Study to evaluate the safety and performance of a new blister patch intended to treat blisters on the heel of the foot.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
93
Experimental hydrogel blister patch to be applied as needed (at least every 2 days) consecutively until blister heals
Foot Blister Patch to be applied as needed (at least every 2 days) until blister heals
SCIderm GmbH
Hamburg, Germany
Investigator Assessment
Global assessment of the product by the investigator at the subject's last visit.
Time frame: at subject's last visit, within 14 days of start
Subject Assessment
Global assessment of the product by the subject at the subject's last visit.
Time frame: at subject's last visit, within 14 days of start
Time to Heal
Record of the time it took for the blister to heal within the 14-day study period.
Time frame: Baseline to subject's last visit, within 14 days of start
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