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Investigating the effect of 3 months using shoe with custom diabetic prevention insole on the biophysical characteristics of the skin of the foot of people with type 2 diabetic neuropathy

Investigating the effect of 3 months using shoe with custom diabetic prevention insole on the biophysical characteristics of the skin of the foot of people with type 2 diabetic neuropathy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220416054549N1
Enrollment
20
Registered
2022-06-08
Start date
2022-07-06
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

diabetes. Type 2 diabetes mellitus with diabetic neuropathy, unspecified

Interventions

Intervention 1: Intervention group: People in this group will receive diabetic prevention shoes with customized diabetic insoles and will use them for 3 months. The shoes will be made based on the siz

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age between 65-45 years Diagnosis of diabetic neuropathy by an endocrinologist based on the Michigan Neuropathy Screening Scale A history of type 2 diabetes for at least 5 years Pressure distribution of more than 200 kPa on the head of metatarsals Ability to walk and stand independently without aids Ability to withstand weight and pressure on the floor surface No pain in the soles of the feet Do not use diabetic shoes and insoles in the past year Have a normal BMI Fasting blood sugar above 125 HBA1C between 7 and 9 Risk factor one based on IWGDF classification Employees who work outside the home for at least 6 hours a day. Ordinary people's shoes are in the Oxford category

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Transepidermal water loss. Timepoint: Initially and 3 months after onset. Method of measurement: Multi Probe Adapter System MPA 10 (Tewameter probe).

Secondary

MeasureTime frame
Skin elasticity. Timepoint: Initially and 3 months after onset. Method of measurement: Cutometer MPA580.;Thickness of the hypodermis. Timepoint: Initially and 3 months after onset. Method of measurement: Skin scanner-DUB.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHassan Saeedi

Iran University of Medical Sciences

saeedi.h@iums.ac.ir+98 21 2222 2059

Outcome results

None listed

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