Treatment of Wounds Using Oasis® ECM

Non-healing Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03632031
• Other study ID #: 17-001
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Non-healing Wound
• Wounds and Injuries

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