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Clinical Trials/NCT06654609
NCT06654609
Active, not recruiting
Not Applicable

Innovation of Custom-made Silicon Insoles for Diabetic Patient

Superior University1 site in 1 country4 target enrollmentNovember 1, 2023
ConditionsDiabetic Foot

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Foot
Sponsor
Superior University
Enrollment
4
Locations
1
Primary Endpoint
The American Orthopedic - AO
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
November 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Muhammad Naveed Babur

Principal Investigator

Superior University

Eligibility Criteria

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

Outcomes

Primary Outcomes

The American Orthopedic - AO

Time Frame: 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.

Study Sites (1)

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