Non-healing Wound
Conditions
Keywords
partial and full-thickness wounds, pressure ulcer, venous ulcer, chronic vascular ulcer, diabetic ulcer
Brief summary
The purpose of this clinical study is to gather post-market clinical evidence on the use of Oasis ECM as a treatment for donor site wounds in the community setting in the United Kingdom.
Detailed description
This prospective randomized controlled clinical study is being performed to evaluate the safety and performance of OASIS Extracellular Matrix when used as a treatment for donor site wounds as compared to standard wound care. This study will consent and treat up to 40 patients with 20 patients assigned to the OASIS treatment group and 20 patients assigned to the standard wound care treatment group.
Interventions
DEVICEOasis Extracellular Matrix
Patients will receive OASIS Extracellular Matrix according to the Instruction for Use
OTHERStandard Care (in control arm)
Donor site will be treated with standard care.
Sponsors
Cook Biotech Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A patient is suitable for inclusion in the study if the patient meets the following criteria, based on known information at the time of enrolment: 1\. Non-healing ulcer (any etiology) present for at least 1 month and treated in the ambulatory clinic or home healthcare setting
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
1. Age \< 18 years 2. Unable or unwilling to provide informed consent 3. Unable or unwilling to comply with the study follow-up schedule, and procedures 4. Simultaneously participating in another investigational drug or device study 5. Target wound area is \< 2 cm2 or \> 140 cm2 after baseline debridement 6. Target wound has reduced in area by \> 40% with 4 weeks of documented standard of care therapy 7. Known allergy to pig or porcine products 8. Systemic infection 9. Infection of the target wound as determined by the collection of pus 10. Osteomyelitis 11. ABI/TBI \< 0.6 obtained within 3 months prior to the screening visit 12. Other exclusions may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing | 12 weeks | To demonstrate the percentage of patients with wounds progressing to at least 50% healing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound closure- Percentage | up to 12 weeks | Percentage of patients with complete wound closure |
| Wound closure- Mean number of weeks | up to 12 weeks | mean number of weeks to complete wound closure |
| Wound closure- Mean Percentage | up to 12 weeks | Mean percent wound closure |
| Patient reported Quality of Life measurement | up to 12 weeks | 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. |
| Adverse Events | up to 12 weeks | Summary of adverse events reported |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORLeanne Atkin, PhD
Mid Yorkshire Teaching NHS Trust
Outcome results
None listed