Innovation of Custom-made Silicon Insoles for Diabetic Patient

October 22, 2024 updated by: Muhammad Naveed Babur, Superior University
"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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Peshawar, Pakistan
        • Pakistan Rehablitation center Peshawar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insoles for Foot
Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSRSW/Batch-Fall22/744

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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