Treatment of Wounds Using Oasis® ECM

Study Overview
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Brief Summary
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The purpose of this clinical study is to gather post-market clinical evidence on the use of Oasis ECM as a treatment for different types of chronic wounds in the community setting in the United Kingdom.

Official Title
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Treatment of Wounds Using Oasis® Extracellular Matrix in the Community Setting

Conditions
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Non-healing Wound

Intervention / Treatment
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* Device: Oasis Extracellular Matrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Non-healing ulcer (any etiology) present for at least 1 month and treated in the ambulatory clinic or home healthcare setting Exclusion Criteria: Age < 18 years Unable or unwilling to provide informed consent Unable or unwilling to comply with the study follow-up schedule, and procedures Simultaneously participating in another investigational drug or device study Target wound area is < 2 cm2 or > 140 cm2 after baseline debridement Target wound has reduced in area by > 40% with 4 weeks of documented standard of care therapy Known allergy to pig or porcine products Systemic infection Infection of the target wound as determined by the collection of pus Osteomyelitis ABI/TBI < 0.6 obtained within 3 months prior to the screening visit Other exclusions may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with chronic non-healing wounds<br>Patients with chronic non-healing wounds with planned use of OASIS Extracellular Wound Matrix | Device: Oasis Extracellular Matrix<br>* Patients will receive OASIS Extracellular Matrix according to the Instruction for Use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | To demonstrate the percentage of patients with wounds progressing to at least 50% healing | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound closure- Percentage | Percentage of patients with complete wound closure | up to 12 weeks | 
| Wound closure- Mean number of weeks | mean number of weeks to complete wound closure | up to 12 weeks | 
| Wound closure- Mean Percentage | Mean percent wound closure | up to 12 weeks | 
| Patient reported Quality of Life measurement | The Wound Quality of Life (QoL) questionnaire is used for measurement of Health-Related Quality of Life in patients with chronic wounds. The total value of this measurement is derived from an average of 17 questions; each question has a value of a minimum of 1 and a maximum of 5. The lower the score, the better the outcome. Subscales are not combined to compute a total score. | up to 12 weeks | 
| Adverse Events | Summary of adverse events reported | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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partial and full-thickness wounds, pressure ulcer, venous ulcer, chronic vascular ulcer, diabetic ulcer