Blister Eradication Looking at Impact of Experimental Versus Established Regimens

NCT03835806 | Unknown

• 1 other identifier: IRB-49612
• Study Type: interventional
• Target: 130
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Blister of Foot

Outcome Measures

Primary Outcomes (1)

• 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. 1. The blister treatment is a success as defined by: 1. the blister treatment falls off and the subject has no pain and no blister reoccurrence 2. the blister treatment is removed by the subject and does not need to be replaced because the there is no pain or blister present 3. the blister treatment stays on for the length of the study needing no intervention 2. The blister treatment is a failure as defined by: 1. if the blister re-occurs 2. if the treated area has pain to the point that the blister treatment must be removed to evaluate 3. if the subject removes the blister treatment and needs to be retreated. 3. The race has come to completion 4. 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.

Study Arms (2)

Elastikon - traditional

ACTIVE COMPARATOR

The participant will be randomized to a treatment arm according to their racing bib number. Even bib numbers will be in the Elastikon treatment arm. The researcher will evaluate the blister and treat according to treatment arm with the following blister treatment device intervention: the blister will be prepped per routine, drained, covered with paper tape, sprayed with adhesive spray and then covered with Elastikon.

Other: Elastikon

Rocktape - novel

EXPERIMENTAL

The participant will be randomized to a treatment arm according to their racing bib number. Odd bib numbers will be in the Rocktape treatment arm. The researcher will evaluate the blister and treat according to treatment arm with the following blister treatment device intervention: the blister will be prepped per routine, drained, covered with paper tape and then covered with Rocktape

Other: Rocktape

Interventions

Elastikon OTHER

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.

Elastikon - traditional

Rocktape OTHER

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.

Rocktape - novel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Toe blisters will be excluded because they are treated with paper tape only to avoid friction against neighboring toes and further blister formation.
• Only intact blisters are included in this study as de-roofed blisters are treated differently.
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (3)

Racing the Planet

San Pedro de Atacama, Chile

RECRUITING

Racing the Planet

Ulaanbaatar, Mongolia

RECRUITING

Namib Desert

Windhoek, Namibia

RECRUITING

Study Officials

• Patrick B Burns, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick B Burns, MD

CONTACT

9788663533; pburns@stanford.edu

Grant Lipman, MD

CONTACT

4152909286; gslipman@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The treatments are visually dissimilar, therefore blinding for the investigator and subject is not possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: This is a randomized control trial looking at a novel blister treatment intervention versus a traditional model.

Study Record Dates

• First Submitted: February 2, 2019
• First Posted: February 11, 2019
• Study Start: April 27, 2019
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1); NA (1); CL (1)