Non-healing WoundNCT03632031
Treatment of Wounds Using Oasis® ECM
A study testing Oasis Extracellular Matrix in people with Non-healing Wound, run by Cook Biotech Incorporated at 2 sites in United Kingdom.
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 donor site wounds in the community setting in the United Kingdom. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-healing Wound
- What is being tested?
- Oasis Extracellular Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Mar 2021to 26 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Non-healing ulcer (any etiology) present for at least 1 month and treated in the ambulatory clinic or home healthcare setting
Who cannot join
- 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
Show all 12Show fewer
- 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
- Other exclusions may apply
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Nursery Park Health Centre
Ashington
Pinderfields Hospital
Wakefield
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-healing Wound
- Being tested
- Oasis Extracellular Matrix, Standard Care (in control arm)
- Keywords
- partial and full-thickness wounds, pressure ulcer, venous ulcer, chronic vascular ulcer, diabetic ulcer
- Medical subject headings
- Pressure Ulcer, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oasis Extracellular MatrixDevice
Patients will receive OASIS Extracellular Matrix according to the Instruction for Use
Standard Care (in control arm)Other
Donor site will be treated with standard care.
| Study group | Role | What they receive |
|---|---|---|
| 20 patients assigned to the OASIS treatment group | Experimental | After skin graft is taken, OASIS will be applied to the donor site. Receives: 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. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
To demonstrate the percentage of patients with wounds progressing to at least 50% healing
Measured: 12 weeks
Secondary outcomes (5)
Wound closure- Percentage
Percentage of patients with complete wound closure
Measured: up to 12 weeks
Wound closure- Mean number of weeks
mean number of weeks to complete wound closure
Measured: up to 12 weeks
Wound closure- Mean Percentage
Mean percent wound closure
Measured: 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.
Measured: up to 12 weeks
Adverse Events
Summary of adverse events reported
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Mar 2021
- Primary completion1 Mar 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-healing WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Biotech Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leanne Atkin, PhD, Principal investigator, Mid Yorkshire Teaching NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632031
- Sponsor's protocol ID
- 17-001
- Status last verified
- Feb 2026
- First submitted
- 13 Aug 2018
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Wounds Using Oasis® Extracellular Matrix in the Community Setting
- ClinicalTrials.gov ID
- NCT03632031
- Acronym / sponsor ID
- 17-001
- Conditions
- Non-healing Wound
- Keywords
- partial and full-thickness wounds, pressure ulcer, venous ulcer, chronic vascular ulcer, diabetic ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Cook Biotech IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 20 patients assigned to the OASIS treatment group | Experimental | Device: Oasis Extracellular MatrixAfter skin graft is taken, OASIS will be applied to the donor site. |
| 20 patients assigned to the standard wound care | Active comparator | Other: Standard Care (in control arm)After skin graft is taken, donor site will be treated with standard wound care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Non-healing ulcer (any etiology) present for at least 1 month and treated in the ambulatory clinic or home healthcare setting
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oasis Extracellular MatrixPatients will receive OASIS Extracellular Matrix according to the Instruction for Use | Device | 20 patients assigned to the OASIS treatment group |
| Standard Care (in control arm)Donor site will be treated with standard care. | Other | 20 patients assigned to the standard wound care |
Primary outcome
Wound healing
Time frame: 12 weeks
To demonstrate the percentage of patients with wounds progressing to at least 50% healing
5 secondary outcomes
Wound closure- Percentage
Time frame: up to 12 weeks
Wound closure- Mean number of weeks
Time frame: up to 12 weeks
Wound closure- Mean Percentage
Time frame: up to 12 weeks
Patient reported Quality of Life measurement
Time frame: up to 12 weeks
Adverse Events
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leanne Atkin, PhD principal investigator
Mid Yorkshire Teaching NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oasis Extracellular Matrix in people with Non-healing Wound, run by Cook Biotech Incorporated at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.