An observational study in Lymphedema, Secondary, Lymphedema of Leg and Granuloma, Foreign-Body, sponsored by Hospital Angeles del Pedregal. Completed at 1 site in Mexico. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Hospital Angeles del Pedregal · Observational
This observational, descriptive, retrospective study the clinical and imaging findings of 10 lower legs of 5 patients with previous history of injection of modeling substances for cosmetic purposes at buttocks and hips ande developed lower limb edema. Lower limb lymphedema index and lymphoscintigraphy findings were evaluated and reported.
Lymphoscintigraphy findings were reported with the Transport index (TI), were any value over 5 will represent abnormalities in lymphatic function.
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's enrollment of 5 is below the median of 103 across 145 observational studies indexed under Lymphedema.
Browse Lymphedema studies →Hospital Angeles del Pedregal is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Patients with history of injection of modeling substances for cosmetic purposes (non Federal Drug Administration-approved substances) in buttocks and presenting lower limb edema
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Exclusion Criteria:
Study of lymphoscintigraphy (LCG) abnormalities in a group of patients with history of infiltration of modeling substances in buttocks and hips and complain about lower extremities edema. LCG was performed and evaluated by a single nuclear medicine specialist through injection of the sulfur nanocolloid Technetium 99m, injected intradermal and interdigital in bilateral toes. Dynamic studies were requested for all patients. Standardized acquisition times at 15, 30, 60 and 120 minutes after injection were taken. The following parameters were considered to obtain the transport index in each pelvic limb: transport kinematics, distribution pattern, index time for the appearance of regional lymph nodes, number and collection of colloids in lymph nodes and presence and quality of the colloid uptake by the lymphatic vessels. Summation of these five components resulted in the transport index, which could range from 0 to 45 points
Transport Index
Transport index in each pelvic limb: transport kinematics, distribution pattern, index time for the appearance of regional lymph nodes, number and collection of colloids in lymph nodes and presence and quality of the colloid uptake by the lymphatic vessels. Summation of these five components resulted in the transport index, which could range from 0 to 45 points; less than 5 means a normal study, higher scores represent abnormal or pathological results
Time frame: 4 months
Lower extremity lymphedema index
For Lower extremity lymphedema (LEL) index we first added up cross-sectional areas of the extremities in 5 parts where circumferences were measured, making an approximation that the cross-sections are perfect circles. We made use of the sum of the cross-sectional area's property of being proportional to the sum of the square of the circumference to simplify the calculation of the formula. Finally, we divided the number by BMI to make corrections for the body type, and the obtained value was defined as the LEL index. Dividing the sum by BMI corrected the index according to the body type. LEL index \< 250 corresponded to LEL stage I, 250 to 300 corresponded to LEL stage II, 300 to 350 corresponded to LEL stage III, and \> 350 corresponded to LEL stage IV
Time frame: 4 months
Plan to share: Yes — Study will be published and we will share the results of transport index and lower limb lymphedema index. Also the standardized method to acquire the lymphoscintigraphic evaluation.
Supporting information: Study protocol, Clinical study report
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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Hospital Angeles del Pedregal