NCT01437332

Brief Summary

Specific proteins and other signaling molecules are increased and decreased following nerve injury. Some of these are important in producing pain or explaining why pain persists after traumatic nerve injuries or in disease states such as diabetes. In this study, the investigators hypothesize that it is possible to detect changes in specific signaling molecules and that these will provide insights into novel treatment strategies. The patients to be included are those who are undergoing the removal of tissue during surgery. The tissues that would otherwise be discarded will be included in the study as appropriate.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

September 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Last Updated

September 20, 2011

Status Verified

September 1, 2011

Enrollment Period

5 years

First QC Date

September 19, 2011

Last Update Submit

September 19, 2011

Conditions

DiabetesNerve InjuryChronic Neuropathic Pain

Study Arms (3)

Diabetes

Nerve injury

Other

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgical procedures at Rambam Health Care Campus wherein the surgeon and PI determine appropriateness for study

You may qualify if:

  • patients undergoing surgery where tissue removal is anticipated

You may not qualify if:

  • age younger than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Related Publications (1)

  • Ebenezer GJ, McArthur JC, Thomas D, Murinson B, Hauer P, Polydefkis M, Griffin JW. Denervation of skin in neuropathies: the sequence of axonal and Schwann cell changes in skin biopsies. Brain. 2007 Oct;130(Pt 10):2703-14. doi: 10.1093/brain/awm199.

    PMID: 17898011BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2011

First Posted

September 20, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2016

Last Updated

September 20, 2011

Record last verified: 2011-09

Locations

IL(1)