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Hydrogel Blister Patch Prototype Treatment for Foot Blisters on the Heel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT01088685
First received: March 16, 2010
Last updated: October 4, 2011
Last verified: October 2011

March 16, 2010
October 4, 2011
March 2010
November 2010   (final data collection date for primary outcome measure)
Investigator Assessment [ Time Frame: at subject's last visit, within 14 days of start ] [ Designated as safety issue: No ]
Global assessment of the product by the investigator at the subject's last visit.
Same as current
Complete list of historical versions of study NCT01088685 on ClinicalTrials.gov Archive Site
  • Subject Assessment [ Time Frame: at subject's last visit, within 14 days of start ] [ Designated as safety issue: No ]
    Global assessment of the product by the subject at the subject's last visit.
  • Time to Heal [ Time Frame: Baseline to subject's last visit, within 14 days of start ] [ Designated as safety issue: No ]
    Record of the time it took for the blister to heal within the 14-day study period.
Same as current
Not Provided
Not Provided
 
Hydrogel Blister Patch Prototype Treatment for Foot Blisters on the Heel
Feasibility Study to Evaluate the Safety and Performance of a Hydrogel Blister Patch Prototype for the Treatment of Foot Blisters

Study to evaluate the safety and performance of a new blister patch intended to treat blisters on the heel of the foot.

The study will require participation for up to 14 days of participation or less if the blister heals sooner, will recruit 100 subjects with fluid filled blisters on the heel of the foot that are intact and not broken. Some subjects will be asked to have their blisters photographed. All subjects will be required to have their blister unroofed (top layer of skin removed by the physician using sterile instruments). All subjects will receive study product, either test product or a marketed product.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Blister
  • Device: Experimental Blister Patch
    Experimental hydrogel blister patch to be applied as needed (at least every 2 days) consecutively until blister heals
    Other Name: No trade name available - not a marketed product
  • Device: Marketed Pflaster
    Foot Blister Patch to be applied as needed (at least every 2 days) until blister heals
    Other Name: Scholls Blasen Pflaster
  • Experimental: Experimental Blister Patch
    Experimental Hydrogel Blister patch
    Intervention: Device: Experimental Blister Patch
  • Active Comparator: Marketed Pflaster
    Scholls Blasen Pflaster
    Intervention: Device: Marketed Pflaster
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects, 18 years of age or older;
  • Individuals who are willing and able to provide informed consent
  • Female subjects of child bearing potential must have a negative urine pregnancy test prior to application of the study products;
  • Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 such as the ones listed below and agree to continue using this method during their participation in the study; Note that abstinence is not an approved method of birth control.

    • Postmenopausal or amenorrheic for one year
    • Surgically sterile (hysterectomy, tubal ligation, or oophorectomy)
    • Use of an effective method of birth control (e.g. prescription oral contraceptives, contraceptive implants or injections, intrauterine device, diaphragm, cervical cap or condoms with spermicide)
  • Individuals exhibit a blister on the heel that is determined by the investigator to be no more than 72 hours old and in stage 2
  • Subject is willing to have blister unroofed (top layer of blister removed) by the investigator
  • Subject is willing and able to follow the study directions, to participate in the study, and to return for all specified visits

Exclusion Criteria:

  • Pregnant, planning a pregnancy or actively nursing
  • Exhibits a foot blister on the heel that exceeds 1125mm2 or would otherwise not be covered by the hydrogel portion of the study product
  • Unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study
  • Individuals with autoimmune disorders including, but not limited to, lupus erythematosus, rheumatoid arthritis, or HIV/AIDS
  • Currently participating in or, within the past 30 days have participated in another clinical study using an investigational drug or device
  • Employees of the site, or friends/relatives of employees that would have access to study information
  • Diabetic, type I or type II
  • Treatment for any type of cancer within the last 2 years or history of skin cancer
  • Damaged skin in or around test sites, which include sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, acne, and disfiguration of the test site
  • History of clinically determined allergic reaction or irritation to any of the test product ingredients
  • History of or known allergy to iodine
  • Currently taking or expected to take any of the following during the course of the study: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbiturates, and phencyclidine
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01088685
UNKEDI0001
No
Johnson & Johnson Consumer and Personal Products Worldwide
Johnson & Johnson Consumer and Personal Products Worldwide
Not Provided
Study Director: Qing Li, PhD J&J Consumer and Personal Products Worldwide
Johnson & Johnson Consumer and Personal Products Worldwide
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP