Diabetic Foot Ulcers (DFU)Phase 4NCT00570141

OASIS Wound Matrix (Oasis) Mechanism of Action

A Phase 4 study testing OASIS Wound Matrix in people with Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU), run by Healthpoint at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Foot Ulcers (DFU), Venous Stasis Ulcers (VSU)
What is being tested?: OASIS Wound Matrix
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 3 sitesUnited States
Study dates: Oct 2007to Apr 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Diabetic foot ulcer (DFU) or venous stasis ulcer (VSU) of the leg, with certain restrictions on size, duration and underlying health

Who cannot join

Contraindications or hypersensitivity to the use of the study medications or their components

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Sparks Regional Medical Center
Fort Smith, Arkansas, 72901
Bay Pines VA Healthcare System
St Louis, Missouri
Dixie Regional Medical Center Wound Clinic
St. George, Utah, 84770

Other trials in United States

About this study

Official title: Case Study Documentation of Subjects With Either Diabetic Foot Ulcers or Venous Stasis Ulcers Being Treated With OASIS

OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.

Read the detailed description

Wound types will be Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).

Conditions: Diabetic Foot Ulcers (DFU), Venous Stasis Ulcers (VSU)
Being tested: OASIS Wound Matrix
Medical subject headings: Diabetic Foot, Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OASIS Wound MatrixDevice
OASIS (an acellular biomaterial that supports tissue repair with a scaffold-like matrix having a natural structure and composition).

Study groups in NCT00570141
Study group	Role	What they receive
OASIS Wound Matrix (Oasis)	Active comparator	This is a single arm study with only the test article Oasis used on all subjects Receives: Device: OASIS Wound Matrix

What is being measured

The primary outcome is the main question the study is designed to answer.

Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First.
Wound measurements were made weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first.
The final measurement taken was subtracted from the baseline to assess the decrease in wound area after treatment.
Final calculation is mean baseline measurement minus final measurement at 12 weeks (or when wound healed, whichever occurred first)
Measured: Baseline and weekly up to 12 weeks
Percent Wounds Closed
Wound healing was assessed weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first.
The outcome value was based on the percent of wounds which were closed at the end of the study (at 12 weeks). The percent wounds closed were calculated for each wound type: Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).
Measured: baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Apr 2010

First posted10 Dec 2007 (estimated)
Study startOct 2007
Primary completionApr 2009
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Foot Ulcers (DFU)Studies 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 4
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00570141
Sponsor's protocol ID: 9310-002-004
Status last verified: Jun 2011
First submitted: 6 Dec 2007
Last updated: 9 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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PAW-Hydrogel for Chronic Wound Healing
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DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
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Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
Recruiting
Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Diabetic Foot Ulcer, Foot Ulcer Chronic
Active, not recruiting
Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers
Diabetic Foot Ulcer (DFU)

All Diabetic Foot Ulcers (DFU) trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Case Study Documentation of Subjects With Either Diabetic Foot Ulcers or Venous Stasis Ulcers Being Treated With OASIS
ClinicalTrials.gov ID: NCT00570141
Acronym / sponsor ID: 9310-002-004
Conditions: Diabetic Foot Ulcers (DFU), Venous Stasis Ulcers (VSU)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: HealthpointIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Apr 2009 (actual)
Study completion: Apr 2010 (actual)
First posted: 10 Dec 2007 (estimated)
Results: Posted 9 Aug 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.

Detailed description

Wound types will be Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).

Study design

Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OASIS Wound Matrix (Oasis)	Active comparator	Device: OASIS Wound MatrixThis is a single arm study with only the test article Oasis used on all subjects

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Diabetic foot ulcer (DFU) or venous stasis ulcer (VSU) of the leg, with certain restrictions on size, duration and underlying health

Key exclusion criteria (1 listed)

Contraindications or hypersensitivity to the use of the study medications or their components

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 Wound MatrixOASIS (an acellular biomaterial that supports tissue repair with a scaffold-like matrix having a natural structure and composition).	Device	OASIS Wound Matrix (Oasis)

Primary outcome

Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First.
Time frame: Baseline and weekly up to 12 weeks
Wound measurements were made weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first. The final measurement taken was subtracted from the baseline to assess the decrease in wound area after treatment. Final calculation is mean baseline measurement minus final measurement at 12 weeks (or when wound healed, whichever occurred first)
Percent Wounds Closed
Time frame: baseline and 12 weeks
Wound healing was assessed weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first. The outcome value was based on the percent of wounds which were closed at the end of the study (at 12 weeks). The percent wounds closed were calculated for each wound type: Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).

Results and safety

Results posted to the registry on 9 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OASIS Wound Matrix (Oasis)	13	10

Primary outcome: Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First.

Time frame: Baseline and weekly up to 12 weeks. Mean (Standard Deviation). Unit: cm2

Measure	OASIS Wound Matrix (Oasis) n = 13
Diabetic Foot Ulcers (DFU)	1.3 (0.6)
Venous Stasis Ulcers (VSU)	3.6 (2.2)

Population analysed: Analysis was Per Protocol

Primary outcome: Percent Wounds Closed

Time frame: baseline and 12 weeks. Number. Unit: Percent of Wounds Closed

Measure	OASIS Wound Matrix (Oasis) n = 13
Diabetic Foot Ulcers (DFU)	50.0
Venous Stasis Ulcers (VSU)	66.7

Population analysed: Analysis was Per Protocol

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OASIS Wound Matrix (Oasis)	0 of 13 (0%)	6 of 13 (46.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Foot Ulcers (DFU)

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Recruiting
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
Recruiting
Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Diabetic Foot Ulcer, Foot Ulcer Chronic
Active, not recruiting
Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers
Diabetic Foot Ulcer (DFU)

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.

W. Payne, M.D. principal investigator

Bay Pines VA Healthcare System

Carl Van Gils, DPM, CWS principal investigator

Dixie Regional Medical Center Wound Clinic

Davin Haraway, DO principal investigator

Sparks Regional Medical Center

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing OASIS Wound Matrix in people with Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU), run by Healthpoint at 3 sites in United States.

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 1 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 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First. (time frame: Baseline and weekly up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00570141.

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 9 Jun 2011.