Chronic Venous Hypertension With UlcerPhase 4NCT04793074
Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers
A Phase 4 study testing Transforming nanoparticle dressing and Conventional compression dressing in people with Chronic Venous Hypertension With Ulcer, run by Egyptian Biomedical Research Network at 1 site in Egypt.
Trial summary
The present randomized controlled study aims to evaluate the role of transforming nanoparticle dressing n management of chronic venous ulcers. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Chronic Venous Hypertension With Ulcer
- What is being tested?
- Transforming nanoparticle dressing and Conventional compression dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic venous ulcers.
Who cannot join
- Associated infection and associated ulcers of other etiologies.
Trial locations and contacts
1 site in 1 country.
About this study
The present randomized controlled study aims to evaluate the role of transforming nanoparticle dressing n management of chronic venous ulcers.
Read the 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).
- Conditions
- Chronic Venous Hypertension With Ulcer
- Being tested
- Transforming nanoparticle dressing, Conventional compression dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforming nanoparticle dressingCombination product
Transforming nanoparticle dressing
Conventional compression dressingCombination product
Conventional compression dressing
| Study group | Role | What they receive |
|---|---|---|
| Transforming nanoparticle dressing | Experimental | Patients in the treatment group (n=30) had transforming nanoparticle dressing Receives: Combination Product: Transforming nanoparticle dressing |
| Conventional compression dressing | Active comparator | The control group (n=30) received conventional compression dressing. Receives: Combination Product: Conventional compression dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete healing (weeks)
The primary end-point in the present study is the time to complete healing of ulcers
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Jul 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous Hypertension With UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Barakat Abdelreheem, Principal investigator, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793074
- Sponsor's protocol ID
- EBRN080321
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37134230
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers
- ClinicalTrials.gov ID
- NCT04793074
- Acronym / sponsor ID
- EBRN080321
- Conditions
- Chronic Venous Hypertension With Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transforming nanoparticle dressing | Experimental | Combination Product: Transforming nanoparticle dressingPatients in the treatment group (n=30) had transforming nanoparticle dressing |
| Conventional compression dressing | Active comparator | Combination Product: Conventional compression dressingThe control group (n=30) received conventional compression dressing. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic venous ulcers.
Key exclusion criteria (1 listed)
- Associated infection and associated ulcers of other etiologies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transforming nanoparticle dressingTransforming nanoparticle dressing | Combination product | Transforming nanoparticle dressing |
| Conventional compression dressingConventional compression dressing | Combination product | Conventional compression dressing |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Derived from this study: PubMed 37134230Mahmood 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.
- Individual participant dataSharing planned: No
Related trials for Chronic Venous Hypertension With Ulcer
RecruitingObservational study
Comorbidities Resolution After MGB Surgery and Change in Body Composition
Morbid Obesity, Type2diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barakat Abdelreheem principal investigator
Helwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transforming nanoparticle dressing and Conventional compression dressing in people with Chronic Venous Hypertension With Ulcer, run by Egyptian Biomedical Research Network at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete healing (weeks) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04793074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.