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NCT Number: NCT07485465

Lymphoedema Diagnosis and Treatment

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34704, Turkey (Türkiye)

Location contact

İlknur Aktaş, MD, Prof.

CONTACT

[email protected]

+90 533 714 63 52

About this study

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:

  • Accuracy and adequacy of clinical summary
  • Accuracy of primary diagnosis
  • Accuracy of differential diagnosis table
  • Appropriateness of recommended diagnostic tests
  • Concordance of treatment plan with current guidelines
  • Appropriateness of compression class/exercise-diet recommendations
  • Adequacy of red flags
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Other

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.

Primary outcomes

  1. Diagnostic accuracy rate

    Time frame: 1 hour

    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.

  2. Treatment adequacy rate

    Time frame: 1 hour

    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.

  3. Average criterion score

    Time frame: 1 hour

    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.

Secondary outcomes

  1. Overall performance score

    Time frame: 1 hour

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yunus Emre Doğan, MD

CONTACT

[email protected]

+90 506 051 25 00

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Official study title

The Role of Chat GPT in the Diagnosis and Treatment of Lymphedema

Acronym: CDTL

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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