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

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ClinicalTrials.gov Identifier: NCT04834245
Recruitment Status : Completed
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Magda Bayoumi, Beni-Suef University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Procedure: Hydrogel/nano silver-based dressing Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Diabetic Foot Wound Healing Using Hydrogel/Nano Silver-based Dressing vs. Traditional Dressing: A Prospective Randomized Control Study
Actual Study Start Date : January 3, 2019
Actual Primary Completion Date : April 3, 2019
Actual Study Completion Date : December 30, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: hydrogel/nano silver-based dressing
hydrogel/nano silver-based dressing
 Procedure: Hydrogel/nano silver-based dressing
compare the effectiveness of using hydrogel/nano silver-based dressing vs. traditional dressing on diabetic foot wound healing.


Outcome Measures
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Primary Outcome Measures :
  1. the percentage of a reduction rate of the diabetic foot ulcer after intervention [ Time Frame: 3 Weeks ]
    assess of diabetic foot ulcers size "sq mm"


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04834245


Locations
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Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Magda Bayoumi
More Information
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Responsible Party: Magda Bayoumi, Lecturer, Beni-Suef University
ClinicalTrials.gov Identifier: NCT04834245    
Other Study ID Numbers: A12982019
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Magda Bayoumi, Beni-Suef University:
Diabetic foot ulcer
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
 Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies