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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03835806
Other study ID # IRB-49612
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 27, 2019
Est. completion date August 31, 2022

Study information

Verified date June 2021
Source Stanford University
Contact Patrick B Burns, MD
Phone 9788663533
Email pburns@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The specific aim of this study is to evaluate whether RockTape has similar efficacy to Elastikon in the treatment of foot blisters in ultramarathon runners. Elastikon with paper tape and spray adhesive is a well-accepted means of blister treatment and has been used by medical staff at over 50 multi-stage ultramarathons around the world. RockTape is another commercially available product that has also been used by runners successfully to treat foot blisters. RockTape's adhesive qualities have a potential advantage over Elastikon, in that it does not require an additional adhesive substituting a level of complexity, weight, and cost for foot care. There have been no studies examining the efficacy of either agent for blister treatment. This randomized controlled trial will compare the traditional method of treating blisters with a multi-step approach of percutaneous drainage, paper tape, spray adhesive and then Elastikon to percutaneous drainage, paper tape and RockTape.


Description:

Friction foot blisters are one of the most common injuries encountered by hikers and runners(1) with incidence as high as 39% in marathoners(2). In adventure races it is the most commonly reported injury(3) and in expedition length ultramarathons, blisters account for nearly 74% of medical visits(4). While most blisters are of minor medical significance, they can impair concentration, decrease athletic performance, and can be potentially debilitating. The specific aim of this study is to evaluate whether RockTape has similar efficacy to Elastikon in the treatment of foot blisters in ultramarathon runners. Elastikon with paper tape and spray adhesive is a well-accepted means of blister treatment and has been used by medical staff at over 50 multi-stage ultramarathons around the world. RockTape is another commercially available product that has also been used by runners successfully to treat foot blisters. RockTape's adhesive qualities have a potential advantage over Elastikon, in that it does not require an additional adhesive substituting a level of complexity, weight, and cost for foot care. There have been no studies examining the efficacy of either agent for blister treatment. This randomized controlled trial will compare the traditional method of treating blisters with a multi-step approach of percutaneous drainage, paper tape, spray adhesive and then Elastikon to percutaneous drainage, paper tape and RockTape.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date August 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - The study enrollment period will run for approximately 7 days over 3 weeks throughout 2019 at Racing the Planet races in Namibia, Mongolia and Chile. All racers are potential subjects. Subjects will be enrolled when they present to the medical tent for the treatment of their first painful blister. The subject will be evaluated for exclusion criteria and the subject will be asked to select the most painful blister to be included in the study. All other blisters may be treated through traditional means and are not included in the study. Exclusion Criteria: - Blister exclusion criteria: 1. Toe blisters will be excluded because they are treated with paper tape only to avoid friction against neighboring toes and further blister formation. 2. Only intact blisters are included in this study as de-roofed blisters are treated differently. 3. Hemorrhagic blisters are excluded as they are often not amenable to percutaneous drainage given the increased risk in infection. If the most painful blister is a toe blister or a hemorrhagic blister, then the second most painful blister will be selected. If there is no second blister, the subject cannot be enrolled at this time.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Elastikon
This randomized controlled trial will compare the traditional method of treating blisters with a multi-step approach of percutaneous drainage, paper tape, spray adhesive and then Elastikon which is our traditional blister treatment approach.
Rocktape
This randomized controlled trial will compare the traditional method of treating blisters with a multi-step approach of percutaneous drainage, paper tape and then Rocktape which is our novel blister treatment approach.

Locations

Country Name City State
Chile Racing the Planet San Pedro de Atacama
Mongolia Racing the Planet Ulaan Baatar
Namibia Namib Desert Windhoek

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Countries where clinical trial is conducted

Chile,  Mongolia,  Namibia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment success The subject's involvement in the study will end in one of the following situations and the researcher will fill out the appropriate data sheet at the time of the subject's departure from the study.
The blister treatment is a success as defined by:
the blister treatment falls off and the subject has no pain and no blister reoccurrence
the blister treatment is removed by the subject and does not need to be replaced because the there is no pain or blister present
the blister treatment stays on for the length of the study needing no intervention
The blister treatment is a failure as defined by:
if the blister re-occurs
if the treated area has pain to the point that the blister treatment must be removed to evaluate
if the subject removes the blister treatment and needs to be retreated.
The race has come to completion
The subject withdraws from the race or the study.
Data will be collected during the 1 week ultramarathon in austere conditions until study completion, usually 3-5 days. This will be conducted over 3 separate races.
See also
  Status Clinical Trial Phase
Recruiting NCT05086640 - Evaluation of the Effectiveness of the Local Application of Lemon in the Prevention of Blisters in Ultra-trail Runners N/A
Completed NCT01945112 - Prevention Trial Assessing Paper-Tape in Endurance Distances II (Pre-TAPED II) N/A
Recruiting NCT05071651 - Epidemiological Characteristics and Prevention Methods of Blisters in Ultra-trail Runners