Diabetic Foot Ulcer (DFU)
Conditions
Keywords
Diabetic Foot Ulcer, Diabetes
Brief summary
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
Interventions
DEVICEVES-0-D wound gel
VES-0-D Gel is a non-invasive topical medical device intended to manage moisture levels at the surface of open wounds
Standard of care wound dressing will be chosen by the treating physician
Sponsors
Flen Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject has signed an IEC-approved study informed consent form 2. The subject is male or female, at least 18 years of age at the date of screening 3. The subject has a confirmed diagnosis of Type 1 or Type 2 diabetes mellitus 4. The subject has a body mass index (BMI) of less than 40 kg/m2 5. 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 6. The index ulcer has been present for less than 12 months 7. The index ulcer is located on the plantar surface, toe or interdigital, heel, lateral or medial surface of the foot 8. The index ulcer does not extend beyond the subcutaneous tissue 9. 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. 10. The subject has peripheral neuropathy evidenced by a Semmes Weinstein monofilament test. 11. The subject is willing and able to return for all mandatory visits as defined in the protocol 12. The subject is willing and able to follow the instructions of the Investigator
Exclusion criteria
1. The subject's index ulcer is primarily located on the dorsal surface of the foot 2. The target ulcer probes to bone or is complicated by osteomyelitis or abscess formation 3. The subject has a contralateral major amputation of the lower extremity 4. 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) 5. The index ulcer is exudating heavily (subjects may be re-screened after heavy exudation is resolved) 6. The subject has a glycated hemoglobin (HbA1c) level of \> 8.0% (historical data may be used from within 6 months prior to screening) 7. The subject has been on oral steroid \> 7.5 mg daily for greater than seven (7) consecutive days in the 30 days before Screening 8. The subject has been on parenteral corticosteroids, or any cytotoxic agents for seven consecutive days in the period of 30 days before Screening 9. The subject is unable to sustain off-loading as defined by the protocol 10. The subject has an allergy to any component of the test article 11. The index ulcer is over an acute Charcot deformity 12. 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) 13. Per Investigator's discretion the subject is not appropriate for inclusion in the investigation 14. Female patients who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent wound area reduction from baseline at the end of 8 weeks in VES-0-D Gel vs. Standard Care-treated subjects | From enrollment to the end of treatment at 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in the total score of the Bates-Jensen Wound Assessment Tool (BWAT) (Bates-Jensen 2019) | From enrollment to the end of treatment at 8 weeks | 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 | From enrollment to the end of treatment at 8 weeks | — |
Countries
Belgium
Outcome results
None listed