sing the Stem Cells to Cure Lower Limb Lymphedema
Not Applicable
Recruiting
- Registration Number
- IRCT20171023036966N1
- Lead Sponsor
- Hematology,Oncology and Stem Cell Transplantation Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
primary lower extremities lymphedema (stage < III)
Exclusion Criteria
Uncontrolled hypertension
Diabetes
Sever heart failure (EF<30 %)
Coronary arterial disease
Chronic renal disease
History of any malignancies over the last 10 years
History of chemo/radiotherapy in the last 10 years
Organ transplantations in the last 10 years
Active infection of the lower extremities
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Circumference of the lymphedematous lower extremity in specific distances of the limb length. Timepoint: Before intervention and then monthly up to 9 months. Method of measurement: Tape measuring.;Volume of the Circumference of the lymphedematous lower extremity. Timepoint: Before intervention and then monthly up to 9 months. Method of measurement: Volume of truncated cone formula.
- Secondary Outcome Measures
Name Time Method Quality of life. Timepoint: Before intervention and end of the follow up time (9 months after intervention). Method of measurement: WHO QOL questionnaire (SF 26).;Lymphoscintigraphic Transport Index (TI). Timepoint: Before intervention and end of the follow up time (9 months after intervention). Method of measurement: Report of lymphoscintigraphy by the expert nuclear medicine specialist.;Average number of subcutaneous lymphatic vessels of the lower extremities. Timepoint: Before intervention and end of the follow up time (9 months after intervention). Method of measurement: Histopathologic investigation and immunohistochemistery (IHC) staining by the expert pathologist.