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Design and manufacture of diabetic preventative shoes and its effect on skin biometric in people with diabetic neuropathy

Design and manufacture of diabetic preventative shoes and evaluating the effect of medium-term wear on skin biometric changes in people with diabetic neuropathy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220414054535N1
Enrollment
20
Registered
2022-06-22
Start date
2022-06-22
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: In this study, diabetic prevention shoes will be designed and manufactured based on prototyping from external diabetic prevention shoes. Features of this shoe incre

Sponsors

University of social welfare and rehabilitation sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age between 45-65 years Diagnosis of Diabetic Neuropathy by an Endocrinologist and Metabolism Based on the Michigan Neuropathy Screening Scale A history of type 2 diabetes for at least 5 years Pressure of more than 200 kPa on the head of the metatarsals Ability to walk and stand independently without assistive devices Ability to weight bearing and pressure on the foot Normal range of motion of ankle, knee and hip joints Normal Body Mass Index Fasting blood sugar above 125 HBA1C between 7 and 9 for at least 5 years Risk factor 1 based on IWGDF Employed people who work outside for at least 6 hours a day.

Exclusion criteria

Exclusion criteria: Having any deformity and wound on the plantar surface Having peripheral vascular disease (PVD) Have a history of surgery on the lower back and lower limbs during the last six months Presence of Charcot joint Spinal canal stenosis and severe radiculopathic pain

Design outcomes

Primary

MeasureTime frame
Skin thickness. Timepoint: Before intervention - 3 months after intervention. Method of measurement: skin scanner-DUB.

Secondary

MeasureTime frame
Skin density. Timepoint: Before intervention - 3 months after intervention. Method of measurement: skin scanner-DUB.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGholamreza Aminian

University of social welfare and rehabilitation sciences

gho.aminian@uswr.ac.ir+98 21 2218 0010

Outcome results

None listed

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