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Comparison of insoles prescribed for diabetic patients with and without pedobarograph data

Comparison of insoles prescribed for diabetic patients with and without pedobarograph data

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40423820
Enrollment
402
Registered
2007-05-22
Start date
2007-01-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Diabetes Nutritional, Metabolic, Endocrine Diabetes

Interventions

Currently patients are issued with a poron insole designed according to the clinical examination of the foot. Patients who fit the inclusion criteria will be given information regarding the study at t

Sponsors

Derby Hospitals NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Able to walk a minimum of five metres unaided 2. New referral to podiatry 3. Presenting with plantar callus at initial podiatry assessment 4. No previous insole treatment 5. Aged greater than 18 years old

Exclusion criteria

Exclusion criteria: 1. Unable to walk a minimum of five metres unaided 2. Current ulceration 3. Previous insole treatment 4. Non-diabetes related medical problems affecting the lower limbs 5. Lower limb amputation at any level 6. Unclear diabetes diagnosis 7. Congenital foot deformities 8. Charcot foot changes 9. Previous foot or ankle surgery

Design outcomes

Primary

MeasureTime frame
To evaluate whether custom made insoles for diabetic patients which are guided in design by the pedobarograph data are more effective in reducing skin damage/callus/ulceration than those assessed via current clinical practice.

Secondary

MeasureTime frame
To evaluate how neuropathy, ischaemia and deformity affect the outcome of using an insole.

Countries

United Kingdom

Outcome results

None listed

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