EDX110 - Efficacy and Safety in the Management of 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