Secondary Lymphedema Due to Human Adjuvant Disease

Lymphedema of Leg Clinical Trial

Official title:

Human Adjuvant Disease as a Cause of Secondary Lower Extremity Lymphedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04588493
• Other study ID #: HAD and lymphedema
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: October 2020
• Source: Hospital Angeles del Pedregal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Foreign Bodies
• Granuloma
• Granuloma, Foreign-Body
• Lymphedema
• Lymphedema of Leg
• Lymphedema, Secondary
• Neoplasm Metastasis

Intervention

Diagnostic Test:
• Lower extremity Lymphoscintigraphy
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

Locations

Country	Name	City	State
Mexico	Hospital Angeles Pedregal	Mexico City	Cdmx

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Angeles del Pedregal

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 months
Secondary	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	4 months