Diabetic Foot Ulcer
Conditions
Keywords
diabetes, diabetic foot ulcer, wound, hydrogel, diabetes mellitus
Brief summary
This is an IRB-approved multicenter study.This non-inferiority study aims to evaluate differential healing rates between Lavior Diabetic Wound Gel and other Hydrogels. Study therapy will be started in the outpatient setting and followed accordingly.
Interventions
DRUGLavior Diabetic Wound Gel
Daily application of hydrogel treatment for 60 days.
DRUGSmith & Nephew Solosite Gel Hydrogel Wound Dressing
Daily application of hydrogel treatment for 60 days.
Sponsors
Lavior Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The Study Participant, The Care Provider, and the Investigator are all blinded from the treatments.
Intervention model description
Multicenter, randomized controlled, double-blinded clinical Non-inferiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Foot Wound in the setting of Diabetes Mellitus * Written informed consent * Minimum wound surface area of 0.7 x 0.7 cm (0.49 square cm)
Exclusion criteria
* Age \< 18 years * Noncompliance with study procedures, visit schedule or follow up Gangrene and/or untreatable Peripheral Arterial Disease * Malignancy of the wound * Use of any other hydrogels not being studied in this investigation within 1 month of being enrolled * Dry, uninfected, stable pressure ulcers of the heel * Dry, stable eschar in arterial wounds * Simultaneous participation in competing clinical trials * Pregnancy or Nursing mothers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | 60 days | The primary endpoint of this trial is defined as time (number of days) to achieve complete wound closure in study participants where closure was observed on or before Day 60. The primary endpoint of this trial is defined as time (number of days) to achieve complete wound closure in study participants where closure was observed on or before Day 60. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence | 60 days | Recurrence of wound opening after initial closure and confirmed wound closure will be assessed and compared between the treatment groups. |
| Change in wound depth over time (cm) | 60 Days | Change in wound depth (cm) over time will be evaluated by measurement of wound depth (cm) over time |
| Incidence of wound closures within 60 days | 60 days | The incidence of wound closure achieved within each treatment arm will be evaluated after a maximum study observation/treatment period of 60 days |
| Change of wound size over time (cm) | 60 days | Change of Necrotic wound bed surface area (cm) will be evaluated by measurement of necrotic area of wound (cm) over time. Photographic details of wound will be captured at each visit with standardized disposable ruler (cm). |
| Change in Pain Scores over time (60 days) | 60 days | Change in pain scores will be recorded over time (60 days) through the use of a patient reported 0 -10 scale. |
| Change in wound surface area over time (cm) | 60 Days | Change in wound surface area (cm) over time will be evaluated by measurement of wound surface area (cm) over time. |
Countries
United States
Outcome results
None listed