good/significantly suitable, 3 = moderate/partially suitable, 2 = poor/inadequate, and 1 = very poor/not suitable. The maximum score for each case was 40 (8 criteria × 5 points), and the minimum score was 8.

Two experienced physicians independently performed the evaluation. The evaluators were physical medicine and rehabilitation specialists experienced in the management of lymphedema and lipedema, and they independently performed the scoring.

Being tested
a domain-specific, custom-trained large language model for the differential diagnosis and treatment planning of lymphedema, lipedema, and venous insufficiency
Keywords
lymphedema, chat gpt, artificial intelligence
Medical subject headings
Lymphedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • a domain-specific, custom-trained large language model for the differential diagnosis and treatment planning of lymphedema, lipedema, and venous insufficiencyOther

    LymphedemaGPT was designed to analyze structured patient data to extract clinical summaries, present possible diagnoses with percentage probabilities, create differential diagnosis tables, suggest additional diagnostic tests, and generate evidence-based treatment plans.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic accuracy rate

    Percentage of cases where the primary diagnosis (most likely diagnosis) was correctly determined. The maximum percentage for each case was 100, and the minimum percentage was 0. Higher percentages mean a better outcome.

    Measured: 1 hour

  2. Treatment adequacy rate

    Percentage of treatment recommendations consistent with current guidelines. The maximum percentage for each case was 100, and the minimum percentage was 0. Higher percentages mean a better outcome.

    Measured: 1 hour

  3. Average criterion score

    Average Likert score of two evaluators for each criterion. The maximum score for each case was 40, and the minimum score was 8. higher scores mean a better outcome.

    Measured: 1 hour

Secondary outcomes (1)
  1. Overall performance score

    Overall average of all criteria and cases. The maximum score for each case was 40, and the minimum score was 8. higher scores mean a better outcome.

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2026
  2. Study start15 Mar 2026 (estimated)
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
25 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07485465
Sponsor's protocol ID
FSMLYMPHEDEMA
Acronym
CDTL
Status last verified
Mar 2026
First submitted
4 Mar 2026
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Leypold T, Lingens LF, Beier JP, Boos AM. Integrating AI in Lipedema Management: Assessing the Efficacy of GPT-4 as a Consultation Assistant. Life (Basel). 2024 May 20;14(5):646. doi: 10.3390/life14050646.

    PubMed 38792666
  • Eldaly AS, Avila FR, Torres-Guzman RA, Maita K, Garcia JP, Serrano LP, Forte AJ. Artificial intelligence and lymphedema: State of the art. J Clin Transl Res. 2022 Jun 1;8(3):234-242. eCollection 2022 Jun 29.

    PubMed 35813896
  • Wojcik S, Rulkiewicz A, Pruszczyk P, Lisik W, Pobozy M, Domienik-Karlowicz J. Beyond ChatGPT: What does GPT-4 add to healthcare? The dawn of a new era. Cardiol J. 2023;30(6):1018-1025. doi: 10.5603/cj.97515. Epub 2023 Oct 13.

    PubMed 37830256
  • Mesko B. The Impact of Multimodal Large Language Models on Health Care's Future. J Med Internet Res. 2023 Nov 2;25:e52865. doi: 10.2196/52865.

    PubMed 37917126

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphedema and Artificial Intelligence (AI), run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 20 Mar 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 Turkey (Türkiye). 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 Yunus Emre Doğan, MD (+90 506 051 25 00, ynsemredgn91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy rate (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07485465, which also lists 4 linked publications.

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 20 Mar 2026.

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