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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336514
Recruitment Status : Active, not recruiting
First Posted : April 7, 2020
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
The Michener Institute for Education at UHN
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE February 24, 2020
First Posted Date  ICMJE April 7, 2020
Last Update Posted Date April 17, 2020
Actual Study Start Date  ICMJE March 6, 2020
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
  • 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)
  • 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.
  • 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
  • Sociodemographic data - job description [ Time Frame: 0 weeks ]
    Brief description of job demands
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Longitudinal Quantitative Assessment of the Effectiveness of Metatarsal Pads on Plantar Pressures
Official Title  ICMJE A Longitudinal Quantitative Assessment of the Effectiveness of Metatarsal Pads on Plantar Pressures
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Forefoot Callus
  • Podiatry
  • Foot Dermatoses
  • Keratosis
Intervention  ICMJE Device: 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.
Study Arms  ICMJE Experimental: Experimental Arm
Intervention: Device: Semi-compressed felt pad (SCF)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04336514
Other Study ID Numbers  ICMJE 18-5921
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE The Michener Institute for Education at UHN
Investigators  ICMJE
Principal Investigator: Ann Russell, PhD The Michener Institute for Education at UHN
PRS Account University Health Network, Toronto
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP