Actively Recruiting
A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
Led by Applied Biologics, LLC · Updated on 2026-02-11
60
Participants Needed
1
Research Sites
100 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 multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.
CONDITIONS
Official Title
A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Diagnosed with type 1 or type 2 diabetes mellitus
- If having multiple ulcers, the target ulcer must be the same one treated in the CAMPX study
- Agree to use the prescribed offloading method during the study
- Willing to attend weekly study visits as required
- Able and willing to participate in the informed consent process
- Previously participated in the CAMPX trial standard care arm without complete ulcer closure by 12 weeks
You will not qualify if you...
- Life expectancy less than 6 months
- Target ulcer not caused by diabetes
- Target ulcer is infected or surrounded by cellulitis
- Target ulcer exposes tendon or bone
- Evidence of osteomyelitis affecting the target ulcer
- Infection requiring systemic antibiotics
- Use of immunosuppressants, cytotoxic chemotherapy, or medications interfering with wound healing
- Use of topical steroids on ulcer within one month before screening
- Previous partial amputation causing deformity that impedes offloading
- HbA1c 12% or higher within 3 months before screening
- Acute or inactive Charcot foot impeding offloading
- Pregnant or planning pregnancy within 6 months
- End stage renal disease requiring dialysis
- Medical or psychological condition interfering with study assessments
- Malnutrition indicator score less than 17
- Did not participate in the CAMPX trial
- Participated in CAMPX but not randomized to standard care only arm
- Achieved complete ulcer closure in CAMPX trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Royal Research
Hollywood, Florida, United States, 33024
Actively Recruiting
Research Team
B
Bennett Sarver
CONTACT
T
Thomas Serena, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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