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

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ClinicalTrials.gov Identifier: NCT03080207
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmet Akgul, Istanbul University

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Lower Extremity Lymphedema Procedure: PRP method Procedure: Low Level Laser Procedure: Complex Decongestive Physiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 17, 2017
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Health-related quality of life [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Lower-extremity-circumference [ Time Frame: 12 weeks ]
  2. Numeric rating scale [ Time Frame: 12 weeks ]
  3. 6 minutes walking test [ Time Frame: 12 weeks ]
  4. Tissue dielectric constant Questionnaire [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080207


Locations
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Turkey
Istanbul University Faculty of Health Science
Istanbul, Turkey, 34740
Sponsors and Collaborators
Istanbul University
Investigators
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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

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Responsible Party: Ahmet Akgul, Prof.Dr., Istanbul University
ClinicalTrials.gov Identifier: NCT03080207     History of Changes
Other Study ID Numbers: TSA-2017-22398
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ahmet Akgul, Istanbul University:
Lower Extremity Lymphedema
Physiotherapy
Complex Decongestive Physiotherapy
Low Level Laser
Platelet rich plasma

Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases