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Compares treatment options for Wound Heal
Official title INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone
ClinicalTrials.gov ID: NCT06606210
What this study is testing
- What it's testing
- INNOVEN is a multi-center randomized controlled clinical trial to evaluate the efficacy of porcine placental extracellular matrix (PPECM) and standard of care (SOC) versus SOC alone in the closure of non-healing venous leg ulcers (VLUs).
- 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 21 and older
You may be able to join if
- people must be at least 21 years of age or older.
- At randomization people must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 25 cm2 measured post-debridement.
- The target ulcer must have been present for a minimum of 4 weeks and cannot have received more than 52 weeks of high-level compression prior to the...
- No visible signs of improvement in the four weeks prior to randomization: less than 40% reduction in wound size over the 4 weeks prior to...
- The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first...
You likely can't join if
- will be designated as the target ulcer.
- The potential subject must agree to attend the weekly study visits required by the protocol.
- The potential subject must be willing and able to participate in the informed consent process. Exclusion Criteria:
- The potential subject is known to have a life expectancy of \< 6 months.
- The target ulcer exhibits signs or symptoms consistent with clinical infection, requiring topical antibiotic or antimicrobial agents or systemic...
- The target ulcer exposes tendon or bone.
See the full eligibility criteria
Who can join
- people must be at least 21 years of age or older.
- At randomization people must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 25 cm2 measured post-debridement.
- The target ulcer must have been present for a minimum of 4 weeks and cannot have received more than 52 weeks of high-level compression prior to the initial screening visit.
- No visible signs of improvement in the four weeks prior to randomization: less than 40% reduction in wound size over the 4 weeks prior to randomization.
- The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
- ABI between 0.7 and ≤ 1.3;
- TBI ≥ 0.6;
- TCOM ≥ 40 mmHg;
- PVR: biphasic.
- If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and
What rules you out
- will be designated as the target ulcer.
- The potential subject must agree to attend the weekly study visits required by the protocol.
- The potential subject must be willing and able to participate in the informed consent process. Exclusion Criteria:
- The potential subject is known to have a life expectancy of \< 6 months.
- The target ulcer exhibits signs or symptoms consistent with clinical infection, requiring topical antibiotic or antimicrobial agents or systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
- The target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the target ulcer.
- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the...
- 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 has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Digital planimetry is not required for measurements taken...
- The surface area measurement of the target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential...
- The potential subject has had a lower extremity Deep Vein Thrombosis (DVT) to either limb within the previous 90 days.
- The potential subject is unable to tolerate therapeutic compression (30-40mmHg).
- 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.
- Potential people with religious or personal objection to use of porcine- or animal-derived materials.
- A subject with a disorder that would create unacceptable risk of treatment complications.
The study team makes the final eligibility decision.
Where it's taking place
- North Port, Florida, 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, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include North Port, Florida, United States. 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.