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New treatment option for Venous Leg Ulcer
Official title RCT Exudate Management Cutimed Sorbion Product Range
ClinicalTrials.gov ID: NCT06300762
What this study is testing
- What it's testing
- The fluid handling capacity of superabsorbent dressings varies depending on the design and construction. The use of effective advanced wound dressings is a promising strategy to achieve adequate absorption of wound exudate and malodour promoting wound healing.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrolment
- Participant is mentally and physically able to participate in this study
- Men, women, diverse ≥ 18 years
- Participant complies with study visit schedule
- Participant agrees to comply with all standard therapies (e.g., with regards to compression therapy)
You likely can't join if
- Participant already participates in this study with one ulcer (only one ulcer per participant is allowed)
- Participant is expected not to be willing or able to follow the study outlines and requirements
- Participant suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS
- Participant is undergoing an immuno-compromising therapy, such as systemic antineoplastic drugs and/or systemic corticosteroids
- Participant uses any medication that could potentially delay the wound healing ability
- Participant is an employee (staff or student) of the hospital site (institute) or the sponsor or is in a dependent relationship with a member of site...
See the full eligibility criteria
- Participant is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrolment
- Participant is mentally and physically able to participate in this study
- Men, women, diverse ≥ 18 years
- Participant complies with study visit schedule
- Participant agrees to comply with all standard therapies (e.g., with regards to compression therapy)
- Participant suffers from lower leg ulcer\ (including the ankle but not the feet) indicated to be treated with the study deviceinvestigational devices, requiring compression and fulfilling the following:
- Ulcer is not younger than 4 weeks and not older than 1 year
- Ulcer is ranging between 2 cm2 and 800 cm2
- One side of the ulcer is not extending 40 cm
- Depth of ulcer \< 2 cm
- Ankle-brachial pressure index (ABPI) of \>0.8 and ≤1.3, measurement not older than 12 months \ Participants with more than one ulcer are eligible for inclusion, however only one ulcer per patient will be included in the...
- Participant already participates in this study with one ulcer (only one ulcer per participant is allowed)
- Participant is expected not to be willing or able to follow the study outlines and requirements
- Participant suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS
- Participant is undergoing an immuno-compromising therapy, such as systemic antineoplastic drugs and/or systemic corticosteroids
- Participant uses any medication that could potentially delay the wound healing ability
- Participant is an employee (staff or student) of the hospital site (institute) or the sponsor or is in a dependent relationship with a member of site or sponsor staff, e.g. child, spouse etc.
- Participant is pregnant or currently breastfeeding
- Participant reporting (and/or suspected by investigator) addiction from alcohol or drugs or is substituted e.g., by Methadone 8\. Participant suffers from alcohol or drug addiction or is substituted e.g., by Methadone...
The study team makes the final eligibility decision.
Where it's taking place
- Melle, Niedersachsten, Germany
- Wakefield, West Yorkshire, United Kingdom
- Ashington, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melle, Niedersachsten, Germany; Wakefield, West Yorkshire, United Kingdom; Ashington, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.