NCT01088685

Hydrogel Blister Patch Prototype Treatment for Foot Blisters on the Heel

Feasibility Study to Evaluate the Safety and Performance of a Hydrogel Blister Patch Prototype for the Treatment of Foot Blisters

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate the safety and performance of a new blister patch intended to treat blisters on the heel of the foot.

Detailed description

The study will require participation for up to 14 days of participation or less if the blister heals sooner, will recruit 100 subjects with fluid filled blisters on the heel of the foot that are intact and not broken. Some subjects will be asked to have their blisters photographed. All subjects will be required to have their blister unroofed (top layer of skin removed by the physician using sterile instruments). All subjects will receive study product, either test product or a marketed product.

Conditions

• Blister

Interventions

Type	Name	Description
DEVICE	Experimental Blister Patch	Experimental hydrogel blister patch to be applied as needed (at least every 2 days) consecutively until blister heals
DEVICE	Marketed Pflaster	Foot Blister Patch to be applied as needed (at least every 2 days) until blister heals

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-03-17
• Last updated: 2011-10-06

Locations

1 site across 1 country: Germany