Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers
Primary Purpose
Chronic Venous Hypertension With Ulcer
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Transforming nanoparticle dressing
Conventional compression dressing
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Venous Hypertension With Ulcer
Eligibility Criteria
Inclusion Criteria:
- Chronic venous ulcers.
Exclusion Criteria:
- Associated infection and associated ulcers of other etiologies.
Sites / Locations
- Helwan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transforming nanoparticle dressing
Conventional compression dressing
Arm Description
Patients in the treatment group (n=30) had transforming nanoparticle dressing
The control group (n=30) received conventional compression dressing.
Outcomes
Primary Outcome Measures
Time to complete healing (weeks)
The primary end-point in the present study is the time to complete healing of ulcers
Secondary Outcome Measures
Full Information
NCT ID
NCT04793074
First Posted
March 8, 2021
Last Updated
March 8, 2021
Sponsor
Egyptian Biomedical Research Network
1. Study Identification
Unique Protocol Identification Number
NCT04793074
Brief Title
Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers
Official Title
Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egyptian Biomedical Research Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present randomized controlled study aims to evaluate the role of transforming nanoparticle dressing n management of chronic venous ulcers.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Hypertension With Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transforming nanoparticle dressing
Arm Type
Experimental
Arm Description
Patients in the treatment group (n=30) had transforming nanoparticle dressing
Arm Title
Conventional compression dressing
Arm Type
Active Comparator
Arm Description
The control group (n=30) received conventional compression dressing.
Intervention Type
Combination Product
Intervention Name(s)
Transforming nanoparticle dressing
Intervention Description
Transforming nanoparticle dressing
Intervention Type
Combination Product
Intervention Name(s)
Conventional compression dressing
Intervention Description
Conventional compression dressing
Primary Outcome Measure Information:
Title
Time to complete healing (weeks)
Description
The primary end-point in the present study is the time to complete healing of ulcers
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic venous ulcers.
Exclusion Criteria:
- Associated infection and associated ulcers of other etiologies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barakat Abdelreheem
Organizational Affiliation
Helwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helwan University
City
Helwan
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers
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