A 3 Day In-use Assessment of the Scholl Corn Foam Cushions on Pain Levels Associated With Heloma Durum.
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|ClinicalTrials.gov Identifier: NCT04695873|
Recruitment Status : Not yet recruiting
First Posted : January 5, 2021
Last Update Posted : January 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heloma Durum||Device: Corn Foam Cushion||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||An open label, randomized parallel group, no treatment control investigation.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Experimental: Treatment Group
Foam Cushion, applied daily on Days 1, 2 and 3 of the investigation.
Device: 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 Intervention: No Treatment Group
- Overall pain relief [ Time Frame: Days 1-3 ]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.
- Immediate pain relief [ Time Frame: 25 minutes ]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.
- Specific Timepoint pain relief [ Time Frame: Days 1-3 ]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.
- Percentage of participants experiencing a 25% pain reduction [ Time Frame: Days 1-3 ]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.
- Consumer Acceptability [ Time Frame: Days 1-3 ]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).
- Safety and Tolerability [ Time Frame: Days 1-3 ]
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.
- Foot Health Improvement [ Time Frame: Days 1-3 ]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.
- Quality of Life Improvement [ Time Frame: Days 1-3 ]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.
- Impact of Heloma Durum on work productivity and activity [ Time Frame: Day 1 ]Assessment of work productivity and activity impairment assessed by the Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) PRO.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04695873
|Contact: Moneeb Saddiqemail@example.com|
|Contact: Nikki Coumifirstname.lastname@example.org|
|Podiatry Services, West Community Services|
|Galway, Ireland, H91N973|
|Contact: David Watterson, BSc, MSc, PGDip, PGCert email@example.com|
|Principal Investigator:||David Watterson|
|Study Director:||Moneeb Saddiq|