A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the … (NCT05632250) | Clinical Trial Compass
CompletedNot Applicable
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Dressings in the Management of Indicated Chronic Wound Types.
United States95 participantsStarted 2023-04-10
Plain-language summary
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ dressings in the management of indicated chronic wound types.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18 years and over
* Patients able and willing to provide informed consent
* Patients with wounds with a duration of no less than 2 months and no more than 12 months
* Patients must be willing to complete the QoL (quality of life) questionnaires via a valid email address
* Patients with at least one, but no more than two of the same wound indications which would require dressing according to the stage of the wound:
* Chronic ulcers (Venous, arterial, mixed aetiology or diabetic foot ulcers)
* Pressure Injury Stage II or greater
* Patients must be willing to attend visits as per schedule in protocol
Exclusion Criteria:
* Patients with known allergies to any of the materials used in the dressing
* Patients with known malignant wounds
* Patients requiring any oxidising agents such as hydrogen peroxide or hypochlorite solutions
* Patients, who in the opinion of the Investigator, are considered as unsuitable for any other reason
* Patients with chronic conditions such as autoimmune disorders in an acute flare phase, which in the opinion of the investigator would directly impact wound healing, use of immunosuppressant medications may be allowed if they have been on a stable dose and regimen over the past three months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To measure efficacy of ConvaFoam dressings in the exudate management of chronic wounds.