Diabetic Foot Ulcer
Conditions
Keywords
Diabetes, Chronic wound
Brief summary
The purpose of this study is to determine if topical application of a hydrogel that contains plant extracts will improve healing of diabetic foot ulcers when compared to treatment with a hydrogel alone.
Detailed description
This is a multi center, double-blind, randomized, placebo-controlled trial. A total of 80 patients will be randomized according to a 1: 1 randomization schedule. To participate in the trial, patients must have a current Diabetic Foot Ulcer (DFU) for between 60 days to 2 years at the screening visit. In the 2-week period between screening and baseline visit, the patient's DFU must not have healed by 30% or more, in wound area, while being treated with SWT twice a week during this screening period. During the treatment period of 4 weeks all patients will be examined on a weekly basis by the site staff. Treatment with SWT plus the study gel (IZN-6D4 Gel or placebo gel) (including any necessary debridement) will be administered at these weekly visits. In addition, the patient or caregiver will be trained to perform SWT plus the study treatment at home once midweek between visits.
Interventions
DRUGIZN-6D4 Gel
Standard wound therapy plus twice weekly topical application of hydrogel containing botanical extracts.
OTHERPlacebo hydrogel
Standard wound therapy plus twice weekly topical application of color-matched placebo hydrogel
Sponsors
Izun Pharma Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current diagnosis of diabetes mellitus type 1 or 2 * Foot ulcer Wagner grade 1 or 2 * Ulcer between 1 square cm and 8 square cm present for at least 60 days and not more than two years * HgbA1C less than 10% * Able to comply with all procedures
Exclusion criteria
* Wound area decrease of greater than 30% between screening and baseline visits * Gangrene on any part of the affected foot * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percent reduction in wound area at week 4 compared to the baseline visit | Weekly measurements of wound area from study initiation and through week 4 |
Secondary
| Measure | Time frame |
|---|---|
| The percent conversion of the wound bed to granulation tissue by week 4 compared to baseline | Weekly assessments from baseline through week 4 |
| The percentage of lesions that demonstrate at least 40% reduction in area by the end of week 4 compared to baseline visit | Weekly assessments of wound area through week 4 |
| The percentage of lesions that demonstrate at least 50% reduction in area by the end of week 4 compared to baseline visit | Weekly assessments of wound area from baseline through week 4 |
Countries
Israel
Outcome results
None listed