Evaluation of Diabetic Foot Wound Healing Using Hydrogel/Nano Silver-based Dressing vs. Traditional Dressing
Primary Purpose
Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hydrogel/nano silver-based dressing
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus focused on measuring Diabetic foot ulcer
Eligibility Criteria
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.
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hydrogel/nano silver-based dressing
Arm Description
hydrogel/nano silver-based dressing
Outcomes
Primary Outcome Measures
the percentage of a reduction rate of the diabetic foot ulcer after intervention
assess of diabetic foot ulcers size "sq mm"
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04834245
Brief Title
Evaluation of Diabetic Foot Wound Healing Using Hydrogel/Nano Silver-based Dressing vs. Traditional Dressing
Official Title
Evaluation of Diabetic Foot Wound Healing Using Hydrogel/Nano Silver-based Dressing vs. Traditional Dressing: A Prospective Randomized Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Magda Bayoumi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Diabetic foot ulcer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hydrogel/nano silver-based dressing
Arm Type
Experimental
Arm Description
hydrogel/nano silver-based dressing
Intervention Type
Procedure
Intervention Name(s)
Hydrogel/nano silver-based dressing
Intervention Description
compare the effectiveness of using hydrogel/nano silver-based dressing vs. traditional dressing on diabetic foot wound healing.
Primary Outcome Measure Information:
Title
the percentage of a reduction rate of the diabetic foot ulcer after intervention
Description
assess of diabetic foot ulcers size "sq mm"
Time Frame
3 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Diabetic Foot Wound Healing Using Hydrogel/Nano Silver-based Dressing vs. Traditional Dressing
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