Lower Extremity LymphedemaNCT03080207
Platelet Rich Plasma, Complex Decongestive Physiotherapy and Low Level Laser in Treatment of Lower Extremity Lymphoedema
A study testing PRP method, Low Level Laser and Complex Decongestive Physiotherapy in people with Lower Extremity Lymphedema, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
At the end of the study, comparative information about the effects of PRP, complex decongestive physiotherapy and low level laser on edema volume, range of motion, muscle strength, functional capacity and quality of life will be obtained in the treatment of patients with lower limb lymphedema. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lower Extremity Lymphedema
- What is being tested?
- PRP method, Low Level Laser and Complex Decongestive Physiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2017to 1 Jan 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having lower extremity lymphedema
- To be older than 18 ages.
Who cannot join
- Having received radiotherapy treatment in the last 6 months,
- Having received physiotherapy treatment in the last 6 months,
- General health status is not eligible for treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Faculty of Health Science
Istanbul, 34740
About this study
Official title: Comparison of Efficacy of Platelets / Platelet Enriched Plasma Regard (PRP) Method, Complex Decongestive Physiotherapy and Low Level Laser in Treatment of Lower Extremity Lymphoedema
At the end of the study, comparative information about the effects of PRP, complex decongestive physiotherapy and low level laser on edema volume, range of motion, muscle strength, functional capacity and quality of life will be obtained in the treatment of patients with lower limb lymphedema.
Since there is no study about this field in the literature, this study will provide new and valuable contributions about treatment of lower extremity lymphedema for the researchers and clinicians.
- Conditions
- Lower Extremity Lymphedema
- Being tested
- PRP method, Low Level Laser, Complex Decongestive Physiotherapy
- Keywords
- Lower Extremity Lymphedema, Physiotherapy, Complex Decongestive Physiotherapy, Low Level Laser, Platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP methodProcedure or surgery
It will first be placed on a 25 cc venous blood centrifuge in anticoagulated tubes containing acid citrate dextrose (ACD), and autologous venous blood will be centrifuged at 3200 rpm for 15 minutes. Using the PRP kit, the plasma rich in platelet volume of about 3 cc volume will be removed. This will be activated by the addition of platelet agonists such as thrombin, calcium gluconate or calcium chloride. Injections should be administered subcutaneously for 2-3 weeks, 3-4 times for inguinal, popliteal region and ankle for a total of 12 weeks. Also, all patients in this groups have received Complex Decongestive Physiotherapy (Manual lymph drainage (MLD), skin care, compression therapy and active therapeutic exercise).
Low Level LaserProcedure or surgery
Low Density Laser treatment will be applied for the first 4 weeks every 12 weeks, the remaining 8 weeks 2 days / week. A total of 9 regions (6 point inguinal region and 3 points popliteal region) are to be applied by applying the laser head close to the skin (20000 Hz, 1.5 J / cm2) with the laser device and the regions where lymph nodes and lymph pathways are dense.
During the application, the patient will be in the supine position for the popliteal region, with the patient in the supine position for the inguinal region and the legs free in the abdomen.Also, all patients in this groups have received Complex Decongestive Physiotherapy (Manual lymph drainage (MLD), skin care, compression therapy and active therapeutic exercise).
Complex Decongestive PhysiotherapyProcedure or surgery
Complex Decongestive Physiotherapy (CDP) consists of four basic components and two phases. Four basic components; Manual lymph drainage (MLD), skin care, compression therapy and therapeutic exercise. Phase I (intense phase): It is also referred to as the phase of reducing the remission. In this phase, skin care and compression bandages are renewed after daily MLD application. The patient is taught how to bandage on his own. (Phase I, 4 weeks) The duration of phase I may vary according to the patient. In Phase II, MLD can be administered 2 or 3 times per week depending on the needs of the individual. In this case, the patient is followed by home program. Our cases will be treated in Phase I every day for 12 weeks in total and 2 days / week in Phase II according to KBF phases. All patients in this group have received only Complex Decongestive Physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Platelets / Platelet Enriched Plasma Regard (PRP) Method | Experimental | Not described Receives: Procedure: PRP method |
| Complex Decongestive Physiotherapy | Experimental | Not described Receives: Procedure: Low Level Laser |
| Low Level Laser | Experimental | Not described Receives: Procedure: Complex Decongestive Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
Measured: 12 weeks
Secondary outcomes (4)
Lower-extremity-circumference
Measured: 12 weeks
Numeric rating scale
Measured: 12 weeks
6 minutes walking test
Measured: 12 weeks
Tissue dielectric constant Questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start17 Jan 2017
- Primary completion1 Aug 2017
- Study completion1 Jan 2018
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Akgul, Istanbul University
- Investigators
- Ahmet Akgul, Prof.Dr., Principal investigator, Istanbul UniversityEla Tarakci, Assoc.Dr., Study director, Istanbul UniversityNilay Arman, PhD, PT, Study director, Istanbul UniversityTugba Civi, PT, Study director, Istanbul UniversityMusa Cirak, MD, DR, Study director, Bakirkoy Dr.Sadi Konuk Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080207
- Sponsor's protocol ID
- TSA-2017-22398
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2017
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akgul A, Tarakci E, Arman N, Civi T, Irmak S. A Randomized Controlled Trial Comparing Platelet-Rich Plasma, Low-Level Laser Therapy, and Complex Decongestive Physiotherapy in Patients with Lower Limb Lymphedema. Lymphat Res Biol. 2020 Oct;18(5):439-447. doi: 10.1089/lrb.2019.0064. Epub 2020 Feb 19.
