LymphedemaLYMPH-PROGNCT07878598
Efficacy of Complete Decongestive Therapy for Limb Lymphedema: Response Profile and Predictive Modeling
An observational study of Lymphedema and Secondary Lymphedema, run by Ryazan State Medical University at 1 site in Russia.
Trial summary
Background: Complete decongestive therapy (CDT) is the standard treatment for lymphedema, but response varies by localization and laterality. Data on segmental distribution of therapeutic response and predictors of response are limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema, Secondary Lymphedema, Breast Cancer-Related Lymphedema
- What is being tested?
- Intensive phase of Complete Decongestive Therapy
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2024to 23 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: INCLUSION CRITERIA: * Confirmed diagnosis of secondary lymphedema of upper or lower extremity * At least two visits with circumferential measurements (baseline and post-therapeutic) * ISL lymphedema stage I-III * Patients in complete clinical remission from malignancies were eligible EXCLUSION CRITERIA: * Primary (congenital) lymphedema * Incomplete measurement data * Acute skin and subcutaneous fat infection (erysipelas, cellulitis) at therapy initiation * Decompensated heart failure * Venous thromboembolic complications * Malignant neoplasms in active phase of anti-tumor treatment (active chemotherapy or radiation
Who may be able to join
- Confirmed diagnosis of secondary lymphedema of the upper or lower extremity.
- Availability of at least two visits with circumferential measurements (baseline prior to therapy and post-therapeutic upon completion of the intensive phase).
- Lymphedema stage I-III according to the International Society of Lymphology (ISL) classification.
- Patients in complete clinical remission from malignancies were eligible for inclusion.
Who cannot join
- Primary (congenital) lymphedema.
- Incomplete measurement data.
- Acute skin and subcutaneous fat infection (erysipelas, cellulitis) at the time of therapy initiation.
- Decompensated heart failure.
- Venous thromboembolic complications.
- Malignant neoplasms in the active phase of anti-tumor treatment (active chemotherapy or radiation therapy at the time of inclusion).
Trial locations and contacts
1 site in 1 country.
Russia1 site
Ryazan State Medical University, Ministry of Health of Russia
Ryazan
About this study
Official title: EFFICACY OF COMPLEX PHYSICAL DECONGESTIVE THERAPY FOR LIMB LYMPHEDEMA: RESPONSE PROFILE, COMPARISON BY LOCALIZATION, AND DEVELOPMENT OF A PREDICTIVE MODEL (A RETROSPECTIVE OBSERVATIONAL COHORT STUDY)
Background: Complete decongestive therapy (CDT) is the standard treatment for lymphedema, but response varies by localization and laterality. Data on segmental distribution of therapeutic response and predictors of response are limited. Objective: To evaluate changes in lymphedema indicators after intensive-phase CDT, compare therapeutic response profiles across clinical subgroups, and develop a predictive model of response. Methods: Retrospective observational cohort study of 111 patients with secondary lymphedema: unilateral upper extremity, unilateral lower extremity, bilateral lower extremity. Primary outcome: percentage reduction of excess indicator (PREI) for unilateral groups and relative reduction of sum of circumferences (ΣC) for bilateral group. Secondary outcomes: topographic response profile (7 anatomical points), proportion of clinical responders (≥10%), predictive factors, and predictive model. Expected results: Identification of topographic heterogeneity of response, determination of factors of CDT resistance (especially in bilateral lymphedema), development of a validated predictive model for therapy personalization.
