E-GRAFT + FIBRACOL for Foot Ulcer
What You Need to Know Before You Apply
What is the purpose of this trial?
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC. Other research purposes include the following:* Rate of wound closure* Change in ulcer size over 12 weeks* Any adverse events or reactions (side effects)* Changes in neuropathy (nerve damage)* Change in pain levels* Occurrence of infection
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants or high doses of corticosteroids, you may not be eligible to participate.
Is E-GRAFT + FIBRACOL safe for treating foot ulcers?
The safety of a similar treatment, Heberprot-P, for diabetic foot ulcers was studied, and it was generally safe with some side effects like tremors, chills, pain, and local infection. This suggests that treatments like E-GRAFT + FIBRACOL might also be safe, but specific safety data for E-GRAFT + FIBRACOL is not available.12345
What data supports the effectiveness of the treatment E-GRAFT ™ and FIBRACOL™ for foot ulcers?
Research shows that treatments like epidermal growth factor (EGF) can help heal diabetic foot ulcers by promoting skin repair. Additionally, other types of skin grafts, such as acellular fish skin grafts, have been effective in healing foot ulcers, suggesting that similar treatments might also be beneficial.23678
Who Is on the Research Team?
Charles M Zelen, DPM FACFAS
Principal Investigator
Professional Education and Research Institute
Are You a Good Fit for This Trial?
This trial is for adults over 18 with type 1 or 2 diabetes who have had a non-healing foot ulcer for 4-52 weeks. The ulcer must be on the foot, not probe to bone, and measure between 1.0 cm² and 10.0 cm² after debridement. Participants need adequate blood flow to the foot and must commit to weekly visits and prescribed off-loading methods.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either E-GRAFT™ or FIBRACOL™ as the primary dressing along with standard of care for diabetic foot ulcers
Follow-up
Participants are monitored for safety, effectiveness, and any adverse events after treatment
What Are the Treatments Tested in This Trial?
Interventions
- E-GRAFT ™
- FIBRACOL™
Find a Clinic Near You
Who Is Running the Clinical Trial?
Skye Biologics Holdings, LLC
Lead Sponsor