Actively Recruiting
Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs
Led by C5 Biomedical · Updated on 2024-12-27
177
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
Sponsors
C
C5 Biomedical
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.
CONDITIONS
Official Title
Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Diagnosed with type 1 or type 2 diabetes (for diabetic foot ulcer group)
- Have a target ulcer between 0.7 cm2 and 20 cm2 after cleaning and debridement
- Ulcer present for at least 4 weeks and no more than 52 weeks of prior standard care
- Target ulcer located on the foot with at least 50% below the malleolus (for diabetic foot ulcers)
- Ulcer classified as Wagner grade 1 or 2 without exposed tendon or bone
- Adequate blood flow to the affected limb confirmed by vascular tests within 3 months
- If multiple ulcers, at least 2 cm apart; largest ulcer chosen as target
- Ulcer on the bottom of the foot and offloaded for at least 14 days before enrollment
- Agree to use prescribed offloading method throughout the study
- Agree to attend weekly study visits
- Willing and able to provide informed consent (for venous leg ulcers, similar criteria apply with focus on ulcer size, duration, healing signs, and perfusion)
You will not qualify if you...
- Life expectancy less than 6 months
- Ulcer not caused by diabetes (for diabetic foot ulcers)
- Infected ulcer or cellulitis around the ulcer
- Ulcer exposing tendon or bone
- Evidence of bone infection (osteomyelitis) in the ulcer area
- Currently taking immunosuppressants, cytotoxic chemotherapy, or certain medications affecting wound healing
- Using hydroxyurea
- Applied topical steroids to the ulcer within one month before screening
- Previous foot amputation causing deformity affecting ulcer offloading
- HbA1c level 12% or higher within 3 months before screening
- Ulcer size reduced by more than 20% in the 2 weeks before screening or during the 2-week screening phase
- Acute or inactive Charcot foot affecting ulcer offloading
- Pregnant or planning pregnancy within 6 months
- End-stage kidney disease requiring dialysis
- Participated in another investigational treatment trial within 30 days
- Medical or psychological condition interfering with study assessments
- Received hyperbaric oxygen therapy or CAMP treatment within 30 days
- Malnutrition score below 17 on Mini Nutritional Assessment
- Wound with active or latent infection (for venous leg ulcers)
- Conditions causing unacceptable risk of surgical complications (for venous leg ulcers)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Poirot Podiatry
Metairie, Louisiana, United States, 70001
Actively Recruiting
Research Team
B
Bennett Rogers
CONTACT
C
Connie Chung, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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