Treatment of Wounds Using Oasis® ECM

Completed

• Conditions: Non-healing Wound
• Interventions: Device: Oasis Extracellular Matrix

• Registration Number: NCT03632031
• Lead Sponsor: Cook Biotech Incorporated

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 different types of chronic wounds in the community setting in the United Kingdom.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Study Start: 2018-09-26
• Primary Completion: 2019-11-13
• Study Completion: 2020-01-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic non-healing wounds	Oasis Extracellular Matrix	Patients with chronic non-healing wounds with planned use of OASIS Extracellular Wound Matrix

Primary Outcome Measures

Name	Time	Method
Wound healing	12 weeks	To demonstrate the percentage of patients with wounds progressing to at least 50% healing

Secondary Outcome Measures

Name	Time	Method
Wound closure- Percentage	up to 12 weeks	Percentage of patients with complete wound closure
Wound closure- Mean Percentage	up to 12 weeks	Mean percent wound closure
Wound closure- Mean number of weeks	up to 12 weeks	mean number of weeks to complete 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

Trial Locations

Locations (2)

Pinderfields Hospital; 🇬🇧 Wakefield, United Kingdom

Nursery Park Health Centre; 🇬🇧 Ashington, United Kingdom