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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Procedure: Hydrogel/nano silver-based dressing

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the percentage of a reduction rate of the diabetic foot ulcer after intervention	assess of diabetic foot ulcers size "sq mm"	3 Weeks

Collaborators and Investigators

• Sponsor: Magda Bayoumi

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Actual): April 3, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 3, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 3, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Diabetic foot ulcer
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: A12982019

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