NCT00971048

Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Healthpoint · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare HP828-101 to standard of care for the management of partial or full thickness wounds

Detailed description

The primary objective is to compare HP828-101 to standard of care for the management of partial or full thickness wounds, evaluated using the Bates Jensen Wound Assessment Tool (BWAT). The secondary objectives are comparison of the proportion of subjects with wound closure by day 22, comparison of pain assessed using a visual analog scale (VAS), and evaluation of moist wound environment as per the BWAT.

Conditions

• Diabetic Foot Ulcers
• Pressure Ulcers

Interventions

Type	Name	Description
DEVICE	HP828-101	Topical test article applied once daily
DEVICE	Hydrogel/Hydrocolloid	Hydrogel for DFU and Hydrocolloid for PU (3M Tegaderm Hydrogel for DFU; ConvaTec DuoDERM Hydroactive Gel for PU); Topical test articles applied once daily

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-09-03
• Last updated: 2014-01-27
• Results posted: 2014-01-27

Locations

11 sites across 1 country: United States