RECRUITING

INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-09-19

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06606210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	1. The potential subject is known to have a life expectancy of \< 6 months. 2. 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. 3. The target ulcer exposes tendon or bone. 4. There is evidence of osteomyelitis complicating the target ulcer. 5. 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 Principal Investigator believes will interfere with wound healing (e.g., biologics). 6. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening. 7. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit. 8. 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 during the historical run-in period (e.g., calculating surface area using length X width is acceptable). 9. 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 subject received SOC. 10. The potential subject has had a lower extremity Deep Vein Thrombosis (DVT) to either limb within the previous 90 days. 11. The potential subject is unable to tolerate therapeutic compression (30-40mmHg). 12. Women who are pregnant or considering becoming pregnant within the next 6 months. 13. The potential subject has end stage renal disease requiring dialysis. 14. Participation in another clinical trial involving treatment with an investigational product within the previous 30 days. 15. A potential subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments. 16. 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. 17. The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment. 18. Potential subjects with a sensitivity or allergy to porcine materials or collagen. 19. Potential subjects with religious or personal objection to use of porcine- or animal-derived materials. 20. A subject with a disorder that would create unacceptable risk of treatment complications.

Inclusion Criteria

Exclusion 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.

1. The potential subject is known to have a life expectancy of \< 6 months.
2. 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.
3. The target ulcer exposes tendon or bone.
4. There is evidence of osteomyelitis complicating the target ulcer.
5. 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 Principal Investigator believes will interfere with wound healing (e.g., biologics).
6. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
7. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
8. 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 during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
9. 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 subject received SOC.
10. The potential subject has had a lower extremity Deep Vein Thrombosis (DVT) to either limb within the previous 90 days.
11. The potential subject is unable to tolerate therapeutic compression (30-40mmHg).
12. Women who are pregnant or considering becoming pregnant within the next 6 months.
13. The potential subject has end stage renal disease requiring dialysis.
14. Participation in another clinical trial involving treatment with an investigational product within the previous 30 days.
15. A potential subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.
16. 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.
17. The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
18. Potential subjects with a sensitivity or allergy to porcine materials or collagen.
19. Potential subjects with religious or personal objection to use of porcine- or animal-derived materials.
20. A subject with a disorder that would create unacceptable risk of treatment complications.

Contacts and Locations

Study Contact

Andrea Picchietti

CONTACT

727-247-5234

andrea.picchietti@convatec.com

Principal Investigator

Thomas E. Serena, MD FACS

PRINCIPAL_INVESTIGATOR

SerenaGroup, Inc.

Study Locations (Sites)

Three Rivers Wound and Hyperbaric Center

North Port, Florida, 34289

United States

Collaborators and Investigators

Sponsor: ConvaTec Inc.

Thomas E. Serena, MD FACS, PRINCIPAL_INVESTIGATOR, SerenaGroup, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-19

Study Completion Date2026-04

Study Record Updates

Study Start Date2024-09-19

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Wound Heal
Venous Leg Ulcer