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NCT04834245 Clinical Trial

Evaluation of Diabetic Foot Wound Healing Using Hydrogel/Nano Silver-based Dressing vs. Traditional Dressing

Diabetes Mellitus Clinical Trial

Official title:
Evaluation of Diabetic Foot Wound Healing Using Hydrogel/Nano Silver-based Dressing vs. Traditional Dressing: A Prospective Randomized Control Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04834245
Other study ID # A12982019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 3, 2019
Est. completion date December 30, 2019

Study information
Verified date April 2021
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: The wound dressings perform a crucial role in the cutaneous wounds' management due to their ability to protect wounds and promote dermal and epidermal tissue regeneration. Objective: the aim of the present study to evaluate the effectiveness of using hydrogel/nano silver-based dressing vs. traditional dressing on diabetic foot wound healing. Approach: Sixty patients with type-2 diabetes hospitalized for diabetic foot wound treatment were recruited from selected Surgical departments at Kasr Al-Aini university hospital.

Description:

Data Collection: The patients of group-I wounds were cleaned using normal saline; then, the wounds were closed firmly with hyderogel\nano silver dressing. The dressing was changed every two days according to dressing manufacture instruction. When the dressing was opened after three days, the wound was assessed for granulation tissue, wound, and discharge size. The patients of group II wounds were dresses using a traditional method, cleaned by normal saline, use of betadine antiseptic; then they were secured with clean linen gauze. The dressing was changed once daily. The wound healing process of the two groups was then assessed for three consecutive weeks.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 30, 2019
Est. primary completion date April 3, 2019
Accepts healthy volunteers No
Gender All
Age group 35 Years to 55 Years
Eligibility Inclusion Criteria: Diabetes Type I and Type II patient with diabetic foot ulcer age ranged 35-55 years old Willing to participate Exclusion Criteria: unwilling to participate.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Hydrogel/nano silver-based dressing
compare the effectiveness of using hydrogel/nano silver-based dressing vs. traditional dressing on diabetic foot wound healing.

Locations
Country Name City State
Egypt Cairo University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Magda Bayoumi

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary the percentage of a reduction rate of the diabetic foot ulcer after intervention assess of diabetic foot ulcers size "sq mm" 3 Weeks
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