A 3 Day In-use Assessment of the Scholl Corn Foam Cushions on Pain Levels Associated With Heloma Durum.

NCT04695873 | Completed

• 1 other identifier: 4101101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-centre, parallel-group clinical investigation to evaluate the symptomatic pain relief, consumer acceptability and in-use tolerability of the Scholl Corn Foam Cushion in participants suffering from painful Heloma Durum over a 72-hour at home in-use period compared to a no-treatment control group.

Conditions

Heloma Durum

Keywords

VAS Pain Assessment; Symptomatic Pain Relief

Outcome Measures

Primary Outcomes (1)

• Overall pain relief

  Comparison of the average change from baseline in pain (VAS), across all timepoints from Day 1 to 3 between the treatment and no-treatment groups. The pain scores will be recorded on a pain visual analogue scale. which will be presented as a 0-100 scale with 0 indicating no pain at all and 100 indicating worst pain imaginable.

  Days 1-3

Secondary Outcomes (7)

• Immediate pain relief

  25 minutes

• Specific Timepoint pain relief

  Days 1-3

• Percentage of participants experiencing a 25% pain reduction

  Days 1-3

• Consumer Acceptability

  Days 1-3

• Safety and Tolerability

  Days 1-3

Other Outcomes (1)

• Impact of Heloma Durum on work productivity and activity

  Day 1

Study Arms (2)

Treatment Group

EXPERIMENTAL

Foam Cushion, applied daily on Days 1, 2 and 3 of the investigation.

Device: Corn Foam Cushion

No Treatment Group

NO INTERVENTION

No treatment

Interventions

Corn Foam Cushion DEVICE

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has provided written informed consent.
• Male or female participants aged: ≥ 18 and \<70 years.
• 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.
• A baseline VAS score of ≥20 units and ≤75 units when measured on a VAS of 0-100.
• Able to attend the investigation centre on the predefined day(s).
• 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).
• Is willing and capable of adhering to the investigational requirements.

You may not qualify if:

• Individuals who have known allergies or sensitivities to latex, or any other ingredients of the product, which in the opinion of the Investigator is considered clinically relevant.
• Individuals who have received any of the following treatment of their Heloma Durum:
• Conservative treatments (e.g. cushioning) within the last 2 days
• Chemical treatments (e.g. Salicylic Acid plaster) within the last 2 weeks
• Physical treatments (e.g. Heloma Durum debridement, including home debridement) within the last 6 weeks
• 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.
• Significant foot deformities or inflammation (e.g. bunions, heel spurs, gout etc.).
• Concurrent participation in another interventional clinical study/investigation, or participation within 30 days before Day 1 of this investigation.
• Active infections of the foot or skin of the foot.
• 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).
• Participants who regularly use painkillers for ongoing conditions.
• Participants who have taken over-the-counter painkillers within the last 2 days prior to screening.
• Participants who are taking/or have taken prescription painkillers in the last 2 weeks prior to screening.
• 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.
• Any individuals with diabetes or poor blood circulation.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead
• O4 Research: collaborator

Study Sites (1)

Podiatry Services, West Community Services

Galway, H91N973, Ireland

Location

Related Publications (12)

• Becker BA, Childress MA. Common Foot Problems: Over-the-Counter Treatments and Home Care. Am Fam Physician. 2018 Sep 1;98(5):298-303.

  PMID: 30216025 BACKGROUND

• 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.

  PMID: 27937673 BACKGROUND

• 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.

  PMID: 20086699 BACKGROUND

• 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.

  PMID: 28833869 BACKGROUND

• Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997 Nov;35(11):1095-108. doi: 10.1097/00005650-199711000-00002.

  PMID: 9366889 BACKGROUND

• Hodgkin SE, Hoffmann TJ, Ramsey ML. Minimizing Corns and Calluses. Phys Sportsmed. 1990 Jun;18(6):87-91. doi: 10.1080/00913847.1990.11710068.

  PMID: 27452098 BACKGROUND

• 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.

  PMID: 17425648 BACKGROUND

• Omura EF, Rye B. Dermatologic disorders of the foot. Clin Sports Med. 1994 Oct;13(4):825-41.

  PMID: 7805109 BACKGROUND

• 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.

  PMID: 10146874 BACKGROUND

• 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.

  PMID: 1826149 BACKGROUND

• 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.

  BACKGROUND

• Grouios, 2004. Corns and calluses in athletes' feet: a cause for concern. Foot, The, 14(4), pp. 175-184.

  BACKGROUND

MeSH Terms

Conditions

Callosities

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Watterson

  PRINCIPAL INVESTIGATOR

• Moneeb Saddiq

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open label, randomized parallel group, no treatment control investigation.

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 5, 2021
• Study Start: June 16, 2021
• Primary Completion: October 11, 2021
• Study Completion: October 11, 2021
• Last Updated: December 27, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)