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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2021
Source Cook Biotech Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Oasis Extracellular Matrix
Patients will receive OASIS Extracellular Matrix according to the Instruction for Use

Locations

Country Name City State
United Kingdom Nursery Park Health Centre Ashington
United Kingdom Pinderfields Hospital Wakefield

Sponsors (1)

Lead Sponsor Collaborator
Cook Biotech Incorporated

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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