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New treatment option for Diabetic Foot Ulcer
Official title Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management
ClinicalTrials.gov ID: NCT06420245
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if use of Orion™, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot ulcers. The study aims to determine the incidence of complete wound closure at the end of 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 50 to 85
You may be able to join if
- Ambulatory patients ≥ 50 and ≤ 85 years of age;
- Willing and able to provide informed consent;
- Willing and able to comply with study requirements;
- Presence of Wagner 1 and superficial Wagner 2 DFU extending at least through the dermis provided the DFU is located in the foot distal to the medial...
- If multiple Wagner 1 and superficial Wagner 2 DFUs are present, the largest ulcer meeting DFU eligibility criteria will be selected as the index DFU...
You likely can't join if
- Index foot ulcer documented to be caused by a medical condition other than diabetes;
- Potential subject has five (5) or more DFUs and/or VLUs in the target limb;
- DFU is secondary to Charcot neuroarthropathy;
- Treatment with an antibiotic impregnated primary dressing ≤ 4 weeks prior to study screening;
- Index ulcer is potentially or confirmed by biopsy to be cancerous;
- Index ulcer site has undergone radiation therapy;
See the full eligibility criteria
Who can join
- Ambulatory patients ≥ 50 and ≤ 85 years of age;
- Willing and able to provide informed consent;
- Willing and able to comply with study requirements;
- Presence of Wagner 1 and superficial Wagner 2 DFU extending at least through the dermis provided the DFU is located in the foot distal to the medial malleolus
- If multiple Wagner 1 and superficial Wagner 2 DFUs are present, the largest ulcer meeting DFU eligibility criteria will be selected as the index DFU in the study;
- Index ulcer is able to be visualized and accurately measured with eKare Insights;
- Non-study ulcers must be \> 2 cm (.79 in.) from the index ulcer;
- Index DFU identified ≥ 4 weeks prior to study screening and \< 52 weeks from the date of informed consent;
- Index DFU area \> 1.0 cm2 (0.39 in.) and \< 25 cm2 (9.84 in.) at screening and at Wound Management Period Visit #1;
- Index DFU offloaded according to SOC for entire run-in period, prior to randomization;
- Potential participant is under the care of a clinician for diabetic management and other medical conditions (the site PI may assist/direct the patient in the pre-screening period to obtain a PCP).
- Index foot has adequate circulation defined as meeting one (1) of the following within 30 days of screening: A. ABI ≥ 0.7 and ≤ 1.3 AND TBI \> 0.7; B. Dorsum transcutaneous oxygen tension measurement (TcPO2) ≥ 40 mmHg...
What rules you out
- Index foot ulcer documented to be caused by a medical condition other than diabetes;
- Potential subject has five (5) or more DFUs and/or VLUs in the target limb;
- DFU is secondary to Charcot neuroarthropathy;
- Treatment with an antibiotic impregnated primary dressing ≤ 4 weeks prior to study screening;
- Index ulcer is potentially or confirmed by biopsy to be cancerous;
- Index ulcer site has undergone radiation therapy;
- Venous leg ulcers in diabetic patients;
- Active infection proximal to or at site of index ulcer;
- Index foot ulcer reduced in area by ≥ 20% at the end of the 4-week run-in period;
- Presence of active osteomyelitis or bone infection as verified by x-ray /MRI within 30 days of visit #1 of the run-in period;
- Raynaud's disease;
- Unreconstructible arterial ischemia which may lead to nonhealing;
- Treatment with immunosuppressants, including systemic corticosteroids for ≥ 2 weeks within 30 days prior to study screening, or are anticipated during study participation;
- Any active cancer undergoing treatment ≤ 30 days prior to wound management visit #1 of the run-in period, or is anticipated during study participation;
- Treatment with chemotherapy within 30 days of the first study wound management visit of the run-in period, or is anticipated during study participation;
- Diabetics with poor metabolic control, defined as HbA1c ≥ 12.0%, within 30 days of visit #1 of the run-in period;
- Participation in an investigational device, biologic, or drug study currently or within 30 days of study wound management visit #1 of the run-in period;
- Prior use of any advanced skin substitute product on the index ulcer within 60 days of visit #1 of the run-in period;
- Index ulcer was continued to be treated after visit #1 of the run-in period and/or anticipate treatment during study participation with any of the following prohibited therapies:
- Biomedical or topical growth factor;
- Topical steroids applied to the index ulcer surface;
- On medications that are considered immune system modulators that could affect graft incorporation;
- Scarlet red dressing;
- Dakin's solution;
- Mafenide acetate;
- Tincoban;
- Zinc sulfate;
- Povidone-iodine solution;
- Polymyxin/nystatin;
- Chlorhexidine;
- Patient is taking a cyclooxygenase-2 inhibitor (COX-2 inhibitor); such as, celecoxib (Celebrex, Consensi, Elyxyb), valdecoxib (Bextra), amlodipine (Consensi);
- Patient has serum creatinine \> 2.5 mg/dL within 30 days of study wound management visit #1 of the run-in period;
- Autoimmune connective tissue disease;
- End stage renal disease (ESRD);
- Presence of any condition which would seriously compromise the subject's ability to complete this study;
- Known history of poor adherence to medical therapy and/or clinic appointments;
- Pregnant, or planning to become pregnant during the study;
- Life expectancy \< 1 year.
The study team makes the final eligibility decision.
Where it's taking place
- Palm Springs, California, United States
- San Francisco, California, United States
- Vista, California, United States
- Darien, Connecticut, United States
- Pembroke Pines, Florida, United States
- Chicago, Illinois, United States
- Pasadena, Maryland, United States
- Portland, Oregon, 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, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palm Springs, California, United States; San Francisco, California, United States; Vista, California, United States; Darien, Connecticut, United States; Pembroke Pines, Florida, United States; Chicago, Illinois, 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.