Platelet Rich Plasma, Complex Decongestive Physiotherapy and Low Level Laser in Treatment of Lower Extremity Lymphoedema

March 15, 2019 updated by: Ahmet Akgul, Istanbul University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • Turkey
      • Istanbul, Turkey, 34740
        • Istanbul University Faculty of Health Science

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having lower extremity lymphedema
  • To be older than 18 ages.

Exclusion Criteria:

  • 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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Platelets / Platelet Enriched Plasma Regard (PRP) Method
Procedure: PRP method
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).
Experimental: Complex Decongestive Physiotherapy
Procedure: Low Level Laser

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).
Experimental: Low Level Laser
Procedure: Complex Decongestive Physiotherapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Health-related quality of life
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Lower-extremity-circumference
Time Frame: 12 weeks
12 weeks
Numeric rating scale
Time Frame: 12 weeks
12 weeks
6 minutes walking test
Time Frame: 12 weeks
12 weeks
Tissue dielectric constant Questionnaire
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ahmet Akgul, Prof.Dr., Istanbul University
  • Study Director: Ela Tarakci, Assoc.Dr., Istanbul University
  • Study Director: Nilay Arman, PhD, PT, Istanbul University
  • Study Director: Tugba Civi, PT, Istanbul University
  • Study Director: Musa Cirak, MD, DR, Bakirkoy Dr.Sadi Konuk Education 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TSA-2017-22398

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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