Non-healing Wound Clinical Trial
Official title:
Treatment of Wounds Using Oasis® Extracellular Matrix in the Community Setting
NCT number | NCT03632031 |
Other study ID # | 17-001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 26, 2018 |
Est. completion date | January 14, 2020 |
Verified date | July 2021 |
Source | Cook Biotech Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 14, 2020 |
Est. primary completion date | November 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nursery Park Health Centre | Ashington | |
United Kingdom | Pinderfields Hospital | Wakefield |
Lead Sponsor | Collaborator |
---|---|
Cook Biotech Incorporated |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound healing | To demonstrate the percentage of patients with wounds progressing to at least 50% healing | 12 weeks | |
Secondary | Wound closure- Percentage | Percentage of patients with complete wound closure | up to 12 weeks | |
Secondary | Wound closure- Mean number of weeks | mean number of weeks to complete wound closure | up to 12 weeks | |
Secondary | Wound closure- Mean Percentage | Mean percent wound closure | up to 12 weeks | |
Secondary | 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 | |
Secondary | Adverse Events | Summary of adverse events reported | up to 12 weeks |
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