A 3 Day In-use Assessment of the Scholl Corn Foam Cushions on Pain Levels Associated With Heloma Durum.
NCT ID: NCT04695873
Last Updated: 2021-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2021-06-16
2021-10-11
Brief Summary
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Detailed Description
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After completion of the investigation, the Investigator will make an Assessment of Tolerance for each subject based on their pain scores (VAS), PPQ responses and AEs reported.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group
Foam Cushion, applied daily on Days 1, 2 and 3 of the investigation.
Corn Foam Cushion
An anatomically shaped foam pad with a central hole. The upper layer is made from a honeycomb of interconnecting cells, the external facing surface is smooth, the underside is coated with adhesive.
No Treatment Group
No treatment
No interventions assigned to this group
Interventions
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Corn Foam Cushion
An anatomically shaped foam pad with a central hole. The upper layer is made from a honeycomb of interconnecting cells, the external facing surface is smooth, the underside is coated with adhesive.
Eligibility Criteria
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Inclusion Criteria
2. Male or female participants aged: ≥ 18 and \<70 years.
3. Otherwise healthy individual suffering from a single painful Heloma Durum on the dorsal digital or the plantar weight bearing area of the foot (or feet) as assessed by the Investigator or suitable delegate.
4. A baseline VAS score of ≥20 units and ≤75 units when measured on a VAS of 0-100.
5. Able to attend the investigation centre on the predefined day(s).
6. Owns or has access to a device with internet connectivity and is willing to download an investigation application and participate in the collection of patient-reported data (criterion only applicable for the use of electronic patient reported outcomes (ePRO) diary).
7. Is willing and capable of adhering to the investigational requirements.
Exclusion Criteria
2. Individuals who have received any of the following treatment of their Heloma Durum:
1. Conservative treatments (e.g. cushioning) within the last 2 days
2. Chemical treatments (e.g. Salicylic Acid plaster) within the last 2 weeks
3. Physical treatments (e.g. Heloma Durum debridement, including home debridement) within the last 6 weeks
3. Participants who, in the opinion of the Principal Investigator, have any unhealed skin at or surrounding the Heloma Durum as a result of any treatments used by the individual.
4. Significant foot deformities or inflammation (e.g. bunions, heel spurs, gout etc.).
5. Concurrent participation in another interventional clinical study/investigation, or participation within 30 days before Day 1 of this investigation.
6. Active infections of the foot or skin of the foot.
7. Those who are pregnant, attempting to become pregnant, or believe they may be pregnant or have given birth within the last 6 months (self-reported).
8. Participants who regularly use painkillers for ongoing conditions.
9. Participants who have taken over-the-counter painkillers within the last 2 days prior to screening.
10. Participants who are taking/or have taken prescription painkillers in the last 2 weeks prior to screening.
11. Participants who are unwilling to wear the same footwear throughout the investigation (footwear is defined as structured and enclosed shoes or trainers with a method of closure e.g. laces and a heel of less than 3 cm. Consistent wearing of socks/tights should be maintained throughout the investigation) for the duration of the investigation.
12. Any individuals with diabetes or poor blood circulation.
13. Any other callosity that is not identified as a Heloma Durum by a healthcare professional (i.e. soft corn, neurovascular corn, seed corn, fibrous corns).
14. Any Heloma Durum where the surrounding skin is inflamed or broken.
15. Any other features identified within the screening process that in the opinion of the Investigator will impact the safety or wellbeing of the participant or affect the outcome of the investigation.
16. Participants who are employees at the site or are a partner or first-degree relative of the Investigator.
17. Participants who fail to satisfy the Investigator of fitness to participate for any other reason
18 Years
69 Years
ALL
No
Sponsors
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O4 Research
UNKNOWN
Reckitt Benckiser Healthcare (UK) Limited
INDUSTRY
Responsible Party
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Principal Investigators
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David Watterson
Role: PRINCIPAL_INVESTIGATOR
Moneeb Saddiq
Role: STUDY_DIRECTOR
Locations
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Podiatry Services, West Community Services
Galway, , Ireland
Countries
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References
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Becker BA, Childress MA. Common Foot Problems: Over-the-Counter Treatments and Home Care. Am Fam Physician. 2018 Sep 1;98(5):298-303.
Booth J, Mclnnes A. The aetiology and management of plantar callus formation. J Wound Care. 1997 Oct 2;6(9):427-430. doi: 10.12968/jowc.1997.6.9.427.
Burkhart CG. Skin disorders of the foot in active patients. Phys Sportsmed. 1999 Feb;27(2):88-101. doi: 10.3810/psm.1999.02.673.
Devlin NJ, Shah KK, Feng Y, Mulhern B, van Hout B. Valuing health-related quality of life: An EQ-5D-5L value set for England. Health Econ. 2018 Jan;27(1):7-22. doi: 10.1002/hec.3564. Epub 2017 Aug 22.
Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997 Nov;35(11):1095-108. doi: 10.1097/00005650-199711000-00002.
Hodgkin SE, Hoffmann TJ, Ramsey ML. Minimizing Corns and Calluses. Phys Sportsmed. 1990 Jun;18(6):87-91. doi: 10.1080/00913847.1990.11710068.
Menz HB, Zammit GV, Munteanu SE. Plantar pressures are higher under callused regions of the foot in older people. Clin Exp Dermatol. 2007 Jul;32(4):375-80. doi: 10.1111/j.1365-2230.2007.02421.x. Epub 2007 Apr 8.
Omura EF, Rye B. Dermatologic disorders of the foot. Clin Sports Med. 1994 Oct;13(4):825-41.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.
Silfverskiold JP. Common foot problems. Relieving the pain of bunions, keratoses, corns, and calluses. Postgrad Med. 1991 Apr;89(5):183-8. doi: 10.1080/00325481.1991.11700901.
Rinaldi, F. & Clemente, F., 1994. The importance of formulation of a plaster containing salicylic acid in treatment of corns. Foot, The, 4(4), pp. 186-190.
Grouios, 2004. Corns and calluses in athletes' feet: a cause for concern. Foot, The, 14(4), pp. 175-184.
Other Identifiers
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4101101
Identifier Type: -
Identifier Source: org_study_id