EDX110 - Efficacy and Safety in the Management of Hard-to-heal Wounds

Post-market study to determine the efficacy of EDX110 dressing system in hard-to-heal wounds.

Prospective, single-center, non-blinded, non-randomized, post-market study to determine the efficacy of EDX110 dressing system in diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).

Eligibility Criteria:
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 cells/mm3
* Albumin level of more than 3.5 g/dL
* Subject can ambulate at home or in the clinic with or without mobility aids
* BMI ≤45

Exclusion Criteria:

* Subjects with wounds that have any of the following characteristics:

  • Wounds that penetrate down to tendon, ligament, joint capsule or bone, underlying muscle tissue, or organs
* Tunnelling wounds

  * Known or suspected local skin malignancy at the site of the ulcer
  * DFU: Major structural abnormalities of the foot
  * DFU: Active Charcot deformity
  * VLU: inability to tolerate elastocompression (40 mm/hg)
  * Wound duration \>1 year
* Subjects receiving any of the following prior therapies:

  * In the last 10 days:

    * Chemical debridement
    * Dakin's solution
    * Medical honey therapy
  * In the last 30 days (or anticipated to require such medications during the study period):

    * Cytotoxic chemotherapy
    * Application of topical steroids to the ulcer surface
    * Use of ≥14 days of immune suppressants (including systemic corticosteroids) OR
    * Subject is anticipated to require such medications during the study period
  * In the last 30 days:

    o Study ulcer treatment with any advanced therapy, including, biomedical or topical growth factors, tissue engineered materials
  * In the last 6 months:

    * Any amputation to the affected leg
    * Revascularization (surgical or stenting) to the affected leg
* Known hypersensitivity to constituents of the product
* Osteomyelitis/bone infection of the affected foot/leg, as verified by x-ray within 30 days prior to screening
* Active cellulitis at the wound site
* History of radiation at the ulcer site, regardless of duration
* Chronic kidney disease stage 4 or 5
* Immune system disorders, including SLE, AIDS or HIV
* Presence of any other pathology that would limit blood supply and compromise healing
* Revascularization procedure to increase blood flow in the target limb
* Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of, or compliance with the study
* Women of childbearing age (women aged \<55 years who have not undergone menopause) who are:

  * Pregnant at time of enrolment
  * Planning to become pregnant during the time of the study
  * Have been pregnant within the last 6 months
  * Breast-feeding
  * Unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence) during the time of the study
  * Concurrent enrolment in any other study