PubMed 32073990
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Platelets / Platelet Enriched Plasma Regard (PRP) Method, Complex Decongestive Physiotherapy and Low Level Laser in Treatment of Lower Extremity Lymphoedema
- ClinicalTrials.gov ID
- NCT03080207
- Acronym / sponsor ID
- TSA-2017-22398
- Conditions
- Lower Extremity Lymphedema
- Keywords
- Lower Extremity Lymphedema, Physiotherapy, Complex Decongestive Physiotherapy, Low Level Laser, Platelet rich plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 15 Mar 2017 (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.
At the end of the study, comparative information about the effects of PRP, complex decongestive physiotherapy and low level laser on edema volume, range of motion, muscle strength, functional capacity and quality of life will be obtained in the treatment of patients with lower limb lymphedema.
Since there is no study about this field in the literature, this study will provide new and valuable contributions about treatment of lower extremity lymphedema for the researchers and clinicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Platelets / Platelet Enriched Plasma Regard (PRP) Method | Experimental | Procedure: PRP method |
| Complex Decongestive Physiotherapy | Experimental | Procedure: Low Level Laser |
| Low Level Laser | Experimental | Procedure: Complex Decongestive Physiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having lower extremity lymphedema
- To be older than 18 ages.
Key exclusion criteria (3 listed)
- Having received radiotherapy treatment in the last 6 months,
- Having received physiotherapy treatment in the last 6 months,
- General health status is not eligible for treatment
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 |
|---|---|---|
| PRP methodIt will first be placed on a 25 cc venous blood centrifuge in anticoagulated tubes containing acid citrate dextrose (ACD), and autologous venous blood will be centrifuged at 3200 rpm for 15 minutes. Using the PRP kit, the plasma rich in platelet volume of about 3 cc volume will be removed. This will be activated by the addition of platelet agonists such as thrombin, calcium gluconate or calcium chloride. Injections should be administered subcutaneously for 2-3 weeks, 3-4 times for inguinal, popliteal region and ankle for a total of 12 weeks. Also, all patients in this groups have received Complex Decongestive Physiotherapy (Manual lymph drainage (MLD), skin care, compression therapy and active therapeutic exercise). | Procedure or surgery | Platelets / Platelet Enriched Plasma Regard (PRP) Method |
| Low Level LaserLow Density Laser treatment will be applied for the first 4 weeks every 12 weeks, the remaining 8 weeks 2 days / week. A total of 9 regions (6 point inguinal region and 3 points popliteal region) are to be applied by applying the laser head close to the skin (20000 Hz, 1.5 J / cm2) with the laser device and the regions where lymph nodes and lymph pathways are dense. During the application, the patient will be in the supine position for the popliteal region, with the patient in the supine position for the inguinal region and the legs free in the abdomen.Also, all patients in this groups have received Complex Decongestive Physiotherapy (Manual lymph drainage (MLD), skin care, compression therapy and active therapeutic exercise). | Procedure or surgery | Complex Decongestive Physiotherapy |
| Complex Decongestive PhysiotherapyComplex Decongestive Physiotherapy (CDP) consists of four basic components and two phases. Four basic components; Manual lymph drainage (MLD), skin care, compression therapy and therapeutic exercise. Phase I (intense phase): It is also referred to as the phase of reducing the remission. In this phase, skin care and compression bandages are renewed after daily MLD application. The patient is taught how to bandage on his own. (Phase I, 4 weeks) The duration of phase I may vary according to the patient. In Phase II, MLD can be administered 2 or 3 times per week depending on the needs of the individual. In this case, the patient is followed by home program. Our cases will be treated in Phase I every day for 12 weeks in total and 2 days / week in Phase II according to KBF phases. All patients in this group have received only Complex Decongestive Physiotherapy. | Procedure or surgery | Low Level Laser |
Primary outcome
Health-related quality of life
Time frame: 12 weeks
4 secondary outcomes
Lower-extremity-circumference
Time frame: 12 weeks
Numeric rating scale
Time frame: 12 weeks
6 minutes walking test
Time frame: 12 weeks
Tissue dielectric constant Questionnaire
Time frame: 12 weeks
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 19 Mar 2019.
- Derived from this study: PubMed 32073990Akgul A, Tarakci E, Arman N, Civi T, Irmak S. A Randomized Controlled Trial Comparing Platelet-Rich Plasma, Low-Level Laser Therapy, and Complex Decongestive Physiotherapy in Patients with Lower Limb Lymphedema. Lymphat Res Biol. 2020 Oct;18(5):439-447. doi: 10.1089/lrb.2019.0064. Epub 2020 Feb 19.
- 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.
Ahmet Akgul, Prof.Dr. principal investigator
Istanbul University
Ela Tarakci, Assoc.Dr. study director
Istanbul University
Nilay Arman, PhD, PT study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP method, Low Level Laser and Complex Decongestive Physiotherapy in people with Lower Extremity Lymphedema, run by Istanbul 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 19 Mar 2019. 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?
Health-related quality of life (time frame: 12 weeks). 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 NCT03080207, 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 19 Mar 2019.