Clinical trial NCT06681428: Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
Official title: A Multi-Center, Randomized Controlled Clinical Investigation Evaluating an Amnion/Chorion/Amnion Allograft, Amnion/Chorion Allograft, And/or an Amnion/Amnion Allograft Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer (DFU)
Chronic Foot Ulcers
Keywords: Amnion
Chorion
Amnion Amnion Graft
Amnion Chorion Amnion Grafts
Amnion Chorion Graft
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Ulcer
Skin Ulcer
Chronic Ulcer
Chronic Foot Ulcer
Diabetic Angiopathies
Diabetes Type 2
Diabetes Type II
Leg Ulcer
Placental-Based Allografts
Human Placental-Based Skin Grafts
Skin Wound Covering
Lead sponsor: Tides Medical
Sponsor class: INDUSTRY
Collaborators: name: Professional Education and Research Institute
First posted: 2024-11-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

Potential subjects are required to meet all of the following criteria for enrollment into the study.

1. At least 18 years old, inclusive.
2. Presence of a DFU, Wagner Grade 1, extending through the dermis provided it is below the medial aspect of the malleolus.
3. The index ulcer (ulcer to be evaluated in the study) will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
4. Index ulcer has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
5. Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
6. Within 3 months of SV1, adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 using the affected study extremity. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \> 0.6 is acceptable.
7. The target ulcer has been offloaded for at least 14 days, prior to TV1.
8. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
9. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
10. Subjects must have read and signed the IRB approved ICF before screening procedures are performed.

Exclusion Criteria:

Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent treatment.

1. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes
2. Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer
3. Index ulcer is infected
4. Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study
5. Subjects on any investigational drug(s), Investigational products, or therapeutic device(s) within 30 days preceding SV1
6. History of radiation at the ulcer site (regardless of time since last radiation treatment)
7. Index ulcer has been previously treated or will need to be treated with any prohibited therapies
8. Subjects with a previous diagnosis of HIV or Hepatitis C
9. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment
10. Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision)
11. Subject is pregnant or breast-feeding
12. Presence of diabetes with poor metabolic control as documented with an HbA1c \>12.0 within last 90 days
13. Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of enrollment
14. Presence of acute Charcot Neuroarthropathy to the affected limb
15. Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit

Primary outcomes:
measure: Percentage of DFUs healed at 12 weeks
timeFrame: 12 Weeks
Secondary outcomes:
measure: Total time to DFU wound closure
timeFrame: 12 Weeks
measure: Percentage of Wound Area Reduction over time of study
timeFrame: 12 Weeks
measure: Change in perceived patient wound pain levels over time.
timeFrame: 12 weeks
Other outcomes:
measure: Cost of Treatment to Closure Diabetic Foot Ulcer Wound in Study
timeFrame: 12 Weeks
Locations:
city: Fresno
country: United States
facility: Limb Preservation Platform Inc
state: California
city: Los Angeles
country: United States
facility: Angel City Research
state: California
city: Los Angeles
country: United States
facility: Clemente Clinical Research
state: California
city: Vista
country: United States
facility: ILD Research Center
state: California
city: Miami
country: United States
facility: Clever Medical Research
state: Florida
city: Raleigh
country: United States
facility: Foot and Ankle Specialists of the Mid-Atlantic
state: North Carolina
city: Boardman
country: United States
facility: Lower Extremity Institute of Research and Therapy
state: Ohio
city: Circleville
country: United States
facility: Brock Liden DPM
state: Ohio
city: Salem
country: United States
facility: Foot and Ankle Specialists of the Mid-Atlantic
state: Virginia
Study officials:
affiliation: Keck School of Medicine of USC
name: David G Armstrong, DPM, MD, PhD
role: STUDY_CHAIR
affiliation: Tides Medical
name: Frank Burrows, MBA, EMT, BCMAS, CWCA
role: STUDY_DIRECTOR
References: