Diabetic Foot UlcersNCT00958711

The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer

A study testing Unite Biomatrix and Saline and Gauze in people with Diabetic Foot Ulcers, run by Baxter Healthcare Corporation at 11 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, saline moistened gauze, for the treatment of diabetic foot ulcers. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Foot Ulcers
What is being tested?: Unite Biomatrix and Saline and Gauze
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 11 sitesUnited States
Study dates: Jan 2009to May 2012
Phase: Interventional
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

A full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on Wagner scale).
Diagnosis of diabetes mellitus (type I or II) adequately controlled.
The ulcer is greater than 4 weeks duration.
Three or fewer ulcers separated by > 3.0 cm distance.
Post-debridement, the ulcer size must be between 1 and 10 sq cm2.
Ankle/brachial index is between 0.7 to 1.2 and or one of the following must be present:

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transcutaneous partial pressure oxygen (TcPO2) > 30 mmHg at the ankle
toe pressure of >40mm Hg or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
At least 18 years old.
Able and willing to provide a voluntary written informed consent.
Able and willing to wear an off-loading orthopedic shoe.
Able and willing to attend scheduled follow-up visits and study related exams.

Who cannot join

Greater than 30% reduction in wound size during first week of observation by the investigator.
Ulcer with exposed tendon or bone.
Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis.
Gangrene.
Active Charcot's disease as determined by clinical and radiographic examination.
Ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers).

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Known severe anemia.
Known serum albumin < 2.5.
Renal failure with Creatinine > 2.5.
Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV.
Severe liver disease as defined by the treating physician or patient's primary care physician.
Malignancy at or near the ulcer site.
Any condition judged by the investigator that would cause the study to be detrimental to the patient.
Presence of a hematology, clinical, chemistry or other test obtained within 7 days of screening that is outside the normal range for the laboratory and is determined to be clinically significant by the investigator.
Received another investigational device or drug within 30 days of Day 0.
Radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment.
Received another allograft, autograft or xenograft within 30 days of the Day 0.
Known allergy to equine derived tissue.
Alcohol or drug abuse, defined as current medical treatment for substance abuse.
Pregnant or nursing women.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Aiyan Diabetes Center
Evans, Georgia, 30809
Eastern Carolina Foot and Ankle
Greenville, North Carolina, 27834
Foot and Ankle East
Greenville, North Carolina, 27834
Carolina East Family Medicine
Greenville, North Carolina, 27858
Family Foot & Ankle Physicians
Greenville, North Carolina, 27858
Comprehensive Wound Care Thoracic & Vascular Associates of Kinston P.A.
Kinston, North Carolina, 28504
University of Miami, Miller School of Medicine
Miami, Florida, 33136
The Foot & Ankle Associates of North Carolina, PLLC
Rocky Mount, North Carolina, 27804
University of California - San Diego
San Diego, California, 92103
Foot & Ankle Associates of Central Illinois, LLC
Springfield, Illinois, 62704
Martin Foot and Ankle
York, Pennsylvania, 17403

Other trials in United States

About this study

Conditions: Diabetic Foot Ulcers
Being tested: Unite Biomatrix, Saline and Gauze
Medical subject headings: Diabetic Foot

What participants receive

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

Unite BiomatrixDevice
Collagen based, decellularized equine pericardial dressing for skin surface wounds
Saline and GauzeOther
gauze moistened with sterile saline

Study groups in NCT00958711
Study group	Role	What they receive
Biologic - Unite Biomatrix	Experimental	Not described Receives: Device: Unite Biomatrix
Saline and Gauze	Active comparator	Not described Receives: Other: Saline and Gauze

What is being measured

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

Percentage of Participants Not Healed by Number of Days After Procedure
Time to complete healing was captured by Kaplan-Meier Plot showing percentage of participants not healed by number of days after procedure. Patients were considered healed at their first follow-up visit where the patient's would had healed.
Measured: Day 20, Day 40, Day 60, Day 80
Percentage of Participants With Wounds Healed at 12 Weeks
Measured: Week 12
Wound Healing Pathway Markers
Measured: Day 0, 72 hours post-procedure, Week 1, Week 2, Week 4
Bacterial Burden
Measured: Day 0, Week 1 - Week 12

Secondary outcomes (7)

Percentage Mean of Original Wound Size From Baseline by Week
The percent of original wound size was calculated using the following formula: measure at baseline minus measure at follow-up visit divided by measure at baseline. In cases when the baseline depth was reported as 0cm, the minimum non-zero value in the sample (0.1cm) was imputed so a percent reduction measure could be calculated.
Measured: Day 0, Week 4, Week 8, Week 12
Number of Participants With Ulcer Recurrence
Measured: Week 1 to Week 24
Number of Device-related Adverse Events (AE)
Measured: Week 1 to Week 24
Number of Procedure-related Adverse Events (AE)
Measured: Week 1 to Week 24
Number of Device Failures
Includes failure to heal the ulcer by the 12-week visit under the Intent-to-Treat principle.
Measured: Week 1 to Week 24
Number of Device Removals
Device removal is included in device failure under ITT. Subjects who experienced procedure-related events were also device failures under ITT. This endpoint is equivalent to device failure rates reported above.
Measured: Week 1 to Week 24
Ease of Dressing Use
Ease of usage on a 5-point scale where 1=greatest ease of use and 5=greatest difficult
Measured: Week 1 to Week 12

