Innovation of Custom-made Silicon Insoles for Diabetic Patient

Not Applicable

Active, not recruiting

• Conditions: Diabetic Foot

• Registration Number: NCT06654609
• Lead Sponsor: Superior University

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.

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-06-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-22
• Last Update Submitted: 2024-10-22
• Study First Posted: 2024-10-23
• Last Update Posted: 2024-10-23
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The American Orthopedic - AO	12 Months	It 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.

Trial Locations

Locations (1)

Pakistan Rehablitation center Peshawar; 🇵🇰 Peshawar, Pakistan