Footwear and insole design parameters to prevent occurrence and recurrence of neuropathic plantar forefoot ulcers in patients with diabetes; - A series of single participant trials.

Not Applicable

• Conditions: Diabetes; History of plantar forefoot ulcers; Increased barefoot plantar pressure,; Neuropathy; Forefoot deformity; At risk of plantar forefoot ulcers; Partial amputation; Unilateral trans-met amputation; Peripheral arterial disease; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12620000699965
• Lead Sponsor: Southern Cross University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-23
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified