Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-31 @ 2:15 AM
Study NCT ID:
NCT00820703
Status:
TERMINATED
Last Update Posted:
2010-08-31
First Post:
2009-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers
Sponsor:
OcuNexus Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Prospective, Double-blind, Vehicle-controlled, Dose-escalation, Single-center Study of the Safety and Clinical Effect of Nexagon® in the Treatment of Participants With Diabetic Foot Ulcers
Status:
TERMINATED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
For business reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetic foot ulcers are sores on the feet that occur in 15% of diabetic patients some time during their lifetime. Once an ulcer develops, the risk of lower-extremity amputation is increased 8-fold in people with diabetes. New treatments that improve the number of ulcers that heal and/or speed up healing are urgently needed. Initial studies with a new drug called Nexagon® (developed by CoDa Therapeutics, Inc.) support the concept that healing of diabetic foot ulcers can be improved with topical application of Nexagon®. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to diabetic foot ulcers at various doses. A proposed randomized controlled trial will randomly allocate (e.g., by the toss of a coin) 24 people with diabetic foot ulcers to Nexagon® (one of three different doses) or vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed over four weeks to monitor their response to the treatment, specifically with regards to the amount of healing that occurs.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: