Actively Recruiting
A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.
Led by BioLab Holdings · Updated on 2026-02-09
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
B
BioLab Holdings
Lead Sponsor
S
Serena Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study is a multicenter, prospective, controlled modified multi-platform trial assessing the efficacy of human placental membrane products and standard of care in the management of nonhealing diabetic foot ulcers and venous leg ulcers.
CONDITIONS
Official Title
A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg 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 multiple ulcers, the target ulcer must be the same one treated in the BIOCAMP study
- Consent to using the prescribed offloading method during the study
- Agree to attend weekly study visits as required
- Willing and able to participate in the informed consent process
- Participated in the BIOCAMP trial in the standard of care arm and did not achieve complete 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 in the target ulcer
- Infection requiring systemic antibiotics
- Receiving immunosuppressants or chemotherapy or taking medications interfering with wound healing
- Taking hydroxyurea
- Applied topical steroids to the ulcer within one month prior to treatment
- Previous partial amputation causing deformity that impedes offloading
- Glycated hemoglobin (HbA1c) of 12% or higher within 3 months
- 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 BIOCAMP trial
- Participated in BIOCAMP trial but not in the standard of care arm
- Achieved complete closure in BIOCAMP trial
- Treated with skin substitutes or hyperbaric oxygen therapy within one month prior to treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Center for Foot and Ankle Disorders
Philidelphia, Pennsylvania, United States, 19146
Actively Recruiting
Research Team
B
Bennett Sarver
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
8
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