Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)
NCT ID: NCT07014176
Last Updated: 2025-10-21
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
PHASE4
120 participants
INTERVENTIONAL
2025-07-03
2026-10-31
Brief Summary
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Detailed Description
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Advanced wound products like Dehydrated Human Placental Tissue (dHPTs) have become an important strategy in the treatment of these chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.
This study will evaluate the clinical utility of Amnion-Intermediate-Chorion (AIC) in the closure of diabetic foot ulcers in subjects in comparison to Standard of Care treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care
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.
Standard of Care (SOC)
Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.
AIC and Standard of Care
Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Intermediate-Chorion (AIC) sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and 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.
Amnion-Intermediate-Chorion
Dehydrated human placental multilayer allograft from derived donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
Standard of Care (SOC)
Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.
Interventions
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Amnion-Intermediate-Chorion
Dehydrated human placental multilayer allograft from derived donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
Standard of Care (SOC)
Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.
Eligibility Criteria
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Inclusion Criteria
1. 18 years of age or older.
2. Diagnosis of type 1 or 2 Diabetes mellitus.
3. Hemoglobin A1c (HbA1c) level is \< 12% (108 mmol/mol).
4. Target ulcer with a surface area at randomization of 0.7 cm2 to 20.0 cm2 measured post debridement.
5. Target ulcer present for minimum of 4 weeks prior to screening visit.
6. Target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
7. 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. The ulcer may not include exposed tendon or bone.
8. Affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the screening visit are acceptable:
1. ABI ≥ 0.7 and ≤ 1.3;
2. TBI ≥ 0.6;
3. TCOM ≥ 40 mmHg;
4. PVR: biphasic or triphasic.
Exclusion Criteria
11. Subject must agree to attend study visits required by the protocol.
12. Subject must be willing and able to participate in the informed consent process.
Subjects will be excluded from participation in the study if any of the following conditions exist:
1. Known life expectancy of \< 6 months.
2. Target ulcer is not secondary to diabetes.
3. Target ulcer is infected or there is cellulitis in the surrounding skin.
4. Evidence of osteomyelitis complicating the target ulcer.
5. Infection in the target ulcer or a location that requires systemic antibiotic therapy.
6. Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
7. Topical application of steroids to the ulcer surface within one month of screening.
8. Previous partial amputation on the affected foot if the resulting deformity impedes proper offloading of the target ulcer.
9. Surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to screening visit ("historical" run-in period). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).
10. Mini Nutritional Assessment (MNA) score of less than 17.
11. Acute Charcot foot or an inactive Charcot foot that impedes proper offloading of the target ulcer.
12. Women of childbearing potential (WOCBP) who are pregnant, considering becoming pregnant within the next 4 months, or are unwilling to use an appropriate form of contraception.
13. Currently require dialysis or planning to start dialysis.
14. Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.
15. Treated with hyperbaric oxygen therapy or a dehydrated human placental tissue (dHTP) in the 30 days prior to screening visit.
16. Known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
18 Years
ALL
No
Sponsors
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Cellution Biologics
INDUSTRY
Responsible Party
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Principal Investigators
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Research Director
Role: STUDY_DIRECTOR
Cellution Biologics
Locations
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005
Santa Rosa, California, United States
001
Jacksonville, Florida, United States
003
Chicago, Illinois, United States
007
Mooresville, North Carolina, United States
002
Rocky Mount, North Carolina, United States
008
Allentown, Pennsylvania, United States
004
Philadelphia, Pennsylvania, United States
006
Hilton Head Island, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CELLBIO-2025-001
Identifier Type: -
Identifier Source: org_study_id
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