Innovation of Custom-made Silicon Insoles for Diabetic Patient

NCT06654609 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/744
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

• The American Orthopedic - AO

  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

Study Arms (1)

Insoles for Foot

EXPERIMENTAL

Combination Product: Insoles for Foot

Interventions

Insoles for Foot 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.

Insoles for Foot

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Pakistan Rehablitation center Peshawar

Peshawar, Pakistan

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: November 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: November 30, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)