Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132327
Status:
COMPLETED
Last Update Posted:
2018-12-03
First Post:
2005-08-18
Brief Title:
Analysis of Lyme Disease Lesions
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Analysis of Erythema Migrans Lesions
Status:
COMPLETED
Status Verified Date:
2018-11-29
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will analyze cells from erythema migrans lesions the bulls eye rash of Lyme disease Little is known about what happens in the skin when it is infected with Borrelia burgdorferi the bacteria that cause Lyme disease This study will examine and compare laboratory findings in skin biopsies from people with Lyme disease and from healthy normal volunteers to try to better understand the infection
Healthy volunteers and people with untreated erythema migrans rash who are 18 years of age or older may be eligible for this study
All participants undergo a clinical examination blood tests between two to four skin biopsies removal of a small piece of tissue for laboratory examination and complete two health questionnaires The biopsies are taken from the erythema migrans lesion in patients with Lyme disease and from skin on the legs forearms buttocks or side from healthy volunteers To collect the tissue the skin at the biopsy site is numbed with injection of a local anesthetic and a sharp instrument is then used to remove a round plug of skin about the size of a pencil eraser The wound may be closed with one or two sutures or allowed to heal without sutures The sutures are removed after a week to 10 days
Patients with Lyme disease receive treatment for their condition In addition at the time the sutures are removed and at 4 weeks 6 months and 12 months after their first visit they fill out a questionnaire and have additional blood tests
Healthy volunteers and people with untreated erythema migrans rash who are 18 years of age or older may be eligible for this study
All participants undergo a clinical examination blood tests between two to four skin biopsies removal of a small piece of tissue for laboratory examination and complete two health questionnaires The biopsies are taken from the erythema migrans lesion in patients with Lyme disease and from skin on the legs forearms buttocks or side from healthy volunteers To collect the tissue the skin at the biopsy site is numbed with injection of a local anesthetic and a sharp instrument is then used to remove a round plug of skin about the size of a pencil eraser The wound may be closed with one or two sutures or allowed to heal without sutures The sutures are removed after a week to 10 days
Patients with Lyme disease receive treatment for their condition In addition at the time the sutures are removed and at 4 weeks 6 months and 12 months after their first visit they fill out a questionnaire and have additional blood tests
Detailed Description:
Little is known of the host and the bacteria response in vivo in patients with Lyme disease In an attempt to better understand the pathology of erythema migrans EM we will use a variety of techniques to characterize patterns in skin biopsies from individuals with a diagnosis of EM and compared those to the patterns seen in biopsies from unaffected individuals Biopsies from patients may also be evaluated for B burgdorferi Patients diagnosed with erythema migrans will have between 2 and 4 punch skin biopsies of affected area and will return for 4 follow up visits in the course of a year Therapy for Lyme disease will be offered Healthy volunteers will have a screening visit a visit for the skin biopsies and a follow up visit Patients and healthy volunteers will be compensated for their time and inconvenience
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-I-0219 | None | None | None |