Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-28 @ 2:42 PM
Study NCT ID:
NCT00238550
Status:
COMPLETED
Last Update Posted:
2022-06-13
First Post:
2005-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of CBME in the Relief of Painful Diabetic Neuropathy
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Study Overview
Official Title:
Randomised Control Trial Studying the Addition of CBME to Conventional Treatment for the Relief of Painful Diabetic Neuropathy
Status:
COMPLETED
Status Verified Date:
2022-06
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:
The study is designed to investigate the benefit of adding CBME to the existing treatment regime in the management of painful neuropathy.
Hypothesis:
1. The addition of CBME to the existing treatment regime will result in a significant improvement in both primary and secondary outcome measures.
2. The side effect profile and tolerability of CBME will be minimal and comparable to placebo.
Hypothesis:
1. The addition of CBME to the existing treatment regime will result in a significant improvement in both primary and secondary outcome measures.
2. The side effect profile and tolerability of CBME will be minimal and comparable to placebo.
Detailed Description:
1. To investigate the benefit of adding CBME to the existing treatment regime in the management of painful neuropathy.
2. To study the tolerability and side effect profile of CBME.
3. To study the effects of CBME treatment on vibration perception thresholds (VPT) and nerve conduction study parameters.
4. To evaluate the effects of CBME on central nervous system deep nuclei using MR Spectroscopy.
2. To study the tolerability and side effect profile of CBME.
3. To study the effects of CBME treatment on vibration perception thresholds (VPT) and nerve conduction study parameters.
4. To evaluate the effects of CBME on central nervous system deep nuclei using MR Spectroscopy.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BDA:RD03/0002590 | None | None | View |