Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256575
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-02-05
Brief Title:
Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis
Sponsor:
Primus Pharmaceuticals
Organization:
Primus Pharmaceuticals
Study Overview
Official Title:
Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin A Randomized Double-blind Placebo-controlled Multi-centre Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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 is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis scleroderma and open sores on their fingers digital ulcers Two 2 out of three 3 participants will receive active product The participants will have four 4 visits over eight 8 weeks Physical exams and photos will be performed A variety of questions will be asked describing level of pain and lifestyle changes
Detailed Description:
This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis scleroderma and open sores on their fingers digital ulcers The study will include 21-45 participants randomly given active product or inactive product placebo Two 2 out of every three 3 participants enrolled will receive active product The participants will have four 4 visits over eight 8 weeks At each visit physical exams and photos will be performed Each person will also be asked a variety of questions describing level of pain and any changes to their lifestyle
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?:
False
Is an FDA AA801 Violation?:
None