Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers

Chronic Venous Hypertension With Ulcer Clinical Trial

Official title:

Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04793074
• Other study ID #: EBRN080321
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Egyptian Biomedical Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chronic venous ulcers.

Exclusion Criteria:

• Associated infection and associated ulcers of other etiologies.

Related Conditions & MeSH terms

• Chronic Venous Hypertension With Ulcer
• Ulcer
• Varicose Ulcer

Intervention

Combination Product:
• Transforming nanoparticle dressing
Transforming nanoparticle dressing
• Conventional compression dressing
Conventional compression dressing

Locations

Country	Name	City	State
Egypt	Helwan University	Helwan

Sponsors (1)

Lead Sponsor	Collaborator
Egyptian Biomedical Research Network

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete healing (weeks)	The primary end-point in the present study is the time to complete healing of ulcers	16 weeks