NCT04793074

Brief Summary

The present randomized controlled study aims to evaluate the role of transforming nanoparticle dressing n management of chronic venous ulcers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 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

July 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

March 8, 2021

Last Update Submit

March 8, 2021

Conditions

Chronic Venous Hypertension With Ulcer

Outcome Measures

Primary Outcomes (1)

  • Time to complete healing (weeks)

    The primary end-point in the present study is the time to complete healing of ulcers

    16 weeks

Study Arms (2)

Transforming nanoparticle dressing

EXPERIMENTAL

Patients in the treatment group (n=30) had transforming nanoparticle dressing

Combination Product: Transforming nanoparticle dressing

Conventional compression dressing

ACTIVE COMPARATOR

The control group (n=30) received conventional compression dressing.

Combination Product: Conventional compression dressing

Interventions

Transforming nanoparticle dressingCOMBINATION_PRODUCT

Transforming nanoparticle dressing

Transforming nanoparticle dressing
Conventional compression dressingCOMBINATION_PRODUCT

Conventional compression dressing

Conventional compression dressing

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic venous ulcers.

You may not qualify if:

  • \- Associated infection and associated ulcers of other etiologies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helwan University

Helwan, Egypt

Location

Related Publications (1)

  • Mahmood BA, ElSayed EH, Abd Elghany SM, Elnaggar DF, Youssef HAA, Abdelmaksoud SM. A New Powder Dressing for Management of Chronic Venous Ulcers. Dermatol Surg. 2023 Jul 1;49(7):664-668. doi: 10.1097/DSS.0000000000003812. Epub 2023 Apr 25.

    PMID: 37134230DERIVED

Study Officials

  • Barakat Abdelreheem

    Helwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

July 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)