Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound Management (NCT07549737) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound Management
Poland80 participantsStarted 2024-07-17
Plain-language summary
The purpose of this single arm clinical study is to find out how well two Silicone superabsorbent polymer dressings, RespoSorb Silicone (also known as Zetuvit Plus Silicone) and RespoSorb Silicone Border (also known as Zetuvit Plus Silicone Border), work in treating long lasting wounds on the lower legs or feet. The main goal of the study is to see whether these dressings help reduce wound size over time.
The study also looks at whether the dressings improve the condition of the wound and the surrounding skin. In addition, patients are asked about their experience with the dressings, including whether they help reduce pain and how satisfied patients are with the treatment.
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:
* Patient is 18 years of age or older and has given formal written consent.
* Diagnosed with a chronic, exuding lower extremity wound of a single limb:
* Venous leg ulcer (VLU) or
* Diabetic Foot Ulcer (DFU).
* Target ulcer persists since min. 1 and max. 12 months prior to screening.
* An appropriate dressing size is available to be used according to the size of the target ulcer, the ulcer size shall be no longer than 10 cm in one dimension.
* Target ulcer is not clinically infected ( Clinically infected wound is defined as a wound that required the use of systemic antibiotics or topical antimicrobials ).
* Ankle-brachial pressure index (ABPI) is between 0.8 and 1.2 measured during the Screening or within 30 days prior to the Screening Visit. If ABPI is \>1.2 the Toe-Brachial Index (TBI) should be \>0.6.
* Presence of an ulcer extending through the full thickness of the skin but not down to muscle, tendon or bone.
* For VLU: Patient is suitable for and agrees to use compression therapy (PütterPro2 or PütterPro2 Lite) for the study duration and was using compression therapy before study inclusion.
* For VLU: Patient is able to walk in conjunction to compression therapy. Ankle mobility is fully mobile to limited mobile.
* For DFU: Patient is suitable and agrees to use offloading devises for the study duration.
* For DFU: Patient is able to walk in conjunction to offloading devices. Ankle mobility is fully mobile to limited mobile.
Exclusion Criteria:
…
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
Wound area reduction
Timeframe: Up to 6 weeks (maximum total treatment period), or until wound healing, withdrawal, or discontinuation, whichever occurs first