EDX110 - Efficacy and Safety in the Management of Hard-to-heal Wounds (NCT06640985) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
EDX110 - Efficacy and Safety in the Management of Hard-to-heal Wounds
Chile43 participantsStarted 2024-12-04
Plain-language summary
Post-market study to determine the efficacy of EDX110 dressing system in hard-to-heal wounds.
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:
* Subjects ≥18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study
* An index ulcer meeting the following characteristics:
* Diabetic foot ulcer (DFU): Wagner Grade 1: partial- or full-thickness (superficial)
* DFU: Located on the anatomical foot; defined as distal to the medial malleolus
* Venous leg ulcer (VLU): Partial or full thickness
* VLU: Located below the knee and above the ankle
* Presents with or without clinical signs of superficial infection
* Present for ≥4 weeks and \<52 weeks
* Wounds will be dry to moderately exudating
* Post-debridement wound area is ≥0.5 cm2 and ≤25 cm2
* If two or more ulcers are present, the index ulcer must additionally be:
* The ulcer with the largest wound area
* ≥3cm distance from any other ulcer on the affected limb
* DFU: type 1 or type 2 diabetes (confirmed by the subject's medical history)
* DFU: HgbA1c \<9% at screening
* GFR\>30 mL/min/1,73m2
* Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following results within the past 30:
* Dorsum transcutaneous oxygen test (TcPO2): \>30mmHg;
* Subject's Ankle-Brachial Index (ABI) by Doppler: ≥0.7 and ≤1.2;
* Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot. For Ankle-Brachial Pressure Index (ABPI): \>1.2, for Toe Brachial Index (TBI): \>0.5
* A total lymphocyte count of more than 1500…
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
Effect of EDX110 in reducing the wound size of commonly occurring hard-to-heal wounds: DFUs and VLUs