The goal of this clinical investigation is to evaluate if VES-0-D (an investigational wound gel) works to treat mild to moderate Diabetic Foot Ulcers. The main question it aims to answer is: How well does VES-0-D gel support wound healing, compared with a standard wound treatment?
Other questions that are the target of the investigation are:
* the evaluation of wound characteristics relevant to healing * the evaluation of side effects at the site of application
The investigation will compare the wound area reduction over the 8 week treatment for VES-0-D vs standard of care treated patients.
The investigation will also collect wound assessment scoring results over the entire study duration as well as safety data on VES-0-D.
Participants will:
Have VES-0-D or standard of care applied every 3-4 days for 8 weeks, either at home or in the clinic Visit the clinic once every week for checkups and assessments. Keep a diary of their applications and any symptoms they might experience
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'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 a contralateral major amputation of the lower extremity
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)
Parallel
VES-0-D wound gel
DeviceVES-0-D Gel is a non-invasive topical medical device intended to manage moisture levels at the surface of open wounds
Standard of Care (Investigator Choice)
DeviceStandard of care wound dressing will be chosen by the treating physician
Percent wound area reduction from baseline at the end of 8 weeks in VES-0-D Gel vs. Standard Care-treated subjects
Changes from baseline in the total score of the Bates-Jensen Wound Assessment Tool (BWAT) (Bates-Jensen 2019)
The Bates-Jensen Wound Assessment Tool (BWAT) uses a list of 13 questions to come up with a result between 13 and 60 points. Higher points reflect a worse outcome (degeneration of the wound).
Number and nature of treatment-emergent adverse events
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