Actively Recruiting
Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
Led by Stability Biologics · Updated on 2025-01-20
324
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Stability Biologics
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot and venous leg ulcers.
CONDITIONS
Official Title
Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 21 years old or older
- Have type 1 or type 2 diabetes
- Have a target ulcer with a size between 1.0 cm2 and 5.0 cm2 after cleaning
- Have the 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% below the ankle bone
- Have a Wagner grade 1 or 2 ulcer extending through skin layers and possibly muscle below the inner ankle
- Have adequate blood flow in the affected limb confirmed by tests done within 3 months
- If multiple ulcers, they must be at least 2 cm apart; the largest qualifying ulcer is the target
- Ulcers on the sole of the foot must be offloaded for at least 14 days before enrollment
- Agree to use the prescribed offloading method during the study
- Agree to attend weekly study visits
- Be willing and able to participate in informed consent
You will not qualify if you...
- Life expectancy less than 6 months
- Ulcer not caused by diabetes
- Ulcer is infected, needs systemic antibiotics, or has surrounding skin infection
- Ulcer exposes tendon or bone
- Ulcer complicated by bone infection (osteomyelitis)
- Taking immunosuppressants, systemic corticosteroids over 10 mg prednisone daily, cytotoxic chemotherapy, or medications interfering with healing
- Taking hydroxyurea
- Used topical steroids on the ulcer in the past month
- Previous partial amputation of the affected foot causing deformity that prevents proper offloading
- Hemoglobin A1c (HbA1c) of 12% or higher within 3 months before screening
- Target ulcer size decreased by more than 20% in the two weeks before screening
- Target ulcer size decreased by 20% or more during the 2-week screening phase with standard care
- Have acute or inactive Charcot foot that prevents proper offloading
- Women who are pregnant or planning pregnancy within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cutting Edge Research
Circleville, Ohio, United States, 43113
Actively Recruiting
Research Team
B
Bennett M Rogers
CONTACT
T
Thomas Serena, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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