LymphedemaNCT04552938
LVA on Serum Profiling in Patients With Lymphedema
An observational study of Lymphedema, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The correlation between oxidative stress and increased lymphedematous limb volume lacks supporting evidence. Lymphedema patients are prone to cellulitis. This study aims to investigate the link between oxidative stress, limb volume, and cellulitis after supermicrosurgical lymphaticovenous anastomosis (LVA). Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- pre-LVA and post-LVA
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Apr 2018to 11 Sep 2020
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Written informed consent was obtained from all patients. Between June 2018 and May 2019, 26 patients with lower limb lymphedema confirmed with lymphoscintigraphy were recruited. Patients with upper limb and bilateral lower limb lymphedema were excluded.
Who may be able to join
- patients with lower limb lymphedema confirmed with lymphoscintigraphy
- unilateral lower limb lymphedema
- lymphedema duration > 2 years
- no active infection
- no prophylactic antibiotic use for at least one month before LVA
- no tumor recurrence or metastasis
- no consumption of antioxidants, such as vitamin E or ascorbic acid
Who cannot join
- Patients with upper limb and bilateral lower limb lymphedema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Lymphaticovenous Anastomosis on Serum Profiling in Patients With Lymphedema
The correlation between oxidative stress and increased lymphedematous limb volume lacks supporting evidence. Lymphedema patients are prone to cellulitis. This study aims to investigate the link between oxidative stress, limb volume, and cellulitis after supermicrosurgical lymphaticovenous anastomosis (LVA).
Read the detailed description
In this study, we focused on the changes in serum antioxidant biomarkers before and after LVA, detected by isobaric tags for relative and absolute quantitation (iTRAQ)-based quantitative proteomic analysis, enzyme-linked immunosorbent assay (ELISA), and Oxidative Stress Panel Kit. For clinical correlation, magnetic resonance (MR) volumetry was implemented for precise lymphedematous limb volume measurements. Correlations were made between changes in oxidative stress, limb volume, and cellulitis before and after LVA.
- Conditions
- Lymphedema
- Being tested
- pre-LVA, post-LVA
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-LVAOther
Venous serum samples were collected from patients before LVA.
post-LVAOther
Venous serum samples were collected from patients one-month after LVA.
| Study group | Role | What they receive |
|---|---|---|
| Patients underwent supermicrosurgical LVA | Patients underwent supermicrosurgical LVA between June 2018 and May 2019. Receives: Other: pre-LVA; Other: post-LVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
the correlation between post-LVA volume reduction
The primary outcome was determined whether post-LVA volume reduction < 40%
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start11 Apr 2018
- Primary completion1 Jun 2020
- Study completion11 Sep 2020
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.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552938
- Sponsor's protocol ID
- 201800306B0
- Status last verified
- Apr 2018
- First submitted
- 14 Sep 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Lymphaticovenous Anastomosis on Serum Profiling in Patients With Lymphedema
- ClinicalTrials.gov ID
- NCT04552938
- Acronym / sponsor ID
- 201800306B0
- Conditions
- Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 17 Sep 2020 (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.
The correlation between oxidative stress and increased lymphedematous limb volume lacks supporting evidence. Lymphedema patients are prone to cellulitis. This study aims to investigate the link between oxidative stress, limb volume, and cellulitis after supermicrosurgical lymphaticovenous anastomosis (LVA).
Detailed description
In this study, we focused on the changes in serum antioxidant biomarkers before and after LVA, detected by isobaric tags for relative and absolute quantitation (iTRAQ)-based quantitative proteomic analysis, enzyme-linked immunosorbent assay (ELISA), and Oxidative Stress Panel Kit. For clinical correlation, magnetic resonance (MR) volumetry was implemented for precise lymphedematous limb volume measurements. Correlations were made between changes in oxidative stress, limb volume, and cellulitis before and after LVA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients underwent supermicrosurgical LVA | – | Other: pre-LVA, Other: post-LVAPatients underwent supermicrosurgical LVA between June 2018 and May 2019. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Written informed consent was obtained from all patients. Between June 2018 and May 2019, 26 patients with lower limb lymphedema confirmed with lymphoscintigraphy were recruited. Patients with upper limb and bilateral lower limb lymphedema were excluded.
Key inclusion criteria (7 listed)
- patients with lower limb lymphedema confirmed with lymphoscintigraphy
- unilateral lower limb lymphedema
- lymphedema duration > 2 years
- no active infection
- no prophylactic antibiotic use for at least one month before LVA
Key exclusion criteria (1 listed)
- Patients with upper limb and bilateral lower limb lymphedema
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 |
|---|---|---|
| pre-LVAVenous serum samples were collected from patients before LVA. | Other | Patients underwent supermicrosurgical LVA |
| post-LVAVenous serum samples were collected from patients one-month after LVA. | Other | Patients underwent supermicrosurgical LVA |
Primary outcome
the correlation between post-LVA volume reduction
Time frame: 6 months after surgery
The primary outcome was determined whether post-LVA volume reduction < 40%
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 17 Sep 2020.
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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, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 7 inclusion and 1 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 17 Sep 2020. 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 Taiwan. 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?
the correlation between post-LVA volume reduction (time frame: 6 months after surgery). 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 17 Sep 2020.