Lymphoedema Diagnosis and Treatment (CDTL)

March 17, 2026 updated by: Fatih Sultan Mehmet Training and Research Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34704
        • Istanbul Fatih Sultan Mehmet Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour
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.
1 hour
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.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Investigators

  • Principal Investigator: Yunus Emre DOĞAN, MD, Istanbul Fatih Sultan Mehmet Training and Research Hospital
  • Study Chair: Feyza Akan Begoğlu, MD, Istanbul Fatih Sultan Mehmet Training and Research Hospital
  • Study Chair: Mesut Canlı, MD, Istanbul Fatih Sultan Mehmet Training and Research Hospital
  • Study Chair: İlknur Aktaş, MD, Prof., Istanbul Fatih Sultan Mehmet Training and Research Hospital
  • Study Chair: Feyza ÜNLÜ ÖZKAN, MD, Prof., Istanbul Fatih Sultan Mehmet Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSMLYMPHEDEMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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