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Lymphatic Occlusion Pressure in Lower Limb

NCT02405559 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-04-01

No results posted yet for this study

Summary

The lymphatic system is one of the keystones of fluid homeostasis in the interstitium. In analogy with the arterial systolic pressure, the lymphatic pressure can give us information about the functioning of the cardiovascular system and fluid exchange. Actually, knowledge about this physiological parameter is incomplete because of the lack of technology. Former measurement techniques of the lymphatic pressure in the living healthy man were invasive and too complex to be interpreted.

The lymphatic occlusion pressure has to be clarified because lymphedema treatment, concerning the pressure to be applied on the edematous tissue is still based on controversial concepts.

On one hand, techniques such as Manual Lymphatic Drainage, sustain the necessity to apply a very low pressure in order to avoid the squeezing of superficial lymph vessels. On the other hand sustainers of Intermittent Compression Therapy advocate the necessity to apply relatively high pressure to obtain a decongesting effect. These completely opposite opinions triggered us to study lymphatic pressure more thoroughly.

Lymphofluoroscopy (emerging imaging technique in the field of lymphology) is now used since 3 years by the promoters of this study to visualize the architecture of the superficial lymphatic network and the progression of the lymph inside the highlighted vessels. This technique will be used in the present (prospective and multicentric) study to observe the effect of a pressure applied on the lower limb on the displacement of the lymph, and then to determine the occlusion pressure of the lymphatic vessels. The investigators already studied the occlusion pressure of the superficial lymphatic vessels of the upper limb in a previous study. The investigators would like to complete our results with the lower limb.

Conditions

  • Lymphatic Function

Interventions

DRUG

Indocyanine Green

Intradermal injection of Indocyanine Green in the first interdigital space of the studied leg

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Saint Pierre

    lead OTHER

Principal Investigators

  • Jean-Paul Belgrado · CHU St-Pierre

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02405559 on ClinicalTrials.gov