In this study the effect of transdermal lidocaine in patients with painful peripheral diabetic neuropathy will be examined.
Conditions
Interventions
Trade Name: Versatis
Product Name: Versatis
Product Code: LS-001775
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: LIDOCAINE
CAS Number: 137-58-6
Concentration unit: % percent
Concentrati
Sponsors
Wilhelminenspital der Stadt Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - subjects of at least 18 years of age; - subjects who have given there written informet consent; - at baseline female subjects of child bearing potential must be using adequate contraception and must have a negative urine pregnancy test; - pain due to peripherial polyneuropathy at the lower extremities with duration of > = 3 months, whose pain is not adequately controlled (subjects with average pain of >= 4 on a numerical rating scale( 0-10), 0 is no pain, 10 is worst imaginable pain) - intact skin surfacen at the potential patch application sites 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
Exclusion criteria: - pregnant or brest feeding subjects - contraindications to versatis - patiens with severe cardiac disorders ( NYHA >3) - subjects with alcohol or drug abuse or addictive personality - subjects with significant psyciatric disorder - subjects receiving antipsychotic medication - subjects for whom a treatement could alter the degree or nature of pain - subjects who received investigational drug or used investigational device in thirty days prior to studie entry -subjects known to have a condition that in the investigators judgement precludes participation in the studie - subjects unable to comply with the study assessments and to complete the questionnaires - subjects with peripheral vascular disease = III following the Fontaine Classification - subjects with history of slow-healing diabetic foot ulcers or current skin or soft tissue lesions on the foot that will interfere with application of the lidocaine patch and or skin biopsies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that mechanical hyperalgesia and allodynia in patients with painful diabetic neuropathy (assessed before treatment using quantitative-sensory testing) is partly reversed during the chronic treatment with transdermal lidocaine. ;Secondary Objective: - To test the hypothesis that increased thermal perception threshold in patients with painful diabetic neuropathy (assessed before treatment using quantitative-sensory testing) is correlated with the degree of pain reduction during the treatment with transdermal lidocaine compared to diabetic patients with decreased thermal perception thresholds. Are patients with increased thermal thresholds less responsive than those with decreased thresholds and thus allow discrimination of treatment responders and non-responders? - To test the hypothesis that chronic treatment with lidocaine 5% plaster causes epidermal nerve degeneration. ;Primary end point(s): Global patients teatment satisfaction, which is measured as a combination parameter of analgesic efficacy of treatment plus its tolerability, is defined as primary and endpoint variable throughout the study. This global treatment satisfaction is quantified by use of a validate 5-point verbal rating scale, judging the quality of treatment ( from the patients point of view) as either very good, good, satisfactory, poor or as inadequate. Patients who judge their treatment during the study period (on average) at least as good, are considered as good treatment responders for the primary endpoint evaluation. | — |
Countries
Austria
Outcome results
None listed