Heloma DurumNCT04695873
A 3 Day In-use Assessment of the Scholl Corn Foam Cushions on Pain Levels Associated With Heloma Durum.
A study testing Corn Foam Cushion in people with Heloma Durum, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Heloma Durum
- What is being tested?
- Corn Foam Cushion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteIreland
- Study dates
- 16 Jun 2021to 11 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Heloma Durum
- Being tested
- Corn Foam Cushion
- Keywords
- VAS Pain Assessment, Symptomatic Pain Relief
- Medical subject headings
- Callosities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corn Foam CushionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Foam Cushion, applied daily on Days 1, 2 and 3 of the investigation. Receives: Device: Corn Foam Cushion |
| No Treatment Group | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 1-3
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start16 Jun 2021
- Primary completion11 Oct 2021
- Study completion11 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Heloma DurumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open label, randomized parallel group, no treatment control investigation.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- O4 Research
- Responsible party
- Sponsor
- Investigators
- David Watterson, Principal investigatorMoneeb Saddiq, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695873
- Sponsor's protocol ID
- 4101101
- Status last verified
- Dec 2021
- First submitted
- 4 Jan 2021
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Becker BA, Childress MA. Common Foot Problems: Over-the-Counter Treatments and Home Care. Am Fam Physician. 2018 Sep 1;98(5):298-303.
PubMed 30216025Booth 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.
PubMed 27937673Burkhart CG. Skin disorders of the foot in active patients. Phys Sportsmed. 1999 Feb;27(2):88-101. doi: 10.3810/psm.1999.02.673.
PubMed 20086699Devlin 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.
PubMed 28833869Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997 Nov;35(11):1095-108. doi: 10.1097/00005650-199711000-00002.
PubMed 9366889Hodgkin SE, Hoffmann TJ, Ramsey ML. Minimizing Corns and Calluses. Phys Sportsmed. 1990 Jun;18(6):87-91. doi: 10.1080/00913847.1990.11710068.
PubMed 27452098Menz 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.
PubMed 17425648Omura EF, Rye B. Dermatologic disorders of the foot. Clin Sports Med. 1994 Oct;13(4):825-41.
PubMed 7805109Reilly 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.
PubMed 10146874Silfverskiold 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.
PubMed 1826149Rinaldi, 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04695873
- Acronym / sponsor ID
- 4101101
- Conditions
- Heloma Durum
- Keywords
- VAS Pain Assessment, Symptomatic Pain Relief
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- O4 Research
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open label, randomized parallel group, no treatment control investigation.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Corn Foam CushionFoam Cushion, applied daily on Days 1, 2 and 3 of the investigation. |
| No Treatment Group | No intervention | –No treatment |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (20 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corn Foam CushionAn 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. | Device | Treatment Group |
Primary outcome
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.
7 secondary outcomes
Immediate pain relief
Time frame: 25 minutes
Specific Timepoint pain relief
Time frame: Days 1-3
Percentage of participants experiencing a 25% pain reduction
Time frame: Days 1-3
Consumer Acceptability
Time frame: Days 1-3
Safety and Tolerability
Time frame: Days 1-3
Foot Health Improvement
Time frame: Days 1-3
Quality of Life Improvement
Time frame: Days 1-3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Background: PubMed 30216025Becker BA, Childress MA. Common Foot Problems: Over-the-Counter Treatments and Home Care. Am Fam Physician. 2018 Sep 1;98(5):298-303.
- Background: PubMed 27937673Booth 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.
- Background: PubMed 20086699Burkhart CG. Skin disorders of the foot in active patients. Phys Sportsmed. 1999 Feb;27(2):88-101. doi: 10.3810/psm.1999.02.673.
- Background: PubMed 28833869Devlin 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.
- Background: PubMed 9366889Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997 Nov;35(11):1095-108. doi: 10.1097/00005650-199711000-00002.
- Background: PubMed 27452098Hodgkin SE, Hoffmann TJ, Ramsey ML. Minimizing Corns and Calluses. Phys Sportsmed. 1990 Jun;18(6):87-91. doi: 10.1080/00913847.1990.11710068.
- Background: PubMed 17425648Menz 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.
- Background: PubMed 7805109Omura EF, Rye B. Dermatologic disorders of the foot. Clin Sports Med. 1994 Oct;13(4):825-41.
- Background: PubMed 10146874Reilly 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.
- Background: PubMed 1826149Silfverskiold 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.
- BackgroundRinaldi, 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.
- BackgroundGrouios, 2004. Corns and calluses in athletes' feet: a cause for concern. Foot, The, 14(4), pp. 175-184.
- Irish Pharmaceutical Healthcare Association \[IPHA\], 2013. Clinical Trial Compensation Guidelines.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Watterson principal investigator
Moneeb Saddiq study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corn Foam Cushion in people with Heloma Durum, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall pain relief (time frame: Days 1-3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04695873, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.