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New treatment option for Diabetic Foot Ulcer (DFU)
Official title Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
ClinicalTrials.gov ID: NCT07209475
What this study is testing
What is Amnio-Maxx® Dual Layer Amnion Patch?
Amnio-Maxx® Dual Layer Amnion Patch is an investigational medicine, being studied as a potential treatment for diabetic foot ulcer (dfu).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch.
- Phase 4: studies an already-approved 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 the following criteria for enrollment into the study and subsequent randomization.
- The potential subject is 18 years of age or older. At least 50% of the enrolled population must be \> 65 years of age.
- The potential subject has a history of Type I or Type II Diabetes Mellitus requiring treatment by a physician with either oral medications and/or...
- Potential people have an ulcer characterized by the following:
- Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening visit on any aspect of the foot, provided it is at or below the aspect...
You likely can't join if
- The Subject has a known life expectancy of \< 1 year.
- Index ulcer has been present for \>1 year.
- Patient does not have adequate 2-week historical data demonstrating \< 20% area reduction.
- Subject is unable to comply with offloading device.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to...
- Subject has ulcers that are completely necrotic or fibrotic tissue
See the full eligibility criteria
- Potential people are required to meet all the following criteria for enrollment into the study and subsequent randomization.
- The potential subject is 18 years of age or older. At least 50% of the enrolled population must be \> 65 years of age.
- The potential subject has a history of Type I or Type II Diabetes Mellitus requiring treatment by a physician with either oral medications and/or insulin replacement therapy.
- Potential people have an ulcer characterized by the following:
- Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening visit on any aspect of the foot, provided it is at or below the aspect of the medial malleolus. [NOTE: If two or more DFUs are present with...
- A diabetic foot ulcer present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.
- Objectively, less than 20% healing in the two-week screening period prior to randomization.
- Study ulcer is a minimum of 1.0cm2 and a maximum of 25 cm2 post-debridement at first treatment visit.
- Index ulcer and/or index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1
- The subject is able and willing to follow the protocol requirements.
- Subject has signed informed consent. Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg; an ABI...
- The Subject has a known life expectancy of \< 1 year.
- Index ulcer has been present for \>1 year.
- Patient does not have adequate 2-week historical data demonstrating \< 20% area reduction.
- Subject is unable to comply with offloading device.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
- Subject has ulcers that are completely necrotic or fibrotic tissue
- Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- Subject currently being treated for an active malignant disease
- or people with history of malignancy within the ulcer.
- The Subject has other concurrent conditions that in the opinion of the Principal Investigator may compromise subject safety.
- Known contraindications to amniotic tissue membranes or known allergies to any of the Amnio-Maxx components.
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Index ulcer has reduced in area by 20% or more after 2 weeks of standard of care from the first screening visit (S1) to the TV1/randomization visit.
- Subject is pregnant or breastfeeding.
- people with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids
- \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 30 days prior to randomization visit or who receive such medications during the screening period, or who are...
- Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days preceding the first treatment visit. \-
The study team makes the final eligibility decision.
Where it's taking place
- Burbank, California, United States
- Miami, Florida, United States
- Stone Mountain, Georgia, United States
- Omaha, Nebraska, United States
- East Patchogue, New York, United States
- Tulsa, Oklahoma, United States
- Carrollton, Texas, United States
- Spicewood, Texas, 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 Burbank, California, United States; Miami, Florida, United States; Stone Mountain, Georgia, United States; Omaha, Nebraska, United States; East Patchogue, New York, United States; Tulsa, Oklahoma, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.