TerminatedNCT00958711Updated Dec 18, 2019Results posted

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

An interventional study of Unite Biomatrix and Saline and Gauze in Diabetic Foot Ulcers, sponsored by Baxter Healthcare Corporation. Terminated at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-18.

Sponsored by Baxter Healthcare Corporation · Not applicable, Interventional, and Treatment

Why this study was terminated

Budgetary

Phase: Not applicable
Study type: Interventional
Enrollment: 90
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Diabetic Foot Ulcers

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Diabetic Foot 1,077

In context

Diabetic Foot

1,077 studies on the registry are indexed under Diabetic Foot; 224 are open to participants now.

This study's enrollment of 90 is above the median of 60 across 845 interventional studies indexed under Diabetic Foot.

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Lead sponsor

Baxter Healthcare Corporation is the lead sponsor of 80 studies on the registry; 1 is open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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:
- 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.

Exclusion criteria

Exclusion Criteria:

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).
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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 90 participants (actual)

Study arms

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

Interventions

DeviceUnite Biomatrix
Collagen based, decellularized equine pericardial dressing for skin surface wounds
OtherSaline and Gauze
gauze moistened with sterile saline

What researchers measure

Primary outcomes

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.
Time frame: Day 20, Day 40, Day 60, Day 80
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

Secondary outcomes

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.
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
Includes failure to heal the ulcer by the 12-week visit under the Intent-to-Treat principle.
Time frame: 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.
Time frame: 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
Time frame: Week 1 to Week 12

Results

Posted Dec 18, 2019

Limitations and caveats

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.

Participant flow

Participant flow — Overall Study
Milestone	Biologic - Unite Biomatrix	Saline and Gauze
Started	42	48
Completed	29	27
Not completed	13	21
Withdrew: Withdrawal by subject	0	4
Withdrew: Physician decision	5	7
Withdrew: Lost to follow-up	4	1
Withdrew: Other	2	5
Withdrew: Death	1	2
Withdrew: Adverse event	1	2

Outcome measures

PrimaryPercentage 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.

Time frame:: Day 20, Day 40, Day 60, Day 80
Reported as:: Number · Percentage of Participants

Percentage of Participants Not Healed by Number of Days After Procedure
Percentage of Participants	Biologic - Unite Biomatrix	Saline and Gauze
Day 20	0.97	1.0
Day 40	0.91	0.95
Day 60	0.74	0.74
Day 80	0.61	0.65

PrimaryPercentage of Participants With Wounds Healed at 12 Weeks

Time frame:: Week 12
Reported as:: Number · Percentage of participants

Percentage of Participants With Wounds Healed at 12 Weeks
Percentage of participants	Biologic - Unite Biomatrix	Saline and Gauze
Healed	42.9	29.2
Not Healed	57.1	70.8

PrimaryWound Healing Pathway Markers

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

No measurements were reported for this outcome.

PrimaryBacterial Burden

Time frame:: Day 0, Week 1 - Week 12

No measurements were reported for this outcome.

SecondaryPercentage 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.

Time frame:: Day 0, Week 4, Week 8, Week 12
Reported as:: Mean · Percentage mean of wound size

Percentage Mean of Original Wound Size From Baseline by Week
Percentage mean of wound size	Biologic - Unite Biomatrix	Saline and Gauze
Week 4 Length	0.879 ± NA	0.754 ± NA
Week 4 Width	0.809 ± NA	0.750 ± NA
Week 4 Depth	0.820 ± NA	1.082 ± NA
Week 4 Area	0.807 ± NA	0.732 ± NA
Week 8 Length	0.705 ± NA	0.695 ± NA
Week 8 Width	0.650 ± NA	0.671 ± NA
Week 8 Depth	1.612 ± NA	1.365 ± NA
Week 8 Area	0.546 ± NA	0.592 ± NA
Week 12 Length	0.381 ± NA	0.567 ± NA
Week 12 Width	0.323 ± NA	0.465 ± NA
Week 12 Depth	0.304 ± NA	1.347 ± NA
Week 12 Area	0.341 ± NA	0.433 ± NA

SecondaryNumber of Participants With Ulcer Recurrence

Time frame:: Week 1 to Week 24
Reported as:: Count of participants · Participants

