Clinical Trial: A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
Brief Summary: Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers
Detailed Summary:
Sponsor: Healthpoint
Current Primary Outcome: Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247 [ Time Frame: Wound fluid samples were to be collected one week after the initial dose of HP802-247. ]
Original Primary Outcome:
- Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247 [ Time Frame: 5 weeks ]
- = Determine change from baseline in cell types in subjects with VLU following the first dose of HP802-247 [ Time Frame: 5 weeks ]
- = Determine change from baseline in biochemical markers of inflammation in subjects with VLU following the first dose of HP802-247 [ Time Frame: 5 weeks ]
Current Secondary Outcome:
Original Secondary Outcome: Wound closure, defined as complete re-epithelization with no drainage or need for a dressing, will be recorded as a secondary outcome measure following up to 12 weeks of dosing [ Time Frame: 12 weeks ]
Information By: Healthpoint
Dates:
Date Received: May 28, 2014
Date Started: July 2014
Date Completion:
Last Updated: September 19, 2016
Last Verified: September 2016