- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01945112
Prevention Trial Assessing Paper-Tape in Endurance Distances II (Pre-TAPED II)
Study Overview
Detailed Description
Participants will be ultra-endurance athletes competing in Racing the Planet's 250 mile/7 day 4 Desert events in 2014 (Jordan, Gobi, Madagascar, and Atacama. A convenience sample will be used, with full consent signed before inclusion into the study, with participants being informed that study inclusion is entirely optional and will not affect medical care. Randomization will be conducted for each participant, a coin will be flipped to determine which foot is to be taped, heads - right foot, and tails, left foot. The non-taped foot will be used as a control. The runner's normal sock/shoe system will be used to reflect natural wilderness conditions. Participants will have demographic data collected prior to the race, including age, gender, country of origin, number of marathons run prior, pack weight, and sock type. The study endpoint occurs when a hot spot or blister develops on either the treated or untreated foot. Runners will be instructed to treat suspected blisters or hot spots as they normally would, and to inform the study administrators the same day for visual inspection and final questionnaire to determine if they develop blisters or hot spots, whether they applied or re-applied tape themselves, removed tape, and the reasons for these actions.
Participants will have tape applied to area(s) prone to blister on 1 foot, if no blister history, 1 area will be randomly assigned. The tape will be left on the selected foot until a blister or hot spot develops on either foot or the end of the race, whichever comes first. At that point, the study is over and the participant can continue or stop taping at their choice. If participants are prone to blisters or hot spots in particular areas, 1" paper tape applied to that site on trial foot. However, if the participant has no previous blister or hot spot experience, a site will be randomly assigned by picking a piece of paper out of a bag with the site written on a piece of paper (heel, toe, instep, head of 5th metatarsal). Therefore, a single participant can have more than 1 site on an individual foot.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94034
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Any runner who are enrolled in an RTP 4 deserts event, All runners who are 18-75 years old All runners who speak or read English. The study will be enrolling only those who speak or read English, so they can fully understand and have knowledgeable consent to the study enrollment protocols.
Exclusion Criteria:
Any blisters, broken blisters, or hot spots present on either foot at the time of initial taping as determined by visual foot inspection by a enrolling researcher.
The runner allergic to paper-tape.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Paper Tape
Paper tape will be 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.
|
Applied to blister prone areas of the foot
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Count of Participants With Any Foot Blister in Taped or Untaped Area of the Foot
Time Frame: within 7 days of application of tape
|
Blister data were collected without regard to whether the foot was right or left.
|
within 7 days of application of tape
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28548
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Blister of Foot
-
Stanford UniversityRecruitingBlister of FootChile, Mongolia, Namibia
-
Institut de Formation et de Recherche en Médecine...RecruitingSport Injury | Blister of FootFrance
-
Institut de Formation et de Recherche en Médecine...RecruitingSport Injury | Blister of FootFrance
-
Muhammet Ayhan ORALCompletedDorsiflexion Deformity of FootTurkey
-
RTI SurgicalTerminatedFoot Deformities, Acquired | Fracture of Foot | Disorder of Joint of Foot | Deformity of BoneUnited States
-
Talita Cumi Ltd.Aetrex Worldwide IncCompleted
-
PolyOrth InternationalNot yet recruitingTesting of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism Criteria
-
Ochsner Health SystemUnknownStrain of Muscle and/or Tendon of Lower Leg | Fracture of Lower Leg | Crushing Injury of Lower Leg | Fracture Malunion - Ankle and/or Foot | Disorder of Joint of Ankle and/or Foot | Complete Tear, Ankle and/or Foot Ligament | Pathological Fracture - Ankle and/or Foot | Loose Body in Joint of Ankle...United States
-
Inion OyRecruitingFractures, Bone | Foot Deformities | Ankle Fractures | Hallux Valgus | Hallux Rigidus | Fracture of Foot | Lisfranc Fracture | Metatarsalgia | Lisfranc Injury | Deformity, Foot | Calcaneus Fracture | Talus Fracture | Medial Malleolus Fracture | Navicular Fracture | Foot Fracture | Foot Injury | Feet Deformity Tarsus | Deformity... and other conditionsFinland
-
University of MinnesotaTerminatedHallux Valgus | Instability of the Foot ArchUnited States
Clinical Trials on Paper Tape
-
Stanford UniversityUniversity of California, DavisCompleted
-
Kaohsiung Veterans General Hospital.Unknown
-
Georgetown UniversityCompletedCirrhosis, LiverUnited States
-
Yonsei UniversityCompletedBreast NeoplasmsKorea, Republic of
-
John Paul II University of Applied Sciences in...CompletedMuscle WeaknessPoland
-
University of Illinois at ChicagoTerminated
-
University Rovira i VirgiliCompleted
-
Taipei Medical University WanFang HospitalUnknownAnkle Sprains | TapingTaiwan
-
Johns Hopkins UniversityCompleted
-
Universidade Norte do ParanáCompletedChronic Ankle Instability | Ankle Sprains | Athletes FootBrazil