- Conditions
- Lymphedema, Secondary Lymphedema, Breast Cancer-Related Lymphedema, Upper Extremity Lymphedema, Lower Extremity Lymphedema After Gynecologic Cancer Surgery
- Being tested
- Intensive phase of Complete Decongestive Therapy
- Medical subject headings
- Lymphedema, Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive phase of Complete Decongestive TherapyOther
Standardized intensive phase of CDT according to International Society of Lymphology (ISL 2023) guidelines, including: (1) manual lymphatic drainage 45-60 min/session, (2) multilayer short-stretch compression bandaging, (3) remedial exercises in compression bandage, (4) skin care. Administered 5 times per week; duration individually determined by the treating physician based on clinical response (volume plateau or maximal tolerated therapy), typically ranging from 10 to 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Upper Extremity Lymphedema | Patients with secondary unilateral lymphedema of the upper extremity (predominantly post-mastectomy etiology, 95.6%) receiving intensive phase CDT. ISL stages I-III. Receives: Other: Intensive phase of Complete Decongestive Therapy | |
| Unilateral Lower Extremity Lymphedema | Patients with secondary unilateral lymphedema of the lower extremity of various etiologies (trauma, infection, CVI, oncological causes) receiving intensive phase CDT. ISL stages I-III. Receives: Other: Intensive phase of Complete Decongestive Therapy | |
| Bilateral Lower Extremity Lymphedema | Patients with secondary bilateral lymphedema of the lower extremities of predominantly non-oncological etiology (infections 42.9%, CVI 14.3%) receiving intensive phase CDT. 48.6% of patients had ISL stage III. Receives: Other: Intensive phase of Complete Decongestive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Reduction of Limb Excess Size
For unilateral lymphedema: Percentage Reduction of Excess Indicator (PREI), calculated as the percentage decrease in the baseline excess of the Integral Perimeter Indicator (IPI, sum of squared circumferences at 7 standard points A-G) relative to the contralateral limb. For bilateral lymphedema: Relative reduction of the sum of circumferences of both limbs (ΣC) at points A-E, as a healthy contralateral reference is unavailable.
Measured: From baseline to the completion of the intensive phase of CDT (variable duration), assessed up to 28 days (4 weeks) from baseline.
Secondary outcomes (1)
Change in Relative Limb Size Coefficient (ΔRLSC)
Absolute difference in the ratio of the affected limb IPI to the healthy limb IPI before and after CDT (applicable to unilateral groups only). Positive value corresponds to reduction in asymmetry.
Measured: From baseline to the completion of the intensive phase of CDT (variable duration), assessed up to 28 days (4 weeks) from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jan 2024
- Primary completion1 Sep 2026
- Study completion23 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878598
- Sponsor's protocol ID
- LYMPH-PROG
- Acronym
- LYMPH-PROG
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF COMPLEX PHYSICAL DECONGESTIVE THERAPY FOR LIMB LYMPHEDEMA: RESPONSE PROFILE, COMPARISON BY LOCALIZATION, AND DEVELOPMENT OF A PREDICTIVE MODEL (A RETROSPECTIVE OBSERVATIONAL COHORT STUDY)
- ClinicalTrials.gov ID
- NCT07878598
- Acronym / sponsor ID
- LYMPH-PROG / LYMPH-PROG
- Conditions
- Lymphedema, Secondary Lymphedema, Breast Cancer-Related Lymphedema, Upper Extremity Lymphedema, Lower Extremity Lymphedema After Gynecologic Cancer Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 23 Sep 2026 (actual)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Complete decongestive therapy (CDT) is the standard treatment for lymphedema, but response varies by localization and laterality. Data on segmental distribution of therapeutic response and predictors of response are limited. Objective: To evaluate changes in lymphedema indicators after intensive-phase CDT, compare therapeutic response profiles across clinical subgroups, and develop a predictive model of response. Methods: Retrospective observational cohort study of 111 patients with secondary lymphedema: unilateral upper extremity, unilateral lower extremity, bilateral lower extremity. Primary outcome: percentage reduction of excess indicator (PREI) for unilateral groups and relative reduction of sum of circumferences (ΣC) for bilateral group. Secondary outcomes: topographic response profile (7 anatomical points), proportion of clinical responders (≥10%), predictive factors, and predictive model. Expected results: Identification of topographic heterogeneity of response, determination of factors of CDT resistance (especially in bilateral lymphedema), development of a validated predictive model for therapy personalization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unilateral Upper Extremity Lymphedema | – | Other: Intensive phase of Complete Decongestive TherapyPatients with secondary unilateral lymphedema of the upper extremity (predominantly post-mastectomy etiology, 95.6%) receiving intensive phase CDT. ISL stages I-III. |
