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

NCT ID: NCT04336514

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-06
• Study Completion Date: 2021-08-30

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.

Conditions

Forefoot Callus; Podiatry; Foot Dermatoses; Keratosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm

Group Type: EXPERIMENTAL

Semi-compressed felt pad (SCF)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Michener Institute for Education at UHN

UNKNOWN

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Russell, PhD

Role: PRINCIPAL_INVESTIGATOR

The Michener Institute for Education at UHN

Locations

Michener Chiropody Clinic

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ann Russell, PhD

Role: CONTACT

arussell@michener.ca

416-596-3101 ext. 3456

Catharine M Gray, DCH

Role: CONTACT

cgray1@michener.ca

416-596-3101 ext. 3381

Facility Contacts

Catharine m Gray

Role: primary

cgray1@michener.ca

416-596-3101 ext. 3381

Other Identifiers

18-5921

Identifier Type: -

Identifier Source: org_study_id