Trial Outcomes & Findings for Prevention Trial Assessing Paper-Tape in Endurance Distances II (Pre-TAPED II) (NCT NCT01945112)
NCT ID: NCT01945112
Last Updated: 2018-12-12
Results Overview
Blister data were collected without regard to whether the foot was right or left.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
128 participants
Primary outcome timeframe
within 7 days of application of tape
Results posted on
2018-12-12
Participant Flow
Unit of analysis: number of sites where tape was applied
Participant milestones
| Measure |
Paper Tape on Right and No Tape on Left Foot
Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
|
Paper Tape on Left and No Tape on Right Foot
Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
|
|---|---|---|
|
Overall Study
STARTED
|
77 153
|
51 87
|
|
Overall Study
COMPLETED
|
77 153
|
51 87
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention Trial Assessing Paper-Tape in Endurance Distances II (Pre-TAPED II)
Baseline characteristics by cohort
| Measure |
Paper Tape
n=128 Participants
Paper was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
|
|---|---|
|
Age, Continuous
|
39.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 7 days of application of tapeBlister data were collected without regard to whether the foot was right or left.
Outcome measures
| Measure |
Paper Tape
n=128 Participants
Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
|
|---|---|
|
Count of Participants With Any Foot Blister in Taped or Untaped Area of the Foot
Blister anywhere
|
106 Participants
|
|
Count of Participants With Any Foot Blister in Taped or Untaped Area of the Foot
Blister in taped area
|
30 Participants
|
|
Count of Participants With Any Foot Blister in Taped or Untaped Area of the Foot
Blister in untaped area
|
81 Participants
|
Adverse Events
Paper Tape on RIght Foot and No Tape on Left Foot
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tape on Left Foot and No Tape on Right Foot
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place