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Cancer Vaccine
E-GRAFT + FIBRACOL for Foot Ulcer
Roanoke, VA
N/A
Recruiting
Led By Charles M Zelen, DPM FACFAS
Research Sponsored by Skye Biologics Holdings, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be at least 18 years of age or older
Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus
Must not have
A potential subject with end stage renal disease requiring dialysis is excluded
A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare the effectiveness of two different wound treatments, E-GRAFT™ and FIBRACOL™, with the standard treatment. The study will look at the rate of wound closure
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Who is the study for?
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.Check my eligibility
What is being tested?
The study compares E-GRAFT™ combined with Standard of Care (SOC) against FIBRACOL™ plus SOC in healing diabetic foot ulcers. It will assess wound closure rate, change in ulcer size over time, side effects, nerve damage changes, pain levels, and infection rates.See study design
What are the potential side effects?
Potential side effects may include adverse reactions at the treatment site such as increased pain or infection risk; however specific side effects related to E-GRAFT™ or FIBRACOL™ will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have been diagnosed with type 1 or type 2 diabetes.
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My diabetic foot ulcer is between 1.0 and 10.0 cm2 after cleaning.
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My foot ulcer is mostly below my ankle.
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My foot or ankle ulcer is deep but does not reach the bone.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have end stage kidney disease requiring dialysis.
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I am not on high-dose steroids or chemotherapy drugs that suppress my immune system.
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I do not have an active or inactive Charcot foot that affects wound healing.
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I have not had hyperbaric oxygen therapy or cell/tissue treatments in the last 30 days.
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My target ulcer is not infected, and there's no cellulitis around it.
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I have a bone infection or exposed bone confirmed by a doctor's exam or X-rays.
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I have not had a foot amputation that affects my ability to relieve pressure on a foot ulcer.
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My target ulcer has not shrunk by more than 30% in the last 2 weeks.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Comparison of the proportion of index ulcers "healed" at 12-weeks
Secondary study objectives
Change in pain levels during trial
Changes in peripheral neuropathy
Percentage Area Reduction over12 week period
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SOC primary dressing with E-GRAFT ™Experimental Treatment1 Intervention
Participants receive standard of care with E-GRAFT™
Group II: SOC primary dressing with FIBRACOL™Active Control1 Intervention
Participants receive standard of care with FIBRACOL™
Find a Location
Closest Location:Professional Education and Research Institute· Roanoke, VA· 250 miles
Who is running the clinical trial?
Skye Biologics Holdings, LLCLead Sponsor
3 Previous Clinical Trials
435 Total Patients Enrolled
Charles M Zelen, DPM FACFASPrincipal InvestigatorProfessional Education and Research Institute
1 Previous Clinical Trials
100 Total Patients Enrolled