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New treatment option for Diabetic Foot Ulcer (DFU)
Official title Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
ClinicalTrials.gov ID: NCT06681428
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Potential people are required to meet all of the following criteria for enrollment into the study.
- At least 18 years old, inclusive.
- Presence of a DFU, Wagner Grade 1, extending through the dermis provided it is below the medial aspect of the malleolus.
- 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...
- 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.
You likely can't join if
- Potential people meeting any of the following criteria will be excluded from enrollment and subsequent treatment.
- Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes
- 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
- Index ulcer is infected
- people with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic...
- people on any investigational drug(s), Investigational products, or therapeutic device(s) within 30 days preceding SV1
See the full eligibility criteria
- Potential people are required to meet all of the following criteria for enrollment into the study.
- At least 18 years old, inclusive.
- Presence of a DFU, Wagner Grade 1, extending through the dermis provided it is below the medial aspect of the malleolus.
- 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...
- 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.
- Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
- 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...
- The target ulcer has been offloaded for at least 14 days, prior to TV1.
- 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.
- Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
- people must have read and signed the IRB approved ICF before screening procedures are performed.
- Potential people meeting any of the following criteria will be excluded from enrollment and subsequent treatment.
- Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes
- 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
- Index ulcer is infected
- people 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...
- people on any investigational drug(s), Investigational products, or therapeutic device(s) within 30 days preceding SV1
- History of radiation at the ulcer site (regardless of time since last radiation treatment)
- Index ulcer has been previously treated or will need to be treated with any prohibited therapies
- people with a previous diagnosis of HIV or Hepatitis C
- 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
- 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...
- Subject is pregnant or breast-feeding
- Presence of diabetes with poor metabolic control as documented with an HbA1c \>12.0 within last 90 days
- people with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of enrollment
- Presence of acute Charcot Neuroarthropathy to the affected limb
- Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit
The study team makes the final eligibility decision.
Where it's taking place
- Fresno, California, United States
- Los Angeles, California, United States
- Vista, California, United States
- Miami, Florida, United States
- Raleigh, North Carolina, United States
- Boardman, Ohio, United States
- Circleville, Ohio, United States
- Salem, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fresno, California, United States; Los Angeles, California, United States; Vista, California, United States; Miami, Florida, United States; Raleigh, North Carolina, United States; Boardman, Ohio, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.