Timeline

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

Jan 2009May 2012

First posted13 Aug 2009 (estimated)
Study startJan 2009
Primary completionMay 2012
Study completionMay 2012

Why it stopped: Budgetary

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 UlcersStudies 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
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00958711
Sponsor's protocol ID: U-0801
Status last verified: Dec 2019
First submitted: 11 Aug 2009
Last updated: 18 Dec 2019
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
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

All Diabetic Foot Ulcers trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer
ClinicalTrials.gov ID: NCT00958711
Acronym / sponsor ID: U-0801
Conditions: Diabetic Foot Ulcers
Study type: Interventional
Recruitment status: TerminatedReason stopped: Budgetary
Enrolment: 90 participants (actual)
Lead sponsor: Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
Collaborators: Synovis Surgical Innovations
Study start: Jan 2009
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 13 Aug 2009 (estimated)
Results: Posted 18 Dec 2019

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Biologic - Unite Biomatrix	Experimental	Device: Unite Biomatrix
Saline and Gauze	Active comparator	Other: Saline and Gauze

Who may qualify

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

Key inclusion criteria (12 listed)

A full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on Wagner scale).
Diagnosis of diabetes mellitus (type I or II) adequately controlled.
The ulcer is greater than 4 weeks duration.
Three or fewer ulcers separated by > 3.0 cm distance.
Post-debridement, the ulcer size must be between 1 and 10 sq cm2.

Key exclusion criteria (20 listed)

Greater than 30% reduction in wound size during first week of observation by the investigator.
Ulcer with exposed tendon or bone.
Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis.
Gangrene.
Active Charcot's disease as determined by clinical and radiographic examination.

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
Unite BiomatrixCollagen based, decellularized equine pericardial dressing for skin surface wounds	Device	Biologic - Unite Biomatrix
Saline and Gauzegauze moistened with sterile saline	Other	Saline and Gauze

Primary outcome

Percentage of Participants Not Healed by Number of Days After Procedure
Time frame: Day 20, Day 40, Day 60, Day 80
Time to complete healing was captured by Kaplan-Meier Plot showing percentage of participants not healed by number of days after procedure. Patients were considered healed at their first follow-up visit where the patient's would had healed.
Percentage of Participants With Wounds Healed at 12 Weeks
Time frame: Week 12
Wound Healing Pathway Markers
Time frame: Day 0, 72 hours post-procedure, Week 1, Week 2, Week 4
Bacterial Burden
Time frame: Day 0, Week 1 - Week 12

7 secondary outcomes

Percentage Mean of Original Wound Size From Baseline by Week
Time frame: Day 0, Week 4, Week 8, Week 12
Number of Participants With Ulcer Recurrence
Time frame: Week 1 to Week 24
Number of Device-related Adverse Events (AE)
Time frame: Week 1 to Week 24
Number of Procedure-related Adverse Events (AE)
Time frame: Week 1 to Week 24
Number of Device Failures
Time frame: Week 1 to Week 24
Number of Device Removals
Time frame: Week 1 to Week 24
Ease of Dressing Use
Time frame: Week 1 to Week 12

Results and safety

Results posted to the registry on 18 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Biologic - Unite Biomatrix	42	29
Saline and Gauze	48	27

Primary outcome: Percentage of Participants Not Healed by Number of Days After Procedure

Time frame: Day 20, Day 40, Day 60, Day 80. Number. Unit: Percentage of Participants

Measure	Biologic - Unite Biomatrix n = 42	Saline and Gauze n = 48
Day 20	0.97	1.0
Day 40	0.91	0.95
Day 60	0.74	0.74
Day 80	0.61	0.65

Population analysed: Intent-to-Treat (ITT): all randomized participants who provided consent..

Primary outcome: Percentage of Participants With Wounds Healed at 12 Weeks

Time frame: Week 12. Number. Unit: Percentage of participants

Measure	Biologic - Unite Biomatrix n = 42	Saline and Gauze n = 48
Healed	42.9	29.2
Not Healed	57.1	70.8

Population analysed: ITT

Primary outcome: Wound Healing Pathway Markers

Time frame: Day 0, 72 hours post-procedure, Week 1, Week 2, Week 4

Population analysed: Source document notes "no data provided." Limited information available since product no longer licensed with Baxter.

Primary outcome: Bacterial Burden

Time frame: Day 0, Week 1 - Week 12

Population analysed: Source document notes "no data provided." Limited information available since product no longer licensed with Baxter.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day -12 through Day 180. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Biologic - Unite Biomatrix	9 of 42 (21.4%)	6 of 42 (14.3%)	1 of 42
Saline and Gauze	8 of 48 (16.7%)	7 of 48 (14.6%)	2 of 48

Limitations and caveats (from the sponsor): Study initially sponsored by Synovis Surgical Innovation, and product now licensed with Biomed Design. Unable to obtain all data for study. Clinical Study Report not located and results summarized from an abbreviated Statistical Analysis Report.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Foot Ulcers

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing Unite Biomatrix and Saline and Gauze in people with Diabetic Foot Ulcers, run by Baxter Healthcare Corporation at 11 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 12 inclusion and 20 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: stopped early, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2019). 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?

Percentage of Participants Not Healed by Number of Days After Procedure (time frame: Day 20, Day 40, Day 60, Day 80). The study lists 4 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 NCT00958711.

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 Dec 2019.