Ulcer Venous, Wound Heal
Conditions
Brief summary
The study is a multi-center, prospective, clinical trial designed to evaluate the use of InnovaMatrix AC sterilized porcine placental ECM to treat chronic VLUs . The trial will include 30 completed subjects at multiple, experienced clinical centers in the United States.
Interventions
DEVICEInnovaMatrix® AC Sterilized, Porcine Placental Extracellular Matrix (ECM)
weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and compression therapy
Sponsors
ConvaTec Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients over 18 years of age who have given written informed consent in accordance with the ICH Good Clinical Practice (GCP) guideline. Female subjects must be either of non-childbearing potential or if of childbearing potential must satisfy the defined contraceptive criteria
Exclusion criteria
. 2. Patients who are willing and able to attend all follow-up visits. 3. Index ulcer characteristics: 1. Ulcer present for ≥ 30 days prior to (Day 0). 2. Index ulcer is above the malleolus. 3. Ulcer greater than or equal to 2cm2 and less than or equal to 20cm2 at the time of enrollment. 4. Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following within the past 30 days: * Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, Or * ABIs with results of ≥ 0.7 and ≤ 1.2, Or * Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot. For ABPI \>1.2 TBI (Toe Brachial Index) \> 0.5. * Patient able to ambulate at home or in the clinic with or without mobility aids. 5. The subject is willing to accept treatment with a porcine based product and to undergo weekly compression wrapping. 6. The subject is medically stable, in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Area | 12 Weeks | Assessment of ulcer area (percent area reduction from baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of wound closure | 12 Weeks | Rate of wound closure as assessed by wound area measurements determined by weekly percent area reduction. |
| Time to complete wound closure | 12 Weeks | Time to complete wound closure as defined by FDA. |
| Adverse Events | 12 Weeks | Incidence of adverse events |
| Reduction in pain | 12 Weeks | Assessment of the pain level linked to the wound, using the validated PEG pain scale (0-10), with a higher score indicating more severe pain and pain-related interference with life and activities. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bacterial Burden | 12 Weeks | Reduction in bacterial burden as assessed by fluorescence imaging and polymerase chain reaction (PCR). |
| App Usability | End of Study | Assess ease of device using SUS questionnaire for WoundAlert smartphone application. To be completed by subject and provider The SUS scoring rule is as follows: (1) based on the level, each problem has a base score that ranges from 1-5, which corresponds to the range from strongly disagree to strongly agree; (2) the scores for questions 1, 3, 5, 7, and 9 are equal to the base score minus 1; the scores for questions 2, 4, 6, 8, and 10 are equal to five minus the base score; (3) the scores of the ten questions are added to obtain the total score of the questionnaire; and the questionnaire SUS score is the total score times 2.5. The SUS is represented as a percentage. |
| Patient compliance with recommendations | 12 Weeks | Patient compliance with behavioral treatment recommendations for the healing of venous leg ulceration. Treatment recomendations defined as multilayer compression therapy (as supplied by SerenaGroup®), with weekly assessments of effectiveness of multilayer compression with patient compliance. |
Countries
United States
Outcome results
None listed