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).

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