Lower Extremity LymphedemaNCT07014566
Effectiveness of Digital Physiotherapy in the Short and Long-Term Management of Lower Extremity Lymphedema
A study testing Digital Combined Decongestive Therapy in people with Lower Extremity Lymphedema, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This study investigated the short- and long-term effects of digital physiotherapy in patients with unilateral and bilateral lower extremity lymphedema. Limb volume and quality of life were assessed at baseline, post-treatment, and 12-week follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lower Extremity Lymphedema
- What is being tested?
- Digital Combined Decongestive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2019to 22 Nov 2024
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with unilateral lower extremity lymphedema (either primary or secondary)
- Patients aged 18 years or older
Who cannot join
- Presence of metastatic disease
- History of coronary heart disease, pulmonary disease, or acute infection of any cause
- Presence of peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
This study investigated the short- and long-term effects of digital physiotherapy in patients with unilateral and bilateral lower extremity lymphedema. Limb volume and quality of life were assessed at baseline, post-treatment, and 12-week follow-up.
Read the detailed description
This study evaluated the feasibility and effectiveness of a digital physiotherapy program based on combined decongestive therapy in patients with lower extremity lymphedema. After an initial face-to-face training session on self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care, patients followed a 4-week digital physiotherapy program with remote supervision. Compression stockings were used during the maintenance phase. Limb volume was measured using circumference method. Quality of life was assessed with the Lymphoedema functioning, disability and health questionnaire questionnaire. Assessments were repeated post-treatment and at 12-week follow-up.
- Conditions
- Lower Extremity Lymphedema
- Being tested
- Digital Combined Decongestive Therapy
- Keywords
- Lower extremity lymphedema, Digital physiotherapy, Combined decongestive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Combined Decongestive TherapyOther
The intervention consisted of a digitally delivered combined decongestive therapy (CDT) program for patients with unilateral or bilateral lower extremity lymphedema. Patients attended a single face-to-face session where a physiotherapist provided training on skin care, self-bandaging, self-manual lymphatic drainage, and therapeutic exercises (breathing, gluteal sets, knee sets, and toe movements). Caregivers recorded the demonstrations for home use. Following this session, a 4-week remote physiotherapy program was implemented using telecommunication technologies. Patients continued self-management with guidance via digital platforms. Compression stockings replaced self-bandaging during the 12-week follow-up phase.
| Study group | Role | What they receive |
|---|---|---|
| Digital Combined Decongestive Therapy Group | Experimental | Patients received digital combined decongestive therapy, including self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care education, with remote supervision over 4 weeks, followed by a maintenance phase with compression stockings. Receives: Other: Digital Combined Decongestive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Limb Volume
Limb volume was assessed by measuring the circumference of the affected arm at 4-cm intervals from the ulnar styloid to the axillary region using a standard tape measure. These measurements were used to calculate the total limb volume to evaluate changes after the intervention and at follow-up.
Measured: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)
Secondary outcomes (1)
Change in Quality of Life
Quality of life was assessed using the Turkish version of the Lymphedema Functioning, Disability and Health Questionnaire (Lymph-ICF), which is specific to lymphedema. The scale consists of 29 items across five domains: physical function, mental function, household activities, mobility activities, and social life. Each item was scored on a 0-100 mm visual analog scale (VAS), where higher scores indicate greater impairment and reduced quality of life.
Measured: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start5 Feb 2019
- Primary completion15 Oct 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity LymphedemaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selva Otsay, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014566
- Sponsor's protocol ID
- Lenfödemalt2025
- Status last verified
- Feb 2019
- First submitted
- 3 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu X, Liu Y, Zhu D, Wang F, Ji J, Yan H. Early prevention of complex decongestive therapy and rehabilitation exercise for prevention of lower extremity lymphedema after operation of gynecologic cancer. Asian J Surg. 2021 Jan;44(1):111-115. doi: 10.1016/j.asjsur.2020.03.022. Epub 2020 May 10.
PubMed 32402630
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Digital Physiotherapy in the Short and Long-Term Management of Lower Extremity Lymphedema
- ClinicalTrials.gov ID
- NCT07014566
- Acronym / sponsor ID
- Lenfödemalt2025
- Conditions
- Lower Extremity Lymphedema
- Keywords
- Lower extremity lymphedema, Digital physiotherapy, Combined decongestive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 11 Jun 2025 (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.
This study investigated the short- and long-term effects of digital physiotherapy in patients with unilateral and bilateral lower extremity lymphedema. Limb volume and quality of life were assessed at baseline, post-treatment, and 12-week follow-up.
Detailed description
This study evaluated the feasibility and effectiveness of a digital physiotherapy program based on combined decongestive therapy in patients with lower extremity lymphedema. After an initial face-to-face training session on self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care, patients followed a 4-week digital physiotherapy program with remote supervision. Compression stockings were used during the maintenance phase. Limb volume was measured using circumference method. Quality of life was assessed with the Lymphoedema functioning, disability and health questionnaire questionnaire. Assessments were repeated post-treatment and at 12-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Combined Decongestive Therapy Group | Experimental | Other: Digital Combined Decongestive TherapyPatients received digital combined decongestive therapy, including self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care education, with remote supervision over 4 weeks, followed by a maintenance phase with compression stockings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with unilateral lower extremity lymphedema (either primary or secondary)
- Patients aged 18 years or older
Key exclusion criteria (3 listed)
- Presence of metastatic disease
- History of coronary heart disease, pulmonary disease, or acute infection of any cause
- Presence of peripheral neuropathy
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 |
|---|---|---|
| Digital Combined Decongestive TherapyThe intervention consisted of a digitally delivered combined decongestive therapy (CDT) program for patients with unilateral or bilateral lower extremity lymphedema. Patients attended a single face-to-face session where a physiotherapist provided training on skin care, self-bandaging, self-manual lymphatic drainage, and therapeutic exercises (breathing, gluteal sets, knee sets, and toe movements). Caregivers recorded the demonstrations for home use. Following this session, a 4-week remote physiotherapy program was implemented using telecommunication technologies. Patients continued self-management with guidance via digital platforms. Compression stockings replaced self-bandaging during the 12-week follow-up phase. | Other | Digital Combined Decongestive Therapy Group |
Primary outcome
Change in Limb Volume
Time frame: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)
Limb volume was assessed by measuring the circumference of the affected arm at 4-cm intervals from the ulnar styloid to the axillary region using a standard tape measure. These measurements were used to calculate the total limb volume to evaluate changes after the intervention and at follow-up.
1 secondary outcome
Change in Quality of Life
Time frame: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)
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 11 Jun 2025.
- Background: PubMed 32402630Wu X, Liu Y, Zhu D, Wang F, Ji J, Yan H. Early prevention of complex decongestive therapy and rehabilitation exercise for prevention of lower extremity lymphedema after operation of gynecologic cancer. Asian J Surg. 2021 Jan;44(1):111-115. doi: 10.1016/j.asjsur.2020.03.022. Epub 2020 May 10.
- Individual participant dataSharing planned: No
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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?
A study testing Digital Combined Decongestive Therapy in people with Lower Extremity Lymphedema, run by Bezmialem Vakif University 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 2 inclusion and 3 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 11 Jun 2025. 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?
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?
Change in Limb Volume (time frame: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)). 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 NCT07014566, which also lists 1 linked publication.
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 11 Jun 2025.