ACTRN12620000699965
Not yet recruiting
未知
Footwear and insole design parameters to prevent occurrence and recurrence of neuropathic plantar forefoot ulcers in patients with diabetes; - A series of N-of-1 trials.
ConditionsDiabetesHistory of plantar forefoot ulcersIncreased barefoot plantar pressure,NeuropathyForefoot deformityAt risk of plantar forefoot ulcersPartial amputationUnilateral trans-met amputationPeripheral arterial diseaseMetabolic and Endocrine - DiabetesCardiovascular - Other cardiovascular diseasesMusculoskeletal - Other muscular and skeletal disordersInjuries and Accidents - Other injuries and accidentsNeurological - Other neurological disordersSkin - Other skin conditions
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Southern Cross University
- Enrollment
- 21
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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