| Unilateral Lower Extremity Lymphedema | – | Other: Intensive phase of Complete Decongestive TherapyPatients with secondary unilateral lymphedema of the lower extremity of various etiologies (trauma, infection, CVI, oncological causes) receiving intensive phase CDT. ISL stages I-III. |
| Bilateral Lower Extremity Lymphedema | – | Other: Intensive phase of Complete Decongestive TherapyPatients with secondary bilateral lymphedema of the lower extremities of predominantly non-oncological etiology (infections 42.9%, CVI 14.3%) receiving intensive phase CDT. 48.6% of patients had ISL stage III. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- INCLUSION CRITERIA: * Confirmed diagnosis of secondary lymphedema of upper or lower extremity * At least two visits with circumferential measurements (baseline and post-therapeutic) * ISL lymphedema stage I-III * Patients in complete clinical remission from malignancies were eligible EXCLUSION CRITERIA: * Primary (congenital) lymphedema * Incomplete measurement data * Acute skin and subcutaneous fat infection (erysipelas, cellulitis) at therapy initiation * Decompensated heart failure * Venous thromboembolic complications * Malignant neoplasms in active phase of anti-tumor treatment (active chemotherapy or radiation
Key inclusion criteria (4 listed)
- Confirmed diagnosis of secondary lymphedema of the upper or lower extremity.
- Availability of at least two visits with circumferential measurements (baseline prior to therapy and post-therapeutic upon completion of the intensive phase).
- Lymphedema stage I-III according to the International Society of Lymphology (ISL) classification.
- Patients in complete clinical remission from malignancies were eligible for inclusion.
Key exclusion criteria (6 listed)
- Primary (congenital) lymphedema.
- Incomplete measurement data.
- Acute skin and subcutaneous fat infection (erysipelas, cellulitis) at the time of therapy initiation.
- Decompensated heart failure.
- Venous thromboembolic complications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive phase of Complete Decongestive TherapyStandardized intensive phase of CDT according to International Society of Lymphology (ISL 2023) guidelines, including: (1) manual lymphatic drainage 45-60 min/session, (2) multilayer short-stretch compression bandaging, (3) remedial exercises in compression bandage, (4) skin care. Administered 5 times per week; duration individually determined by the treating physician based on clinical response (volume plateau or maximal tolerated therapy), typically ranging from 10 to 21 days. | Other | Bilateral Lower Extremity Lymphedema, Unilateral Lower Extremity Lymphedema, Unilateral Upper Extremity Lymphedema |
Primary outcome
Percentage Reduction of Limb Excess Size
Time frame: From baseline to the completion of the intensive phase of CDT (variable duration), assessed up to 28 days (4 weeks) from baseline.
For unilateral lymphedema: Percentage Reduction of Excess Indicator (PREI), calculated as the percentage decrease in the baseline excess of the Integral Perimeter Indicator (IPI, sum of squared circumferences at 7 standard points A-G) relative to the contralateral limb. For bilateral lymphedema: Relative reduction of the sum of circumferences of both limbs (ΣC) at points A-E, as a healthy contralateral reference is unavailable.
1 secondary outcome
Change in Relative Limb Size Coefficient (ΔRLSC)
Time frame: From baseline to the completion of the intensive phase of CDT (variable duration), assessed up to 28 days (4 weeks) from baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema and Secondary Lymphedema, run by Ryazan State Medical University at 1 site in Russia.
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 6 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: finished, as of the sponsor's last update on 16 Oct 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 Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Reduction of Limb Excess Size (time frame: From baseline to the completion of the intensive phase of CDT (variable duration), assessed up to 28 days (4 weeks) from baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.