Treatment of Wounds Using Oasis® ECM

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

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.

Study Overview

• Status: Completed
• Conditions: Non-healing Wound
• Intervention / Treatment: Device: Oasis Extracellular Matrix; Other: Standard Care (in control arm)

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Ashington, United Kingdom
    • Nursery Park Health Centre
  • Wakefield, United Kingdom
    • Pinderfields Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Patients with non-healing ulcer (any etiology) present for at least 1 month and treated in the ambulatory clinic or home healthcare setting

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20 patients assigned to the OASIS treatment group; After skin graft is taken, OASIS will be applied to the donor site.	Device: Oasis Extracellular Matrix; Patients will receive OASIS Extracellular Matrix according to the Instruction for Use
Active Comparator: 20 patients assigned to the standard wound care; After skin graft is taken, donor site will be treated with standard wound care.	Other: Standard Care (in control arm); Donor site will be treated with standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing	To demonstrate the percentage of patients with wounds progressing to at least 50% healing	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound closure- Percentage	Percentage of patients with complete wound closure	up to 12 weeks
Wound closure- Mean number of weeks	mean number of weeks to complete wound closure	up to 12 weeks
Wound closure- Mean Percentage	Mean percent wound closure	up to 12 weeks
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
Adverse Events	Summary of adverse events reported	up to 12 weeks

Collaborators and Investigators

• Sponsor: Cook Biotech Incorporated
• Investigators: Principal Investigator: Leanne Atkin, PhD, Mid Yorkshire Teaching NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): September 26, 2025

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: pressure ulcer; diabetic ulcer; partial and full-thickness wounds; venous ulcer; chronic vascular ulcer
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Skin and Connective Tissue Diseases; Varicose Ulcer; Pressure Ulcer; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 17-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes