None listed
Conditions
Brief summary
Foot ulcers are a common consequence of diabetes due to the development of peripheral neuropathy, peripheral vascular disease, limited joint mobility and foot deformity. Nearly 34% of persons with diabetes will develop a foot ulcer in their lifetime. This can lead to infection and amputation. Diabetes is the main reason for non-traumatic amputation. Reducing plantar pressures is considered a key factor for wound healing and prevention of ulcer recurrence. Footwear and insoles are an important treatment modality for off-loading these pressures. There is no existing, evidence-based recommendation for overall footwear design with all technical specifications to off-load the neuropathic diabetic foot. Hence this study will explore the design and modification features of footwear and insole that can reduce risk of neuropathic plantar forefoot ulceration in people with diabetes.
Interventions
Each participant is required to commit to making him/herself available for the initial assessment and follow up appointments. This period can be between 10 to 12 weeks from the initial fitting. This is recommended based on common practice within the high-risk foot services and pedorthic services for offloading. Both the clinicians and participants can have a better understanding of the efficacy of offloading, walking comfort and aesthetics of the devices by this time period. Participants are als
Each participant is required to commit to making him/herself available for the initial assessment and follow up appointments. This period can be between 10 to 12 weeks from the initial fitting. This is recommended based on common practice within the high-risk foot services and pedorthic services for offloading. Both the clinicians and participants can have a better understanding of the efficacy of offloading, walking comfort and aesthetics of the devices by this time period. Participants are also required to select a preferred style of footwear and report on the activities for which they intend to wear the footwear. The footwear will properly accommodate the foot and the upper will be softer and seam-free, so there is no pressure or rubbing from the upper. The outsole will have appropriate rocker profile to adequately offload plantar pressure at the forefoot. The insole will have adequate contact with the plantar surface of the foot with the configuration of arch support, metatarsal dome or bar, Plastazote top cover, Poron mid-layer and EVA base. Participants need to wear footwear and insoles as directed by the researcher. The common recommendation is to wear the footwear for half-an-hour on the first day, an hour for the 2nd day and an hour increase on each day. After a week, the participants will be wearing the footwear and insole for 8 hours and increase the wearing period further if there is no rubbing, redness or discomfort. Then they will be instructed to wear them most of the time they weight-bear. There will be an in-shoe sensor attached to the insoles to measure wearing period over the study periods. The participants will also undergo in-shoe plantar pressure measurements at each fitting and review appointments where they need to walk up to 12 meters at a self-selected pace that represents their regular pace of walking and consistent during each measurement. F-Scan sensors will be calibrated at “Walk” calibration and bodyweight of the participant will be recorded each time during the analysis.
Sponsors
Southern Cross University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be adults ( over 18 years of age) with type-1 or type-2 diabetes, peripheral neuropathy and recently healed plantar forefoot ulcer. Participants may have at least one or more forefoot deformities such as claw/hammer toes, cross over toes, hallux valgus, hallux amputation, limited joint mobility, pes planus or, pes cavus and bony prominences at metatarsal heads. Participants will have required referral for orthopedic footwear (either custom-made or prefabricated medical grade footwear with or without modification) and custom-made insoles, and have adequate English communication skills to provide informed consent and comprehend the study procedures.
Exclusion criteria
Exclusion criteria will be bilateral amputation (proximal to the trans-metatarsal joint), active or inactive Charcot foot, healed heel ulcers, midfoot deformities, use of walking aid for off-loading the foot, or severe illness, such that the participant may not survive for the study period.
Outcome results
None listed