Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs
NCT ID: NCT06674980
Last Updated: 2024-12-27
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
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RECRUITING
NA
177 participants
INTERVENTIONAL
2024-12-20
2027-01-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care - DFU
Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Off-loading using the off-loading boot or total contact cast (TCC).
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 12 weeks, whichever occurs first.
AM/Single - DFU
AM/Single is an air-dried, sterile single layer human amniotic membrane allograft.
AM/Single - DFU
Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
AM/Double - DFU
AM/Double is an air-dried, sterile double layer human amniotic membrane allograft.
AM/Double - DFU
Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Standard of Care - VLU
Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Compression using multilayer compression wraps.
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 12 weeks, whichever occurs first.
AM/Single - VLU
AM/Single is an air-dried, sterile single layer human amniotic membrane allograft.
AM/Single - VLU
Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
AM/Double - VLU
AM/Double is an air-dried, sterile double layer human amniotic membrane allograft.
AM/Double - VLU
Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Interventions
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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 12 weeks, whichever occurs first.
AM/Single - DFU
Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
AM/Double - DFU
Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 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 12 weeks, whichever occurs first.
AM/Single - VLU
Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
AM/Double - VLU
Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Eligibility Criteria
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Inclusion Criteria
2. Must have diagnosis of type 1 or 2 Diabetes mellitus.
3. At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging device.
4. Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit.
5. Target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
6. Target ulcer that is 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. The ulcer may not include exposed tendon or bone.
7. Subject's 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:
1. ABI between 0.7 and \<= 1.3
2. TBI \>= 0.6
3. TCOM \>= 40 mmHg
4. PVR: biphasic
Potential subjects are required to meet all the following criteria for enrollment in the study.
1. Subjects must be at least 18 years of age or older.
2. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20 cm2 measured post-debridement.
3. 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.
4. No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.
5. 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:
1. ABI between 0.7 and ≤ 1.3;
2. TBI ≥ 0.6;
3. TCOM ≥ 40 mmHg;
4. PVR: biphasic.
Exclusion Criteria
10. Subject must consent to using the prescribed offloading method for the duration of the study.
11. Subject must agree to attend weekly study visits.
12. Subject must be willing and able to participate in the consent process.
1. Subject is known to have a life expectancy of \< 6 months.
2. Subject's target ulcer is not secondary to diabetes.
3. Target ulcer is infected or there is cellulitis in the surrounding skin.
4. Target ulcer exposes tendon or bone.
5. Evidence of osteomyelitis complicating the target ulcer.
6. Infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
7. The 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).
8. Subject is taking hydroxyurea.
9. Subject has applied topical steroids to the ulcer surface within one month of initial screening.
10. Subject has a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
11. Subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
12. The surface area of the subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). 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).
13. The surface area measurement of the subject's target ulcer decreases by 20% or more during the active 2-week screening phase.
14. Subject has acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
15. Subject is a woman who is pregnant or considering becoming pregnant in the next 6 months.
16. Subject has end stage renal disease requiring dialysis.
17. Subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
18. The subject, in opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.
19. Subject was treated with hyperbaric oxygen therapy or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to screening.
20. Subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
7. The potential subject must agree to attend the weekly study visits required by the protocol.
8. 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 target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
3. The target ulcer exposes tendon or bone.
4. There is evidence of osteomyelitis complicating the target ulcer.
5. 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).
6. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
7. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
8. 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). 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).
9. 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.
10. Women who are pregnant or considering becoming pregnant within the next 6 months.
11. The potential subject has end stage renal disease requiring dialysis.
12. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
13. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
14. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
15. The subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
16. A subject has a wound with active or latent infection is excluded.
17. A subject with a disorder that would create unacceptable risk of post-operative complications is excluded.
18 Years
ALL
No
Sponsors
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SerenaGroup, Inc.
NETWORK
C5 Biomedical
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Serena, MD
Role: PRINCIPAL_INVESTIGATOR
SerenaGroup, Inc.
Locations
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Poirot Podiatry
Metairie, Louisiana, United States
Countries
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Central Contacts
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Facility Contacts
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Donna Belette
Role: primary
Other Identifiers
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Pro00082457
Identifier Type: -
Identifier Source: org_study_id