Number of Participants With Ulcer Recurrence
Participants	Biologic - Unite Biomatrix	Saline and Gauze
Number of Participants With Ulcer Recurrence	0	2

SecondaryNumber of Device-related Adverse Events (AE)

Time frame:: Week 1 to Week 24
Reported as:: Number · Events

Number of Device-related Adverse Events (AE)
Events	Biologic - Unite Biomatrix	Saline and Gauze
Number of Device-related Adverse Events (AE)	0	0

SecondaryNumber of Procedure-related Adverse Events (AE)

Time frame:: Week 1 to Week 24
Reported as:: Number · Events

Number of Procedure-related Adverse Events (AE)
Events	Biologic - Unite Biomatrix	Saline and Gauze
Number of Procedure-related Adverse Events (AE)	2	0

SecondaryNumber of Device Failures

Includes failure to heal the ulcer by the 12-week visit under the Intent-to-Treat principle.

Time frame:: Week 1 to Week 24
Reported as:: Number · Devices

Number of Device Failures
Devices	Biologic - Unite Biomatrix	Saline and Gauze
Number of Device Failures	24	34

SecondaryNumber 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.

Time frame:: Week 1 to Week 24
Reported as:: Number · Devices

Number of Device Removals
Devices	Biologic - Unite Biomatrix	Saline and Gauze
Number of Device Removals	24	34

SecondaryEase of Dressing Use

Ease of usage on a 5-point scale where 1=greatest ease of use and 5=greatest difficult

Time frame:: Week 1 to Week 12
Reported as:: Mean · Score on a Scale

Ease of Dressing Use
Score on a Scale	Biologic - Unite Biomatrix	Saline and Gauze
Ease of Preparation	1.4 ± 0.6	—
Handling	1.2 ± 0.6	—
Comfortability	1.5 ± 0.7	—
Securability	1.4 ± 0.6	—

Adverse events

Collected over Day -12 through Day 180. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Biologic - Unite Biomatrix	1/42 (2.4%)	9/42 (21.4%)	6/42 (14.3%)
Saline and Gauze	2/48 (4.2%)	8/48 (16.7%)	7/48 (14.6%)

Most frequent serious events

Showing 10 of 13

Most frequent serious events
Event	Biologic - Unite Biomatrix	Saline and Gauze
InfectionInfections and infestations	4/42	2/48
OsteomyelitisMusculoskeletal and connective tissue disorders	3/42	2/48
DeathInvestigations	1/42	1/48
Abdominal PainGeneral disorders	1/42	0/48
VomitingGeneral disorders	1/42	0/48
HyperglycemiaBlood and lymphatic system disorders	1/42	0/48
HypotensionVascular disorders	1/42	0/48
CellulitisSkin and subcutaneous tissue disorders	0/42	1/48
Congestive Heart FailureCardiac disorders	0/42	1/48
HypertensionVascular disorders	0/42	1/48

Most frequent other events

Most frequent other events
Event	Biologic - Unite Biomatrix	Saline and Gauze
InfectionInfections and infestations	2/42	3/48
BlisterInjury, poisoning and procedural complications	2/42	0/48
UlcerEndocrine disorders	0/42	2/48
OsteomyelitisMusculoskeletal and connective tissue disorders	1/42	1/48
Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/42	0/48
InfluenzaRespiratory, thoracic and mediastinal disorders	1/42	0/48
Back InjuryInjury, poisoning and procedural complications	1/42	0/48
CellulitisSkin and subcutaneous tissue disorders	0/42	1/48

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Biologic - Unite Biomatrix	Saline and Gauze	Total
Mean	58.1 ± 10.7	54.9 ± 10.2	56.39 ± 10.4

Sex: Female, Male
Sex: Female, Male(Participants)	Biologic - Unite Biomatrix	Saline and Gauze	Total
Female	10	14	24
Male	32	34	66

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Biologic - Unite Biomatrix	Saline and Gauze	Total
Caucasian	24	24	48
Black	11	19	30
Hispanic	6	4	10
Pacific Islander	1	1	2

Study locations

11 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00958711
Lead sponsor: Baxter Healthcare Corporation
Collaborators: Synovis Surgical Innovations
Responsible party: Sponsor
First posted: Aug 13, 2009
Start date: Jan 2009
Primary completion: May 2012
Completion: May 2012
Results posted: Dec 18, 2019
Last update: Dec 18, 2019

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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