Open prospective, uncontrolled pilot study to assess the tolerability and efficacy of Lymdiaral injektopas (Pascoe-Named) in the treatment of pannicolopatia-edema-fibrosclerotic (PEFS) and venous-lymphatic insufficiency chronic (IVLC)through technical intradermotherapy District (ITD) - tolerability and efficacy of Lymdiaral injektopas

• Conditions: tolerability and efficacy of Lymdiaral Injektopas (Pascoe-Named)

• Registration Number: EUCTR2009-014816-37-IT
• Lead Sponsor: AMED SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

-Age> 18 years -Suffering from IVLC connected to PEFS
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Will be excluded from the study subjects who also have one of the following signs or symptoms or conditions: - Secondary Edema to other diseases (disendocrinopatie, kidney disease, liver disease, connective, heart disease). - Patients suffering from incontinence of hemodynamic precludes saphenous-femoral - Pharmacological treatments in progress that may change the evaluation of results (corticosteroids, estrogen-progestine, Ca-antagonists phlebotonic, diuretics). - History pathological autoimmune disorders, neoplastic and paraneoplastic syndromes. - History pathological positive for allergy to medications in general. - Hypersensitivity to one or more components of the product concerned and the composite. -Pharmacological treatments in progress that may change the evaluation of results (corticosteroids, estrogen-progestine, Ca-antagonists, phlebotonic, diuretics) - In Combination with other methods for the same pathology. - Pregnancy - Breastfeeding - In diet therapy treatment - Participation in other clinical studies during the previous six months - Conditions that in the opinion of the physician evaluator, interfere with the ongoing study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the tolerability of Lymdiaral injektopas (Pascoe-Named) in patients administered with technical IVLC PEFS and ITD;Secondary Objective: Evaluate the efficacy of Lymdiaral injektopas (Pascoe-Named) in patients administered with technical IVLC PEFS and ITD;Primary end point(s): Tolerability of the product Lymdiaral Injektopas(Pascoe-Named)