Actively Recruiting
Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care
Led by Applied Biologics, LLC · Updated on 2024-11-20
124
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
Sponsors
A
Applied Biologics, LLC
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers
CONDITIONS
Official Title
Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years old or older
- Have type 1 or type 2 Diabetes mellitus
- Have a target ulcer on the foot with a surface area between 0.7 cm2 and 20.0 cm2 measured after debridement
- Have a foot ulcer present for at least 4 weeks and no more than 52 weeks of standard care before screening
- Have the ulcer located on the foot with at least 50% of it below the malleolus
- Have a Wager grade 1 or 2 ulcer extending through dermis or subcutaneous tissue without exposed tendon or bone
- Have adequate blood flow to the affected limb confirmed by vascular tests within 3 months
- If having multiple ulcers, they must be at least 2 cm apart; the largest ulcer meeting criteria is the target ulcer
- Agree to use the prescribed off-loading method during the study
- Agree to attend weekly study visits
- Be willing and able to give informed consent
You will not qualify if you...
- Have a life expectancy less than 6 months
- Have a target ulcer not caused by diabetes
- Have an infected target ulcer or cellulitis around the ulcer
- Have osteomyelitis complicating the target ulcer
- Have any infection requiring systemic antibiotics
- Be receiving immunosuppressants or chemotherapy
- Have used topical steroids on the ulcer within one month prior to screening
- Have a previous partial amputation on the affected foot that prevents proper offloading
- Have a glycated hemoglobin (HbA1c) of 12% or higher within 3 months before screening
- Have had the target ulcer reduce in size by more than 20% in the 2 weeks before screening
- Have the target ulcer reduce by 20% or more during the 2-week screening phase
- Have an acute or inactive Charcot foot that impedes proper offloading
- Be a woman who is pregnant or planning pregnancy within 6 months
- Have end stage renal disease requiring dialysis
- Have medical or psychological conditions interfering with study assessments
- Have been treated with hyperbaric oxygen therapy or a cellular/tissue product within 30 days prior to screening
- Have a malnutrition score below 17 on the Mini Nutritional Assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Detroit Foot and Ankle
Clinton Township, Michigan, United States, 48038
Actively Recruiting
Research Team
B
Bennett Rogers
CONTACT
T
Thomas Serena
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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