Forefoot CallusNCT04336514
A Longitudinal Quantitative Assessment of the Effectiveness of Metatarsal Pads on Plantar Pressures
A study testing Semi-compressed felt pad (SCF) in people with Forefoot Callus and Podiatry, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Musculoskeletal deformities of the foot and abnormal biomechanics can create areas of high pressure over bony prominences on the plantar aspect of the foot and often lead to the formation of calluses and corns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Forefoot Callus, Podiatry, Foot Dermatoses
- What is being tested?
- Semi-compressed felt pad (SCF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 6 Mar 2020to 30 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants to be studied are from the general population with callus on the plantar aspect of the forefoot. The participants must have appropriate footwear with adequate space for pads and must be agreeable to wearing them majority of the study period for weight bearing activities. Participants must be willing to attend clinic every two weeks for 8 weeks
Who cannot join
- Participants with an active or past history of foot ulcers, those with Charcot neuroarthropathy as well as those who were unable to walk unaided will be excluded from the study. All participants will undergo a neuropathic assessment, including the vibration using a 127Hz tuning fork, protective sensation using a 10 gram monofilament and proprioception to exclude patients with neuropathy. Participants will be excluded if they have any foot skin disorders such as infections, dermatitis and psoriasis. Furthermore, anyone with neuropathy or diabetes for over 5 years will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Michener Chiropody Clinic
Toronto, Ontario, M5T 1V4
Catharine m Gray, 416-596-3101 ext. 3381, cgray1@michener.ca
Meera Narenthiran, DCH
About this study
Musculoskeletal deformities of the foot and abnormal biomechanics can create areas of high pressure over bony prominences on the plantar aspect of the foot and often lead to the formation of calluses and corns. Calluses and corns are reported to be the most prevalent foot conditions affecting peoples' lifestyles due to pain and disability. Redistribution of plantar pressure away from areas of high pressure offloading using felt pads to treat corns and calluses is a common practice in chiropody. A more comprehensive understanding of how rapidly the felt pads compress and become less effective in offloading pressure is needed to design better treatment plans to manage calluses and corns and improve patients' quality of life. The objectives of this study are: 1) develop a guideline which informs, at what duration (number of weeks) the semi compressed felt (SCF) Plantar Metatarsal Pad (PMP) should be replaced to manage plantar forefoot callus; 2) Test the guideline by replacing the SCF padding at the determined time interval. The study will be conducted at the Michener Chiropody Clinic at the Michener Institute of Education at UHN. In order to address patient selection bias, the investigators will be recruiting the first 25-40 participants presenting with forefoot callus who meet the inclusion criteria and consent to participate in the study. An exploratory, descriptive and analytic repeated measures study design will be used to address our research questions. The descriptive approach will provide insight into the nature of change over time in the dependent variables, pain and pressure, and an analytic approach will enable further insight into the relationship between those variables. The quantitative metrics used are average plantar pressure at the callus site, as well as self-reported pain using a Visual-Analog Scale (VAS). Results from the first phase will inform the development of the guideline for pad replacement, which in turn will be tested in the next phase of the study.
- Conditions
- Forefoot Callus, Podiatry, Foot Dermatoses, Keratosis
- Being tested
- Semi-compressed felt pad (SCF)
- Medical subject headings
- Foot Dermatoses, Keratosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-compressed felt pad (SCF)Device
Participants with forefoot callus will receive routine treatment of debridement of callus. Along with the debridement, a Plantar Metatarsal Pad (PMP) made of Semi-Compressed Felt (SCF) with appropriate cut outs will be placed in their shoes. The thickness of the SCF would be selected based on the patient weight, and appropriateness of the thickness would be confirmed by the Medilogic pressure measurement. A 50% pressure reduction is the desired outcome.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Device: Semi-compressed felt pad (SCF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Plantar Pressure 0-8 weeks
The change in the average value of plantar pressure identified during the gait cycle from baseline to 8 weeks after the application of the semi-compressed felt pad.
Measured: Change from baseline to 8 weeks
Secondary outcomes (16)
Perceived pain
Self-reported levels of pain will be recorded using the Visual Analogue Scale (0-100)
Measured: 0 (pre and post insertion of SCF), 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Physical Activity
23 item questionnaire assessing the daily activity profiles of the participants.
