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Compares treatment options for Wound Heal
Official title IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
ClinicalTrials.gov ID: NCT06616844
What this study is testing
- What it's testing
- A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.
- Which group you join is decided by chance.
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
- Inclusion:
- people at least 21 years old. At least 50% of the enrolled population must be \> 65 years of age.
- Known history of type 1 or type 2 diabetes.
- The patient must have a target ulcer meeting the following characteristics: i. A diabetic ulcer that is either Wagner Grade 1 or Wagner Grade 2 . ii...
- If two or more diabetic foot ulcers with the same Wagner Grade are present, the Index ulcer must additionally be: i. the ulcer with the largest wound...
See the full eligibility criteria
- Inclusion:
- people at least 21 years old. At least 50% of the enrolled population must be \> 65 years of age.
- Known history of type 1 or type 2 diabetes.
- The patient must have a target ulcer meeting the following characteristics: i. A diabetic ulcer that is either Wagner Grade 1 or Wagner Grade 2 . ii. Located on the anatomical foot; defined as a minimum of 50% of ulcer...
- If two or more diabetic foot ulcers with the same Wagner Grade are present, the Index ulcer must additionally be: i. the ulcer with the largest wound area; ii. ≥ 2cm distant from any other ulcer on the affected limb...
- Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following within the past 30 days i. ABI ≥ 0.7 and ≤ 1.3; ii. TBI ≥ 0.6; iii. TCOM ≥ 40 mmHg; iv. PVR: biphasic.
- BMI ≤45
- Subject is willing to participate in all procedures and follow-up evaluations necessary to complete the study.
- Subject has signed informed consent. Exclusion:
- The potential subject is known to have a life expectancy of \<6 months.
- Index Ulcers will be excluded if they meet any of the following criteria upon assessment: i. Index ulcer determined to be due to a condition other than diabetes ii. Active Charcot deformity OR major structural...
- The target ulcer exhibits 2 or more of the following signs or symptoms consistent with clinical infection: i. erythema that extends ≥ 0.5cm from wound edge ii. local increased warmth iii. purulent exudate iv. local...
- Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator\'s exam or radiographic evidence.
- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent), radiation therapy, cytotoxic chemotherapy, or is taking...
- The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
- The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- The surface area of the target ulcer, as measured by digital planimetry or manual linear measurements (e.g. with a ruler), decreases by more than 25% in the 2 weeks prior to the initial screening visit ("historical"...
- The surface area of the target ulcer, as measured by digital planimetry, decreases by more than 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit...
- The potential subject is unable to adhere to therapeutic offloading, if required by anatomical location of target ulce.
- Women who are pregnant or considering becoming pregnant within the next 6 months.
- The potential subject has end stage renal disease requiring dialysis.
- Participation in another clinical trial involving treatment with an investigational product within the previous 30 days.
- A potential subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.
- The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
- The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
- Potential people with a sensitivity or allergy to porcine materials or collagen will be excluded.
- Potential people with religious or personal objection to use of porcine- or animal-derived materials will be excluded.
- A subject with a disorder that would create unacceptable risk of treatment complications is excluded.
- people will be considered ineligible for enrolment if any of the following criteria are met: i. Immune system disorders including Systemic Lupus Erythematosus (SLE), Acquired Immunodeficiency Syndrome (AIDS) or HIV. ii...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Vista, California, United States
- Hialeah, Florida, United States
- Jasper, Indiana, United States
- Hagerstown, Maryland, United States
- Boston, Massachusetts, United States
- New Hyde Park, New York, United States
- Raleigh, North Carolina, 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 Los Angeles, California, United States; San Francisco, California, United States; Vista, California, United States; Hialeah, Florida, United States; Jasper, Indiana, United States; Hagerstown, Maryland, United States and 3 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.