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

Not Applicable

• Conditions: Forefoot Callus; Foot Dermatoses; Keratosis; Podiatry
• Interventions: Device: Semi-compressed felt pad (SCF)

• Registration Number: NCT04336514
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-24
• Study Start: 2020-03-06
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28
• Primary Completion: 2021-05-31
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Arm	Semi-compressed felt pad (SCF)	-

Primary Outcome Measures

Name	Time	Method
Change in Average Plantar Pressure 0-8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Sociodemographic data- employment	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
Sociodemographic data - job description	0 weeks	Brief description of job demands
Daily physical activity- weekend sitting time	0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks	Time spent sitting on a typical weekend day in hours
Daily physical activity- work day standing time	0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks	Time spent standing on a typical work day in hours
Daily physical activity- weekend walking time	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
Daily physical activity- time of wearing pad on a workday	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
Daily physical activity- time of wearing pad on a weekend day	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
Physical Activity	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.
Daily physical activity- workday time spent on feet	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
Daily physical activity- workday strain on feet	0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks	Category of foot strain experienced on a typical work day
Daily physical activity- weekend time spent on feet	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
Perceived pain	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)
Daily physical activity- workday sitting time	0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks	Time spent sitting on a typical work day in hours
Daily physical activity- weekend standing time	0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks	Time spent standing on a typical weekend day in hours
Daily physical activity- workday walking time	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
Daily physical activity- weekend strain on feet	0 weeks, 2 weeks, 4 weeks, 6 weeks, and 8 weeks	Category of foot strain experienced on a typical weekend day

Trial Locations

Locations (1)

Michener Chiropody Clinic; 🇨🇦 Toronto, Ontario, Canada