Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06328166
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2023-12-03
Brief Title:
The Effect and Safety of Recombinant Fibroblast Growth Factor-1 for Carpal Tunnel Syndrome
Sponsor:
Tri-Service General Hospital
Organization:
Tri-Service General Hospital
Study Overview
Official Title:
The Effect and Safety of Recombinant Human Fibroblast Growth Factor-1 for Patient With Carpal Tunnel Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Carpal tunnel syndrome CTS is a common peripheral entrapment mononeuropathy of the upper limb which results from compression of median nerve at level of wrist In recent years regenerative medicine has gradually been applied in the treatment of various degenerative conditions such as bones muscles and nerves Human fibroblast growth factor 1 is a single-chain protein which has been shown to play a crucial regulatory role in the brain and spinal cord and can facilitate nerve cell differentiation and growth ES135 is a recombinant human fibroblast growth factor 1 rhFGF1 which is composed of 135 amino acids with a molecular weight of approximately 152 kilodalton Several studies have shown that significant improvement of Functional Independence Measure motor and sensory function of spinal cord injury patients after ES135 treatment One study also revealed the muscle strength have significant improvement in brachial plexus injury patients after ES135 therapy According to above studies the investigators hypothesized that ES135 may have benefits to CTS patients Hence the purpose of this study aim to demonstrate the therapeutic effects and safety of ES135 for CTS
Detailed Description:
Participants established with diagnosis of mild-to-moderate CTS will been randomly assigned to ES135 or Placebo groups With ultrasound guidance injection with ES135 or Placebo was performed between median nerve and transcarpal ligament The Boston Carpal Tunnel Syndrome Questionnaire is assigned as primary outcome The secondary outcomes encompass visual analog scale electrophysiological studies and cross-sectional area of the median nerve The assessment is performed prior injection and at 1 2 3 4 and 6 months post-injection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None