INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorConvaTec Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects must be at least 21 years of age or older.
At randomization subjects 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.
Disqualifiers
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.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
InnovaMatrix® AC
DeviceWeekly dressing applications
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: Standard of Care plus Interventional DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Determine the efficacy of Porcine Placental Extracellular Matrix (PPECM) plus Standard of Care (SOC) versus SOC alone in achieving complete closure of hard-to-heal venous leg ulcers over 12 weeks.
The percentage of target ulcers achieving complete wound closure defined as complete epithelialisation of the wound surface.
Time frame
12 weeksSecondary outcomes
1
Determine the time to closure for ulcers achieving complete closure over 12-weeks for PPECM+SOC versus SOC alone.
For study ulcers achieving complete closure, the time to closure over the 12-week treatment duration.
Time frame
12 weeks2
Determine the percent area reduction (PAR) of the ulcer over the 12-week treatment period.
Percentage wound area reduction from initial treatment to 12-week measured weekly with digital photographic planimetry.
Time frame
12 weeks3
Determine quality of life (QoL) for subjects receiving PPECM+SOC compared to SOC alone.
Measured with Forgotten Wound Score (FWS) questionnaire, assessing the awareness of the wound, ranging from "Never" to "Mostly").
Time frame
Day 0, 4 weeks, 8 weeks, and 12 weeks4
Determine quality of life (QoL) for subjects receiving PPECM+SOC compared to SOC alone.
Measured with standard Wound Quality of Life (wQOL) questionnaire, assessing how wound care has affected the quality of life in the last seven days, ranging from "Not at all" to "Very much".
Time frame
Day 0, 4 weeks, 8 weeks, and 12 weeksOther outcomes
1
Number of serious adverse events (SAE).
Number of events related to the device, procedure, or target study ulcer.
Time frame
12 month2
Number of study-ulcer infections.
Infections for PPECM+SOC vs SOC alone.
Time frame
12 monthSponsors and contacts
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Source ClinicalTrials.gov