Treatment of Wounds Using Oasis® ECM

NCT03632031 | Completed FDA Device

• 1 other identifier: 17-001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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 donor site wounds in the community setting in the United Kingdom.

Conditions

Non-healing Wound

Keywords

partial and full-thickness wounds; pressure ulcer; venous ulcer; chronic vascular ulcer; diabetic ulcer

Outcome Measures

Primary Outcomes (1)

• Wound healing

  To demonstrate the percentage of patients with wounds progressing to at least 50% healing

  12 weeks

Secondary Outcomes (5)

• Wound closure- Percentage

  up to 12 weeks

• Wound closure- Mean number of weeks

  up to 12 weeks

• Wound closure- Mean Percentage

  up to 12 weeks

• Patient reported Quality of Life measurement

  up to 12 weeks

• Adverse Events

  up to 12 weeks

Study Arms (2)

20 patients assigned to the OASIS treatment group

EXPERIMENTAL

After skin graft is taken, OASIS will be applied to the donor site.

Device: Oasis Extracellular Matrix

20 patients assigned to the standard wound care

ACTIVE COMPARATOR

After skin graft is taken, donor site will be treated with standard wound care.

Other: Standard Care (in control arm)

Interventions

Standard Care (in control arm) OTHER

Donor site will be treated with standard care.

20 patients assigned to the standard wound care

Oasis Extracellular Matrix DEVICE

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

20 patients assigned to the OASIS treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Non-healing ulcer (any etiology) present for at least 1 month and treated in the ambulatory clinic or home healthcare setting

You may not qualify if:

• Age \< 18 years
• Unable or unwilling to provide informed consent
• Unable or unwilling to comply with the study follow-up schedule, and procedures
• Simultaneously participating in another investigational drug or device study
• Target wound area is \< 2 cm2 or \> 140 cm2 after baseline debridement
• Target wound has reduced in area by \> 40% with 4 weeks of documented standard of care therapy
• Known allergy to pig or porcine products
• Systemic infection
• Infection of the target wound as determined by the collection of pus
• Osteomyelitis
• ABI/TBI \< 0.6 obtained within 3 months prior to the screening visit

Sponsors & Collaborators

• Cook Biotech Incorporated: lead

Study Sites (2)

Nursery Park Health Centre

Ashington, United Kingdom

Location

Pinderfields Hospital

Wakefield, United Kingdom

Location

MeSH Terms

Conditions

Pressure Ulcer; Varicose Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Leanne Atkin, PhD

  Mid Yorkshire Teaching NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A patient is suitable for inclusion in the study if the patient meets the following criteria, based on known information at the time of enrolment: 1\. Non-healing ulcer (any etiology) present for at least 1 month and treated in the ambulatory clinic or home healthcare setting

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 15, 2018
• Study Start: March 1, 2021
• Primary Completion: March 1, 2025
• Study Completion: September 26, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)