Table 2 Inclusion/exclusion criteria
Inclusion criteria | |
○ Patient is between 18 and 80 years of age | |
○ Patients with type I or type II diabetes with a glycosylated hemoglobin (HbA1c) of ≤ 12%, obtained at enrollment or within 30 days prior to study enrollment | |
○ Patients who have a wound defined as diabetic foot ulcer present for ≥ 4 weeks | |
○ Foot ulcer Wagner grade I–II or ARMSTRONG grade I-A (superficial, non-infected, non-ischemic wound not involving the tendon, capsules, or bone) or II-A (non-infected, non-ischemic wound penetrating to tendon or capsule but not to the bone or joint) | |
○ Estimated foot ulcer surface area between ≥ 1 and ≤ 8 cm2 as measured at the day of randomization assessed using the eKARE imaging and measurement device | |
○ A patient with more than one diabetic foot ulcer may be included in the study but only one ulcer will be selected for the investigational treatment based on investigator judgment as far as the ulcer meets the inclusion criteria (the largest ulcer fitting the inclusion criteria will be selected as index ulcer) | |
○ Wound area has not changed by more than 30% between screening visit and randomization visit (at least 14 days) | |
○ Adequate arterial blood perfusion (ABI [ankle brachial index] between 0.7 and 1.3 [the highest ABI measured value will be used as a reference], or toe pressure > 50 mmHg, or tcPO2 > 40 mmHg) within the past 6 months | |
○ Patient must adhere to off-loading of the ulcer area (in mobile patients, adherence to off-loading footwear during the study is mandatory) | |
○ Patient is able to give written informed consent prior to study start and to comply with the study requirements | |
○ Women of childbearing potential agree using adequate birth control methods during the study | |
Exclusion criteria | |
○ History of anaphylaxis, known hypersensitivity to sodium alginate, propylene glycol, methylene blue, or chicken egg | |
○ Target ulcer is over a deformity (such as Charcot deformity) that interferes with off-loading based on investigator’s opinion | |
○ Index wound duration of > 52 weeks without intermittent healing | |
○ Clinical evidence of ulcer bed infection or patients requiring intravenous (IV) antibiotics to treat the index wound infection at time of randomization | |
○ Current evidence of osteomyelitis, cellulitis, or other evidence of infection including pus drainage from the wound site, or documented history of osteomyelitis at the target wound location during the 6 months preceding the screening visit | |
○ Major uncontrolled medical disorder(s) such as severe uncontrolled leg edema, concurrent medication, or other issues that render the patient unsuitable for participation in the study, including but not limited to comorbid condition with an estimated life expectancy of ≤ 12 months, hemoglobin A1c (Hba1c) > 12% at screening, patients on dialysis, patients with severe pulmonary (requiring home oxygen, uncontrolled COPD Gold III/ IV) or cardiovascular conditions (heart failure NYHA IV, uncontrolled hypertension systolic BP by repeated measurement > 180 mmHg) | |
○ Raynaud disease or any other severe peripheral microvascular disease, current diagnosis of vasculitis, or current diagnosis of claudication | |
○ Dermatologic comorbid disease, history of systemic lupus erythematosus with elevated anti-DNA antibody titers, Buerger’s disease (thromboangiitis obliterans) | |
○ Patient currently treated for an active malignant disease or prior diagnosis of an active malignant disease who is disease free for less than 1 year. Treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy, or gene therapy) within 3 months before the first administration of the investigational product or at any time during the study | |
○ Patient with a history of malignancy within the wound; history of radiation therapy to the wound region | |
○ Patients who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days or during the study | |
○ Patients who received oral or parenteral corticosteroids, immunosuppressants, or cytotoxic agents within 30 days preceding the first study drug administration, or plan to use these medications during the study period | |
○ Patients who are pregnant or breastfeeding | |
○ Mental condition rendering the patient (or the patient’s legally acceptable representative[s]) unable to understand the nature, scope, and possible consequences of the study | |
○ Patients who are incarcerated, including prisoners or patients compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness | |
○ Therapy with another investigational agent within 30 days of screening, or during the study | |
○ Patients who are considered by the investigator to have a significant disease, which can impact the study; patients who are considered not suitable for the study by the investigator | |
○ Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse), or relationship to the sponsor | |
Prohibited medication | |
○ Oral or parenteral corticosteroids of > 20 mg/week within the past 4 weeks before the screening and during the course of the study (intranasal or inhaled steroids for allergies/asthma or COPD are allowed) | |
○ Immunosuppressive or cytotoxic agents within 30 days preceding the first study drug administration and during the study period | |
○ Wound treatments with growth factors, dermal substitutes, or other topical biological therapies within the last 30 days of screening and during the study duration |