Lymphatic Occlusion Pressure in Lower Limb

NCT02405559 | Unknown Early Phase 1

• 1 other identifier: Ly-Occl-Pressure-2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Lymph flow active or not, depending on the pressure applied

  The sphygmomanometer is connected to a pressure meter, indicating mm of Mercury (Testo® 510 Digital Manometer precision 0.1mmHg.).

  1 minute

Study Arms (1)

Lymphatic occlusion pressure lower limb

EXPERIMENTAL

injection of 100µg Indocyanine Green in the first interdigital space and application of increasing pressure around the leg to visualize at which pressure lymph flow is interrupted.

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

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

Also known as: ICG

Lymphatic occlusion pressure lower limb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• Written informed consent signed

You may not qualify if:

• Coronary disease
• Pregnancy
• Allergy to iodine or to shellfish
• Breastfeeding
• Advanced renal impairment
• Minors
• Thyroid pathology
• Primary and secondary lymphedema anywhere on the body
• Oncologic history
• Familial lymphedema
• Previous surgery on the studied member, causing risk of a subclinical lymphedema

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU St-Pierre - Lymphology Clinic of Brussels

Brussels, 1000, Belgium

Location

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jean-Paul Belgrado

  CHU St-Pierre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Paul Belgrado

CONTACT

belgrado@ulb.ac.be

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: April 1, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

BE (1)