Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
NCT ID: NCT06560502
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
324 participants
INTERVENTIONAL
2024-08-01
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers
NCT06453187
Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers
NCT06562296
Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs
NCT06674980
Modified Platform Trial Assessing Multiple CAMPs and SOC Vs SOC Alone in the Treatment of Hard-to-Heal DFUs
NCT06449638
Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.
NCT06826339
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
\*The initial plan is to evaluate five CAMPs per wound type; however, the modified platform design permits the inclusion of additional CAMPs.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard of Care-DFU
Debridement, reduction of bacterial burden, and proper moisture balance using dressings provided by SerenaGroup. Off-loading using the off-loading boot or total contact cast (TCC) provided by SerenaGroup.
Standard of Care-DFU
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
AmnioCore - DFU
Dual layer, amniotic membrane allograft.
AmnioCore - DFU
Participants will receive weekly applications of AmnioCore and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amnio Quad-Core - DFU
Four layer, amniotic membrane allograft.
Amnio Quad-Core - DFU
Participants will receive weekly applications of Amnio Quad-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amniocore Pro + - DFU
Dual layer, amnion/chorion membrane allograft.
Amniocore Pro +
Participants will receive weekly applications of Amniocore Pro + and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Standard of Care-VLU
Debridement, reduction of bacterial burden, and proper moisture balance using dressings provided by SerenaGroup. Compression using multilayer compression wraps provided by SerenaGroup.
Standard of Care-VLU
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amnio Tri-Core - VLU
Three layer, amniotic membrane allograft.
Amnio Tri-Core - VLU
Participants will receive weekly applications of Amnio Tri-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
AmnioCore Pro - VLU
Three layer, amnion/chorion/amnion membrane allograft.
AmnioCore Pro
Participants will receive weekly applications of AmnioCore Pro and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard of Care-DFU
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
AmnioCore - DFU
Participants will receive weekly applications of AmnioCore and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amnio Quad-Core - DFU
Participants will receive weekly applications of Amnio Quad-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Standard of Care-VLU
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amnio Tri-Core - VLU
Participants will receive weekly applications of Amnio Tri-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
AmnioCore Pro
Participants will receive weekly applications of AmnioCore Pro and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amniocore Pro +
Participants will receive weekly applications of Amniocore Pro + and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
4\. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
5\. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
6\. The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus.
7\. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
Exclusion Criteria
10\. The potential subject must consent to using the prescribed offloading method for the duration of the study.
11\. The potential subject must agree to attend the weekly study visits required by the protocol.
12\. The potential subject must be willing and able to participate in the informed consent process.
1. The potential subject is known to have a life expectancy of \< 6 months.
2. The potential subject's target ulcer is not secondary to diabetes.
3. The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
4. The target ulcer exposes tendon or bone.
5. There is evidence of osteomyelitis complicating the target ulcer.
6. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
7. The potential subject is taking hydroxyurea .
8. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
9. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
10. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
11. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). MolecuLight Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
12. The surface area measurement of the Target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.
13. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
14. Women who are pregnant or considering becoming pregnant within the next 6 months.
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
SerenaGroup, Inc.
NETWORK
Stability Biologics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cutting Edge Research
Circleville, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Brock Liden, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STABLECAMP
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.