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

Study Overview
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Brief Summary
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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.

Detailed Description
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The investigation design will include an enrolment and randomisation visit followed by an at home in-use period and a final follow up phone call. The enrolment visit will include confirmation of eligibility and collection of baseline data, including baseline pain scores using the Visual Analogue Scale (VAS), medical history, demographics, and baseline Patient Reported Outcomes (PRO) assessments. Baseline data collected will be assessed to confirm eligibility before randomisation, first product application (treatment group only), initial pain (VAS) Participant Perceived Questionnaires (PPQ) and PRO assessments. During the at home in-use period, those participants randomised to the treatment group will reapply the product daily, complete pain assessments using the VAS (morning and evening), PPQs and PROs (Day 3 evening only). For participants randomised to the no-treatment group, they will complete pain assessments using the VAS (morning and evening) and PROs (Day 3 evening). All participants will continuously record Adverse Events (AE) and changes to concomitant medication throughout this period. During the follow up phone call, the participants will be contacted to establish any further AEs and/or changes to concomitant medication, additionally any queries related to diary entries will be made during this phone call. Participants will not need to return to the site unless advised to do so by the Principal Investigator (PI) or delegate. 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.

Official Title
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An Open-label, Randomised, Parallel-group, No-treatment Control Investigation to Determine the Effect of the Scholl Corn Foam Cushions, on Pain Levels When Used on Heloma Durum (Hard Corns) on the Dorsal Digital (Top of the Toe) and the Plantar Weight Bearing Areas (Ball of Foot) of the Feet

Conditions
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Heloma Durum

Intervention / Treatment
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* Device: Corn Foam Cushion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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). Any Heloma Durum where the surrounding skin is inflamed or broken. 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. Participants who are employees at the site or are a partner or first-degree relative of the Investigator. Participants who fail to satisfy the Investigator of fitness to participate for any other reason

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An open label, randomized parallel group, no treatment control investigation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Foam Cushion, applied daily on Days 1, 2 and 3 of the investigation. | Device: Corn Foam Cushion<br>* 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.<br>|
| No Intervention: No Treatment Group<br>No treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate pain relief | Comparison of change from baseline pain assessments (VAS) 25 minutes after replacing footwear between the treatment and no treatment groups. The pain VAS will be presented on a 0-100 scale with 0 indicating no pain at all and 100 indicating worst pain imaginable. | 25 minutes | 
| Specific Timepoint pain relief | Comparison of change from baseline in pain (VAS) at Day 1 evening, Day 2 morning and evening, Day 3 morning and evening following use of the Scholl Corn Foam Cushion whilst wearing footwear, 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 | 
| Percentage of participants experiencing a 25% pain reduction | Comparison of the percentage of participants who achieve 25% pain reduction from their baseline pain score at each time point 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 | 
| Consumer Acceptability | Participant Perceived Questionnaires at 25 minutes (+/- 5 minutes) after reapplication of footwear on day 1 and on the evening of Day 3, whilst wearing footwear (treatment group only). | Days 1-3 | 
| Safety and Tolerability | Investigator Assessment of Tolerance for each participant in the treatment group only based on pain scores (VAS) and PPQ responses and AEs. Overall proportion of participants with Adverse Events / Adverse Device Effects (AEs/ADEs) i.e. the occurrence of one or more AEs/ADEs per participant. | Days 1-3 | 
| Foot Health Improvement | Comparison of change in overall foot health from Baseline to Day 3, as assessed by the Podiatry Health Questionnaire (PHQ) Patient Reported Outcome (PRO) between the treatment and no-treatment groups. | Days 1-3 | 
| Quality of Life Improvement | Comparison of change in overall quality of life from baseline to Day 3, as assessed by the EQ-5D-5L PRO between the treatment and no-treatment groups. | Days 1-3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VAS Pain Assessment, Symptomatic Pain Relief