Blister Eradication Looking at Impact of Experimental Versus Established Regimens

Blister of Foot Clinical Trial

— BELIEVER  

Official title:

Blister Eradication Looking at Impact of Experimental Versus Established Regimens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03835806
• Other study ID #: IRB-49612
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Blister
• Blister of Foot

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.