NCT04834245

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

April 1, 2021

Last Update Submit

April 3, 2021

Conditions

Diabetes Mellitus

Keywords

Diabetic foot ulcer

Outcome Measures

Primary Outcomes (1)

  • the percentage of a reduction rate of the diabetic foot ulcer after intervention

    assess of diabetic foot ulcers size "sq mm"

    3 Weeks

Study Arms (1)

hydrogel/nano silver-based dressing

EXPERIMENTAL

hydrogel/nano silver-based dressing

Procedure: Hydrogel/nano silver-based dressing

Interventions

Hydrogel/nano silver-based dressingPROCEDURE

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

hydrogel/nano silver-based dressing

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • unwilling to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetic Neuropathies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 8, 2021

Study Start

January 3, 2019

Primary Completion

April 3, 2019

Study Completion

December 30, 2019

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)