- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04336514
A Longitudinal Quantitative Assessment of the Effectiveness of Metatarsal Pads on Plantar Pressures
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ann Russell, PhD
- Phone Number: 3456 416-596-3101
- Email: arussell@michener.ca
Study Contact Backup
- Name: Catharine M Gray, DCH
- Phone Number: 3381 416-596-3101
- Email: cgray1@michener.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 1V4
- Recruiting
- Michener Chiropody Clinic
-
Contact:
- Catharine m Gray
- Phone Number: 3381 416-596-3101
- Email: cgray1@michener.ca
-
Sub-Investigator:
- Meera Narenthiran, DCH
-
Sub-Investigator:
- Gayatri Aravind, PhD
-
Sub-Investigator:
- Emily MacLeod, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Arm
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived pain
Time Frame: 0 (pre and post insertion of SCF), 2 weeks, 4 weeks, 6 weeks, and 8 weeks
|
Self-reported levels of pain will be recorded using the Visual Analogue Scale (0-100)
|
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
|
23 item questionnaire assessing the daily activity profiles of the participants.
|
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
|
Location of place of employment - at home or outside of home
|
0 (pre and post insertion of SCF), 2 weeks, 4 weeks, 6 weeks, and 8 weeks
|
Sociodemographic data - job description
Time Frame: 0 weeks
|
Brief description of job demands
|
0 weeks
|
Daily physical activity- workday sitting time
Time Frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
|
Time spent sitting on a typical work day in hours
|
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
|
Time spent sitting on a typical weekend day in hours
|
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
|
Time spent standing on a typical work day in hours
|
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
|
Time spent standing on a typical weekend day in hours
|
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
|
Time spent walking or running or climbing on a typical work day in hours
|
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
|
Time spent walking or running or climbing on a typical weekend day in hours
|
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
|
Category of time spent on feet in hours on a typical work day in hours
|
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
|
Category of time spent on feet in hours on a typical weekend day in hours
|
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
|
Category of foot strain experienced on a typical work day
|
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
|
Category of foot strain experienced on a typical weekend day
|
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
|
Category of time for which pad was worn on a typical work day in hours
|
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
|
Category of time for which pad was worn on a typical weekend day in hours
|
0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ann Russell, PhD, The Michener Institute for Education at UHN
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-5921
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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