Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers

March 8, 2021 updated by: Egyptian Biomedical Research Network
The present randomized controlled study aims to evaluate the role of transforming nanoparticle dressing n management of chronic venous ulcers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present randomized controlled study was conducted at Helwan University Hospitals, Cairo, Egypt. The study protocol was approved by the local ethical committee and all patients gave informed consent before enrollment.

The study included 60 patients with CVU. Patients were diagnosed on the basis of clinical findings and vascular Doppler ultrasonography. Exclusion criteria were associated infection and associated ulcers of other etiologies. Patients randomization was achieved using computer generated numbers and sealed envelope technique. Randomization and patients' allocation to the study interventions was performed by an independent researcher who wasn't aware of the study interventions and outcome.

Upon recruitment, patients were subjected to careful history taking, thorough clinical examination, standard laboratory investigations and vascular ultrasound examination. The recorded parameters included demographic data (age, sex and body mass index), associated morbidities, duration and size of CVU and history of previous interventions.

After randomization, patients in the treatment group (n=30) had transforming nanoparticle dressing while the control group (n=30) received conventional compression dressing. Before applications of both dressings, the wound area was thoroughly cleaned. In the treatment group, the dressing powder was applied as a thin layer to the ulcer surface. Any excess powder surrounding the ulcer area was removed. In both groups, a secondary protective gauze dressing was applied. Patients were follow up at weekly intervals until complete healing occurs.

The primary end-point in the present study is the time to complete healing. The secondary end-point the rate of healing (percent of reduction in ulcer area).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Helwan, Egypt
        • Helwan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic venous ulcers.

Exclusion Criteria:

- Associated infection and associated ulcers of other etiologies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transforming nanoparticle dressing
Patients in the treatment group (n=30) had transforming nanoparticle dressing
Combination product: Transforming nanoparticle dressing
Transforming nanoparticle dressing
Active Comparator: Conventional compression dressing
The control group (n=30) received conventional compression dressing.
Combination product: Conventional compression dressing
Conventional compression dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to complete healing (weeks)
Time Frame: 16 weeks
The primary end-point in the present study is the time to complete healing of ulcers
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egyptian Biomedical Research Network

Investigators

  • Principal Investigator: Barakat Abdelreheem, Helwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBRN080321

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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