Actively Recruiting
Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Led by BioLab Holdings · Updated on 2025-07-28
650
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
B
BioLab Holdings
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.
CONDITIONS
Official Title
Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone 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
- Diagnosis of type 1 or type 2 diabetes mellitus
- Target ulcer surface area between 1.0 cm2 and 20 cm2 measured after debridement
- Ulcer present for at least 4 weeks under standard care before screening
- Ulcer located on foot with at least 50% below the malleolus
- Ulcer is Wagner grade 1 or 2, affecting dermis, subcutaneous tissue, or muscle below medial malleolus without exposed tendon or bone
- Adequate blood flow in affected limb confirmed by vascular tests within 3 months
- If multiple ulcers, target ulcer is largest and ulcers are at least 2 cm apart
- Agree to use prescribed offloading method during study
- Agree to attend weekly study visits
- Willing and able to consent to study participation
You will not qualify if you...
- Life expectancy less than 6 months
- Ulcer not caused by diabetes
- Infected ulcer or cellulitis in surrounding skin
- Ulcer with exposed tendon or bone
- Evidence of osteomyelitis in target ulcer
- Infection requiring systemic antibiotics
- Use of immunosuppressants, cytotoxic chemotherapy, or medications interfering with wound healing
- Use of hydroxyurea
- Use of topical steroids on ulcer within 1 month prior to screening
- Partial foot amputation causing deformity that prevents proper offloading
- HbA1c 12% or higher within 3 months prior to screening
- Ulcer size reduced by over 40% in 4 weeks before treatment or over 20% in 2 weeks before screening and further 25% reduction during 2-week screening
- Acute or inactive Charcot foot preventing proper offloading
- Pregnant or planning pregnancy within 6 months
- End stage renal disease requiring dialysis
- Participation in another investigational product trial within 30 days
- Medical or psychological condition interfering with study assessments
- Hyperbaric oxygen therapy or cellular/acellular matrix product treatment within 30 days prior to screening
- Malnutrition indicator score less than 17 on Mini Nutritional Assessment
- Active or latent infection in wound
- Disorder increasing risk of post-operative complications
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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