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 range18 Years
SexALL
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…
What they're measuring
1
Effect of EDX110 in reducing the wound size of commonly occurring hard-to-heal wounds: DFUs and VLUs