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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87231372
Enrollment
130
Registered
2006-09-29
Start date
2006-03-03
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional, Metabolic, Endocrine: Diabetes Nutritional, Metabolic, Endocrine Diabetes

Interventions

The participants will be taken from both referrals and the existing caseload of the North and East Cornwall PCT Podiatry Service and Plymouth PCT podiatry service. Each participant will be required to

Sponsors

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Plantar peak pressure for the entire plantar surface during the stance phase of gait.

Secondary

MeasureTime frame
Added 29 July 2008: 1. Forefoot pressure time integral 2. Total contact area 3. Rate of forefoot loading 4. Duration of load as a percentage of stance 5. Perceived foot health 6. Quality of life 7. Cost

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026