NCT04699734

Brief Summary

The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Sep 2020Dec 2026

Study Start

First participant enrolled

September 8, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 7, 2021

Status Verified

December 1, 2020

Enrollment Period

6.3 years

First QC Date

January 4, 2021

Last Update Submit

January 6, 2021

Conditions

Painful Diabetic NeuropathyNeuropathic PainNeuropathy;Peripheral

Outcome Measures

Primary Outcomes (1)

  • Indication of pain relieved extremity

    Number of participants who indicated the leg with lidocaine as most pain relieved 30 minutes after block And number of participants who indicated the leg with saline as most pain relieved 30 minutes after block

    30 minutes

Secondary Outcomes (5)

  • Pain intensity

    90 minutes

  • Hyperalgesia and allodynia

    90 minutes

  • Pain relief

    45 minutes

  • Pain symptomps

    50 minutes

  • Distribution of evoked pain

    60 minutes

Study Arms (2)

Xylocaine

ACTIVE COMPARATOR

Nerve block

Diagnostic Test: Xylocaine 1%

Isotonic saline

PLACEBO COMPARATOR

Nerve block

Diagnostic Test: NaCl 9mg/ml

Interventions

Xylocaine 1%DIAGNOSTIC_TEST

Nerve block

Xylocaine
NaCl 9mg/mlDIAGNOSTIC_TEST

Nerve block

Isotonic saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older.
  • Probably diabetic neuropathy confirmed using the Toronto criteria in a "conservative manner", i.e. three out of three symptoms/signs of neuropathy must be present (sensory neuropathy symptoms, distal reduced sensibility, reduced ankle reflexes) 7.
  • Definite or probable neuropathic pain for minimum the last 6 months
  • Mean pain intensity at \> 4 NRS the last week17.
  • Since we expect a large effect of the block it is not necessary to discontinue pain medication.

You may not qualify if:

  • Other causes of pain in the same area or other pain that cannot be distinguished from the neuropathic pain.
  • Unable to understand and speak Danish.
  • Non-cooperative.
  • Warfarin or other medication that contraindicate regional anesthesia.
  • Infection in the injection area.
  • Allergy to lidocaine.
  • Pregnancy or lactating (fertile women must to show negative pregnancy test or use anticonception).
  • Severe psychiatric disease e.g. severe depression during the last 6 months.
  • Alcohol or drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Pain Research Center, Aarhus University, Aarhus University Hospital

Aarhus N, Jutland, 8200, Denmark

RECRUITING

Related Publications (1)

  • Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.

    PMID: 20876709BACKGROUND

MeSH Terms

Conditions

Diabetic NeuropathiesNeuralgiaNeuritis

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ellen L Schaldemose, MD

    Danish Pain Research Center, Aarhus University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen L Schaldemose, MD

CONTACT

+45 93501942ells@clin.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 7, 2021

Study Start

September 8, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 7, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)