Innovation of Custom-made Silicon Insoles for Diabetic Patient

NCT ID: NCT06654609

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-11-30

Brief Summary

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"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

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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.

Conditions

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Diabetic Foot

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Insoles for Foot

Group Type EXPERIMENTAL

Insoles for Foot

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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Insoles 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Superior University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Naveed Babur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pakistan Rehablitation center Peshawar

Peshawar, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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MSRSW/Batch-Fall22/744

Identifier Type: -

Identifier Source: org_study_id

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