A Study Comparing an Investigational Wound Gel With Standard Treatment for Mild to Moderate Diabetic Foot Ulcers

Ki vehet részt

• The subject has signed an IEC-approved study informed consent form
• The subject is male or female, at least 18 years of age at the date of screening
• The subject has a confirmed diagnosis of Type 1 or Type 2 diabetes mellitus
• The subject has a body mass index (BMI) of less than 40 kg/m2
• The subject has an index ulcer with visible margins, having an area of ≥ 0.5 and ≤ 10.0 cm2 when measured by the electronic measuring device at screening
• The index ulcer has been present for less than 12 months
• The index ulcer is located on the plantar surface, toe or interdigital, heel, lateral or medial surface of the foot
• The index ulcer does not extend beyond the subcutaneous tissue
• The subject has an ABI > 0.6 to < 1.3 or TcPO2 ≥ 40 mmHg on the dorsum of the affected foot, or a great toe pressure ≥ 50 mmHg on the affected foot. Duplex ultrasound of the lower limb arteries is an acceptable alternative test but must show a peak systolic velocity ratio of <2 for at least one of the posterior tibial, dorsalis pedis, and peroneal arteries
• The subject has peripheral neuropathy evidenced by a Semmes Weinstein monofilament test
• The subject is willing and able to return for all mandatory visits as defined in the protocol
• The subject is willing and able to follow the instructions of the Investigator

Ki nem vehet részt

• The subject has been on oral steroid > 7.5 mg daily for greater than seven (7) consecutive days in the 30 days before Screening
• The subject has been on parenteral corticosteroids, or any cytotoxic agents for seven consecutive days in the period of 30 days before Screening
• The subject's index ulcer is primarily located on the dorsal surface of the foot
• The target ulcer probes to bone or is complicated by osteomyelitis or abscess formation
• The subject has more than 2 ulcers on the index foot (if there are two ulcers, the larger will be chosen as the index ulcer for treatment)
• The index ulcer is exudating heavily (subjects may be re-screened after heavy exudation is resolved)
• The subject has an allergy to any component of the test article
• The index ulcer is over an acute Charcot deformity
• The subject has a glycated hemoglobin (HbA1c) level of > 8.0% (historical data may be used from within 6 months prior to screening)
• The subject has a contralateral major amputation of the lower extremity
• The subject is unable to sustain off-loading as defined by the protocol
• The subject is a member of a vulnerable population (e.g., prisoner, employee or family member of Sponsor or site staff, minor child, significant intellectual deficit)
• Per Investigator's discretion the subject is not appropriate for inclusion in the investigation
• Female patients who are pregnant or lactating