Actively Recruiting
A Multicenter, Prospective, Randomized Controlled Modified Platform 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 C5 Biomedical · Updated on 2024-12-27
177
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
C
C5 Biomedical
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of multiple human placental membrane products, called CAMPs, combined with Standard of Care (SOC) versus SOC alone in treating nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). This multicenter, prospective, randomized controlled trial uses a modified platform design to compare different CAMP products, including AM/Single and AM/Double, in promoting ulcer closure over 12 weeks. Participants will receive weekly treatments depending on their assigned group. The Standard of Care involves cleaning, debridement, moisture balance, and offloading or compression as appropriate. Those in CAMP groups will receive weekly applications of either AM/Single (a single layer human amniotic membrane allograft) or AM/Double (a double layer allograft) in addition to Standard of Care. Treatment continues until the ulcer closes or up to 12 weeks. During the study, participants will attend weekly visits for treatment and evaluation. Researchers will assess ulcer closure rates, time to closure, percent area reduction, pain changes, adverse events, and quality of life improvements over 12 weeks. The study monitors participants closely to measure healing progress and safety of the treatments throughout the trial duration.
CONDITIONS
Brief 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 of age or older.
- Diagnosis of type 1 or type 2 diabetes mellitus for DFU participants.
- Target ulcer surface area between 0.7 cm2 and 20.0 cm2 measured after debridement.
- Ulcer present for at least 4 weeks and no more than 52 weeks prior to screening.
- Target ulcer on the foot with at least 50% below the malleolus for DFU.
- Ulcer must be Wagner grade 1 or 2, extending through dermis or subcutaneous tissue without exposed tendon or bone.
- Adequate limb perfusion confirmed by vascular assessment within 3 months.
- Multiple ulcers must be at least 2 cm apart; largest ulcer chosen as target.
- Target ulcer must be offloaded at least 14 days prior to enrollment for DFU.
- Agreement to use prescribed offloading method.
- Willingness and ability to attend weekly study visits and participate in informed consent.
- For VLU participants, target ulcer must show less than 40% size reduction in last 4 weeks.
- Adequate limb perfusion confirmed by vascular assessment within 3 months for VLU.
- Multiple ulcers must be at least 2 cm apart; largest ulcer chosen as target for VLU.
- Willingness and ability to attend weekly visits and participate in consent process for VLU.
You will not qualify if you...
- Life expectancy less than 6 months.
- Target ulcer not caused by diabetes (for DFU).
- Infected target ulcer or cellulitis in surrounding skin.
- Ulcer exposing tendon or bone.
- Evidence of osteomyelitis complicating the ulcer.
- Current use of immunosuppressants, cytotoxic chemotherapy, or medications interfering with wound healing.
- Use of hydroxyurea.
- Topical steroids applied to ulcer surface within one month before screening.
- Previous partial amputation causing deformity that impedes offloading.
- Glycated hemoglobin (HbA1c) of 12% or higher within 3 months before screening.
- Ulcer surface area reduced by more than 20% during historical or active 2-week screening periods.
- Acute or inactive Charcot foot impeding offloading.
- Pregnancy or planning pregnancy within 6 months.
- End stage renal disease requiring dialysis.
- Participation in investigational product trial within 30 days.
- Medical or psychological conditions interfering with study assessments.
- Recent hyperbaric oxygen therapy or CAMP treatment within 30 days.
- Malnutrition indicator score below 17 on Mini Nutritional Assessment.
- For VLU, wounds with active or latent infection or risk of post-operative complications are excluded.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks or until ulcer closure
Participants receive weekly applications of human placental membrane products and standard care or standard care alone to treat diabetic foot ulcers or venous leg ulcers until ulcer closure or up to 12 weeks.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Poirot Podiatry
Metairie, Louisiana, United States, 70001
Actively Recruiting
Research Team
B
Bennett Rogers
C
Connie Chung, PhD
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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