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Completed

NCT Number: NCT04588493

Secondary Lymphedema Due to Human Adjuvant Disease

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.

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Key information

Conditions

Lymphedema, Secondary Foreign Bodies Foreign-Body Reaction Granuloma Granuloma, Foreign-Body Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Lymphedema of Leg Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Angeles Pedregal

Mexico City, 10700, Mexico

About this study

Lymphoscintigraphy findings were reported with the Transport index (TI), were any value over 5 will represent abnormalities in lymphatic function.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both sex
  • Over 18 years old
  • History of injection of modelling substances for cosmetic purposes
  • History of lower limb edema

Exclusion criteria

  • History of primary lower limb lymphedema
  • Reject to participate
  • Confirmed other causes of edema

Treatment and study plan

Lower extremity Lymphoscintigraphy

Diagnostic Test

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

Primary outcomes

  1. Transport Index

    Time frame: 4 months

    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

Secondary outcomes

  1. Lower extremity lymphedema index

    Time frame: 4 months

    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

Sponsors and collaborators

Lead sponsor

Hospital Angeles del Pedregal

Other

Registry information

Official study title

Human Adjuvant Disease as a Cause of Secondary Lower Extremity Lymphedema

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 19, 2020
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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