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Innovation of Custom-made Silicon Insoles for Diabetic Patient

Innovation of Custom-made Silicon Insoles for Diabetic Patient

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06654609
Enrollment
4
Registered
2024-10-23
Start date
2023-11-01
Completion date
2024-11-30
Last updated
2024-10-23

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

Conditions

Diabetic Foot

Brief summary

Diabetic foot ulcers, caused by diabetes-related nerve and blood vessel damage, can lead to amputations. Silicone insoles help prevent ulcers but are often expensive. Affordable, customized insoles are available, making prevention more accessible.

Detailed description

This research aims to create affordable, locally manufactured silicone insoles for diabetic foot ulcers, reducing costs and improving accessibility. six-month study at the Pakistan.

Interventions

COMBINATION_PRODUCTInsoles for Foot

Assess the condition of foot ulcers in patients, beginning with creating a cast of the affected foot. After the initial rectification, necessary modifications are made to prepare the rough insole. The size and fit of the insole are then carefully checked against the patient's foot. I use local silicone materials, secured with lady socks or stockinette to ensure the insole stays in place and provides durability.

Sponsors

Superior University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Adults aged patients, * Both genders will be included * Diagnosed with diabetic ulcers/diabetes * Reporting pain and mild ulcers on foot,

Exclusion criteria

* Recent history of foot injuries * Presence of other musculoskeletal conditions affecting the foot * Inflammatory conditions such as rheumatoid arthritis or gout * Neurological conditions affecting foot or leg functions

Design outcomes

Primary

MeasureTime frameDescription
The American Orthopedic - AO12 MonthsIt was The American Orthopedic - AO Handbook Musculoskeletal Outcome Measures and Instruments by Suk, Hanson, Norvell & Helfet, published by Thieme in 2005 identifies the FHSQ as the most scientifically valid foot and ankle measure gangrene etc.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026