The clinical and cost effectiveness of footwear and orthotic therapy in the management of the neuropathic diabetic foot - a single blind randomised controlled trial

Completed

• Conditions: utritional, Metabolic, Endocrine: Diabetes; Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN87231372
• Lead Sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

1. The subject must be diagnosed as type I or II diabetic
2. The subject must be identified as neuropathic and at risk of ulceration
3. The subject must not currently be suffering from any lower limb vascular or neuropathic ulceration identified by scoring Grade 0 on the Wagner classification for foot ulcer
4. The subject must be ambulant. Must be able to walk a minimum of approximately 10 metres unaided
5. The subject must be willing to comply with the requirements of the study

Exclusion Criteria

1. Subjects with current ulceration or recently healed less than 6 months prior to enrolling onto the study (as the focus of the study is preventative ulcer management rather than treatment)
2. Subjects with severe fixed midfoot or rearfoot deformity ie Charcot joint (subjects would be unsuitable for prefabricated insoles and non-bespoke footwear)
3. Subjects with a history of bone and joint surgery of the lower limb including amputation (could lead to alteration in gait kinetics and may not be suitable for non bespoke insoles and footwear)
4. Subjects lacking the ability to comprehend simple instructions and comply with the study protocols and procedures (including those not able to read printed English)
5. Allied Health Professional students as they may be considered to have a dependant relationship with the investigator
6. Subjects diagnosed as neuropathic caused by pathology other than diabetes

Study & Design

• Study Type: Interventional
• Study Design: Not specified