SEXI: Sciatic Expression and Identification of Differential Proteins in Traumatized Versus Nontraumatized Nerves

NCT01710618 | Unknown

• 1 other identifier: 359367-12
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to elucidate the different proteins that may appear on the "injured" end of the sciatic nerve and compare it to the other end of the cut nerve, which is "uninjured". By comparing the "normal" versus "traumatized" ends of the cut sciatic nerve, the investigators hope to identify proteins that may be specifically related to pain. For instance, if the non-traumatized end of the nerve has none of Protein X but the traumatized end of the nerve has a lot of Protein X, then Protein X would be a protein that the investigators will want to study further and see if it plays any role in the sensation of pain. Other studies have shown that there are specific pain-related proteins and they may be increased or decreased after traumatic injury. If the investigators are able to identify specific proteins that are related to pain, then that may eventually lead to the development of medications that will block those proteins and decrease the sensation of pain.

Conditions

Pain

Keywords

Protein Expression of Sciatic Nerve; traumatized sciatic nerve

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female Operation Iraqi Freedom (OIF)/(Operation New Dawn (OND) or Operation Enduring Freedom (OEF) veterans who meet eligibility criteria who require an amputation revision occurring during their initial hospital admission.

You may qualify if:

• Males and females 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy
• Written informed consent must be obtained from each subject prior to entering the study
• Traumatic lower extremity (above knee or below knee) amputation that occurred as a result of exposure to improvised explosive device (IED) blast, gunshot, or vehicle rollover during combat in support of OIF/OND or OEF.
• Scheduled final amputation revision to occur during the initial hospital admission at Walter Reed National Military Medical Center

You may not qualify if:

• Inability to provide informed consent
• Traumatic or surgical foot amputations
• Amputation occurring at Walter Reed Army Medical Center or another continental United States (CONUS) hospital after failed limb salvage
• Nerve specimen less than 5cm in length

Sponsors & Collaborators

• Defense and Veterans Center for Integrative Pain Management: lead
• Duke University: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

sciatic nerve specimen will be obtained

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chester c Buckenmaier

  Defense and Veterans Center for Integrative Pain Management

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 19, 2012
• Study Start: July 1, 2011
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)