search
Back to results

A Longitudinal Quantitative Assessment of the Effectiveness of Metatarsal Pads on Plantar Pressures

Primary Purpose

Forefoot Callus, Podiatry, Foot Dermatoses

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Semi-compressed felt pad (SCF)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Forefoot Callus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Michener Chiropody ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Arm

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Perceived pain
Self-reported levels of pain will be recorded using the Visual Analogue Scale (0-100)
Physical Activity
23 item questionnaire assessing the daily activity profiles of the participants.
Sociodemographic data- employment
Location of place of employment - at home or outside of home
Sociodemographic data - job description
Brief description of job demands
Daily physical activity- workday sitting time
Time spent sitting on a typical work day in hours
Daily physical activity- weekend sitting time
Time spent sitting on a typical weekend day in hours
Daily physical activity- work day standing time
Time spent standing on a typical work day in hours
Daily physical activity- weekend standing time
Time spent standing on a typical weekend day in hours
Daily physical activity- workday walking time
Time spent walking or running or climbing on a typical work day in hours
Daily physical activity- weekend walking time
Time spent walking or running or climbing on a typical weekend day in hours
Daily physical activity- workday time spent on feet
Category of time spent on feet in hours on a typical work day in hours
Daily physical activity- weekend time spent on feet
Category of time spent on feet in hours on a typical weekend day in hours
Daily physical activity- workday strain on feet
Category of foot strain experienced on a typical work day
Daily physical activity- weekend strain on feet
Category of foot strain experienced on a typical weekend day
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
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

Full Information

First Posted
February 24, 2020
Last Updated
April 26, 2021
Sponsor
University Health Network, Toronto
Collaborators
The Michener Institute for Education at UHN
search

1. Study Identification

Unique Protocol Identification Number
NCT04336514
Brief Title
A Longitudinal Quantitative Assessment of the Effectiveness of Metatarsal Pads on Plantar Pressures
Official Title
A Longitudinal Quantitative Assessment of the Effectiveness of Metatarsal Pads on Plantar Pressures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
The Michener Institute for Education at UHN

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Forefoot Callus, Podiatry, Foot Dermatoses, Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Semi-compressed felt pad (SCF)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Average Plantar Pressure 0-8 weeks
Description
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.
Time Frame
Change from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Perceived pain
Description
Self-reported levels of pain will be recorded using the Visual Analogue Scale (0-100)
Time Frame
0 (pre and post insertion of SCF), 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Title
Physical Activity
Description
23 item questionnaire assessing the daily activity profiles of the participants.
Time Frame
0 (pre and post insertion of SCF), 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Title
Sociodemographic data- employment
Description
Location of place of employment - at home or outside of home
Time Frame
0 (pre and post insertion of SCF), 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Title
Sociodemographic data - job description
Description
Brief description of job demands
Time Frame
0 weeks
Title
Daily physical activity- workday sitting time
Description
Time spent sitting on a typical work day in hours
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Title
Daily physical activity- weekend sitting time
Description
Time spent sitting on a typical weekend day in hours
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Title
Daily physical activity- work day standing time
Description
Time spent standing on a typical work day in hours
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Title
Daily physical activity- weekend standing time
Description
Time spent standing on a typical weekend day in hours
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Title
Daily physical activity- workday walking time
Description
Time spent walking or running or climbing on a typical work day in hours
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Title
Daily physical activity- weekend walking time
Description
Time spent walking or running or climbing on a typical weekend day in hours
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Title
Daily physical activity- workday time spent on feet
Description
Category of time spent on feet in hours on a typical work day in hours
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Title
Daily physical activity- weekend time spent on feet
Description
Category of time spent on feet in hours on a typical weekend day in hours
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Title
Daily physical activity- workday strain on feet
Description
Category of foot strain experienced on a typical work day
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Title
Daily physical activity- weekend strain on feet
Description
Category of foot strain experienced on a typical weekend day
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Title
Daily physical activity- time of wearing pad on a workday
Description
Category of time for which pad was worn on a typical work day in hours
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Title
Daily physical activity- time of wearing pad on a weekend day
Description
Category of time for which pad was worn on a typical weekend day in hours
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Russell, PhD
Phone
416-596-3101
Ext
3456
Email
arussell@michener.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Catharine M Gray, DCH
Phone
416-596-3101
Ext
3381
Email
cgray1@michener.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Russell, PhD
Organizational Affiliation
The Michener Institute for Education at UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michener Chiropody Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catharine m Gray
Phone
416-596-3101
Ext
3381
Email
cgray1@michener.ca
First Name & Middle Initial & Last Name & Degree
Meera Narenthiran, DCH
First Name & Middle Initial & Last Name & Degree
Gayatri Aravind, PhD
First Name & Middle Initial & Last Name & Degree
Emily MacLeod, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Longitudinal Quantitative Assessment of the Effectiveness of Metatarsal Pads on Plantar Pressures

We'll reach out to this number within 24 hrs