Measured: 0 (pre and post insertion of SCF), 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Sociodemographic data- employment
Location of place of employment - at home or outside of home
Measured: 0 (pre and post insertion of SCF), 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Sociodemographic data - job description
Brief description of job demands
Measured: 0 weeks
Daily physical activity- workday sitting time
Time spent sitting on a typical work day in hours
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- weekend sitting time
Time spent sitting on a typical weekend day in hours
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- work day standing time
Time spent standing on a typical work day in hours
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- weekend standing time
Time spent standing on a typical weekend day in hours
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- workday walking time
Time spent walking or running or climbing on a typical work day in hours
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- weekend walking time
Time spent walking or running or climbing on a typical weekend day in hours
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- workday time spent on feet
Category of time spent on feet in hours on a typical work day in hours
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- weekend time spent on feet
Category of time spent on feet in hours on a typical weekend day in hours
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- workday strain on feet
Category of foot strain experienced on a typical work day
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- weekend strain on feet
Category of foot strain experienced on a typical weekend day
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- time of wearing pad on a workday
Category of time for which pad was worn on a typical work day in hours
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- time of wearing pad on a weekend day
Category of time for which pad was worn on a typical weekend day in hours
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start6 Mar 2020
- Primary completion31 May 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forefoot CallusStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Michener Institute for Education at UHN
- Responsible party
- Sponsor
- Investigators
- Ann Russell, PhD, Principal investigator, The Michener Institute for Education at UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336514
- Sponsor's protocol ID
- 18-5921
- Status last verified
- Apr 2021
- First submitted
- 24 Feb 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Quantitative Assessment of the Effectiveness of Metatarsal Pads on Plantar Pressures
- ClinicalTrials.gov ID
- NCT04336514
- Acronym / sponsor ID
- 18-5921
- Conditions
- Forefoot Callus, Podiatry, Foot Dermatoses, Keratosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- The Michener Institute for Education at UHN
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 7 Apr 2020 (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.
Musculoskeletal deformities of the foot and abnormal biomechanics can create areas of high pressure over bony prominences on the plantar aspect of the foot and often lead to the formation of calluses and corns. Calluses and corns are reported to be the most prevalent foot conditions affecting peoples' lifestyles due to pain and disability. Redistribution of plantar pressure away from areas of high pressure offloading using felt pads to treat corns and calluses is a common practice in chiropody. A more comprehensive understanding of how rapidly the felt pads compress and become less effective in offloading pressure is needed to design better treatment plans to manage calluses and corns and improve patients' quality of life. The objectives of this study are: 1) develop a guideline which informs, at what duration (number of weeks) the semi compressed felt (SCF) Plantar Metatarsal Pad (PMP) should be replaced to manage plantar forefoot callus; 2) Test the guideline by replacing the SCF padding at the determined time interval. The study will be conducted at the Michener Chiropody Clinic at the Michener Institute of Education at UHN. In order to address patient selection bias, the investigators will be recruiting the first 25-40 participants presenting with forefoot callus who meet the inclusion criteria and consent to participate in the study. An exploratory, descriptive and analytic repeated measures study design will be used to address our research questions. The descriptive approach will provide insight into the nature of change over time in the dependent variables, pain and pressure, and an analytic approach will enable further insight into the relationship between those variables. The quantitative metrics used are average plantar pressure at the callus site, as well as self-reported pain using a Visual-Analog Scale (VAS). Results from the first phase will inform the development of the guideline for pad replacement, which in turn will be tested in the next phase of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: Semi-compressed felt pad (SCF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The participants to be studied are from the general population with callus on the plantar aspect of the forefoot. The participants must have appropriate footwear with adequate space for pads and must be agreeable to wearing them majority of the study period for weight bearing activities. Participants must be willing to attend clinic every two weeks for 8 weeks
Key exclusion criteria (1 listed)
- Participants with an active or past history of foot ulcers, those with Charcot neuroarthropathy as well as those who were unable to walk unaided will be excluded from the study. All participants will undergo a neuropathic assessment, including the vibration using a 127Hz tuning fork, protective sensation using a 10 gram monofilament and proprioception to exclude patients with neuropathy. Participants will be excluded if they have any foot skin disorders such as infections, dermatitis and psoriasis. Furthermore, anyone with neuropathy or diabetes for over 5 years will be excluded from the study.
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 |
|---|---|---|
| Semi-compressed felt pad (SCF)Participants with forefoot callus will receive routine treatment of debridement of callus. Along with the debridement, a Plantar Metatarsal Pad (PMP) made of Semi-Compressed Felt (SCF) with appropriate cut outs will be placed in their shoes. The thickness of the SCF would be selected based on the patient weight, and appropriateness of the thickness would be confirmed by the Medilogic pressure measurement. A 50% pressure reduction is the desired outcome. | Device | Experimental Arm |
Primary outcome
Change in Average Plantar Pressure 0-8 weeks
Time frame: Change from baseline to 8 weeks
The change in the average value of plantar pressure identified during the gait cycle from baseline to 8 weeks after the application of the semi-compressed felt pad.
16 secondary outcomes
Perceived pain
Time frame: 0 (pre and post insertion of SCF), 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Physical Activity
Time frame: 0 (pre and post insertion of SCF), 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Sociodemographic data- employment
Time frame: 0 (pre and post insertion of SCF), 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Sociodemographic data - job description
Time frame: 0 weeks
Daily physical activity- workday sitting time
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- weekend sitting time
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- work day standing time
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- weekend standing time
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- workday walking time
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- weekend walking time
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- workday time spent on feet
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- weekend time spent on feet
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- workday strain on feet
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- weekend strain on feet
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- time of wearing pad on a workday
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Daily physical activity- time of wearing pad on a weekend day
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- 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.
Ann Russell, PhD principal investigator
The Michener Institute for Education at UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-compressed felt pad (SCF) in people with Forefoot Callus and Podiatry, run by University Health Network, Toronto at 1 site in Canada.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Apr 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ann Russell, PhD (416-596-3101 ext. 3456, arussell@michener.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Average Plantar Pressure 0-8 weeks (time frame: Change from baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2021.