Venous Leg Ulcer, Wound Heal
Conditions
Brief summary
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).
Detailed description
An Observer-Blinded Multicenter Randomized Controlled Trial Evaluating Porcine Placental Extracellular Matrix as an Adjunct to Standard of Care versus Standard of Care Alone in Hard-to-Heal Venous Leg Ulcers.
Interventions
DEVICEInnovaMatrix® AC
Weekly dressing applications
Sponsors
ConvaTec Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must be at least 21 years of age or older. 2. 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. 3. 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. 4. 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. 5. 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: 1. ABI between 0.7 and ≤ 1.3; 2. TBI ≥ 0.6; 3. TCOM ≥ 40 mmHg; 4. PVR: biphasic. 6. 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
Exclusion criteria
will be designated as the target ulcer. 7. The potential subject must agree to attend the weekly study visits required by the protocol. 8. The potential subject must be willing and able to participate in the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 weeks | The percentage of target ulcers achieving complete wound closure defined as complete epithelialisation of the wound surface. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the time to closure for ulcers achieving complete closure over 12-weeks for PPECM+SOC versus SOC alone. | 12 weeks | For study ulcers achieving complete closure, the time to closure over the 12-week treatment duration. |
| Determine the percent area reduction (PAR) of the ulcer over the 12-week treatment period. | 12 weeks | Percentage wound area reduction from initial treatment to 12-week measured weekly with digital photographic planimetry. |
| Determine quality of life (QoL) for subjects receiving PPECM+SOC compared to SOC alone. | Day 0, 4 weeks, 8 weeks, and 12 weeks | Measured with Forgotten Wound Score (FWS) questionnaire, assessing the awareness of the wound, ranging from Never to Mostly). |
| Determine the long-term durability of closure in PPECM+SOC versus SOC alone. | 3-, 6-, 9-, and 12-months after wound closure or completion of the initial 12-week treatment phase | Change in quality of life using the 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of serious adverse events (SAE). | 12 month | Number of events related to the device, procedure, or target study ulcer. |
| Number of study-ulcer infections. | 12 month | Infections for PPECM+SOC vs SOC alone. |
Countries
United States
Contacts
Primary ContactAndrea Picchietti
Outcome results
None listed