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CompletedNCT04834245Updated Apr 8, 2021

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

An interventional study of Hydrogel/nano silver-based dressing in Diabetes Mellitus, sponsored by Magda Bayoumi. Completed at 1 site in Egypt. Open to participants aged 35 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-04-08.

Sponsored by Magda Bayoumi · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jan 2019, registered Apr 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
35 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Diabetic foot ulcer
03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Magda Bayoumi is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Diabetes Type I and Type II patient with diabetic foot ulcer age ranged 35-55 years old Willing to participate

Exclusion criteria

Exclusion Criteria:

unwilling to participate.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    hydrogel/nano silver-based dressing

    hydrogel/nano silver-based dressing

    Procedure: Hydrogel/nano silver-based dressing

Interventions

  • ProcedureHydrogel/nano silver-based dressing

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

06

What researchers measure

Primary outcomes

  1. the percentage of a reduction rate of the diabetic foot ulcer after intervention

    assess of diabetic foot ulcers size "sq mm"

    Time frame: 3 Weeks

07

Study locations

1 site
  • Cairo University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04834245
Lead sponsor
Magda Bayoumi
Responsible party
Magda Bayoumi (Lecturer, Beni-Suef University) — Sponsor-investigator
First posted
Apr 8, 2021
Start date
Jan 3, 2019
Primary completion
Apr 3, 2019
Completion
Dec 30, 2019
Last update
Apr 8, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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