Trial Outcomes & Findings for The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer (NCT NCT00958711)
NCT ID: NCT00958711
Last Updated: 2019-12-18
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Day 20, Day 40, Day 60, Day 80
Results posted on
2019-12-18
Participant Flow
Participant milestones
| Measure |
Biologic - Unite Biomatrix
Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
|
Saline and Gauze
Saline and Gauze: gauze moistened with sterile saline
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
48
|
|
Overall Study
COMPLETED
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
13
|
21
|
Reasons for withdrawal
| Measure |
Biologic - Unite Biomatrix
Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
|
Saline and Gauze
Saline and Gauze: gauze moistened with sterile saline
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Physician Decision
|
5
|
7
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Other
|
2
|
5
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Adverse Event
|
1
|
2
|
Baseline Characteristics
The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer
Baseline characteristics by cohort
| Measure |
Biologic - Unite Biomatrix
n=42 Participants
Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
|
Saline and Gauze
n=48 Participants
Saline and Gauze: gauze moistened with sterile saline
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
54.9 Years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
56.39 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 20, Day 40, Day 60, Day 80Population: Intent-to-Treat (ITT): all randomized participants who provided consent..
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.
Outcome measures
| Measure |
Biologic - Unite Biomatrix
n=42 Participants
Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
|
Saline and Gauze
n=48 Participants
Saline and Gauze: gauze moistened with sterile saline
|
|---|---|---|
|
Percentage of Participants Not Healed by Number of Days After Procedure
Day 20
|
0.97 Percentage of Participants
|
1.0 Percentage of Participants
|
|
Percentage of Participants Not Healed by Number of Days After Procedure
Day 40
|
0.91 Percentage of Participants
|
0.95 Percentage of Participants
|
|
Percentage of Participants Not Healed by Number of Days After Procedure
Day 60
|
0.74 Percentage of Participants
|
0.74 Percentage of Participants
|
|
Percentage of Participants Not Healed by Number of Days After Procedure
Day 80
|
0.61 Percentage of Participants
|
0.65 Percentage of Participants
|
PRIMARY outcome
Timeframe: Week 12Population: ITT
Outcome measures
| Measure |
Biologic - Unite Biomatrix
n=42 Participants
Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
|
Saline and Gauze
n=48 Participants
Saline and Gauze: gauze moistened with sterile saline
|
|---|---|---|
|
Percentage of Participants With Wounds Healed at 12 Weeks
Healed
|
42.9 Percentage of participants
|
29.2 Percentage of participants
|
|
Percentage of Participants With Wounds Healed at 12 Weeks
Not Healed
|
57.1 Percentage of participants
|
70.8 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0, 72 hours post-procedure, Week 1, Week 2, Week 4Population: Source document notes "no data provided." Limited information available since product no longer licensed with Baxter.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 0, Week 1 - Week 12Population: Source document notes "no data provided." Limited information available since product no longer licensed with Baxter.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0, Week 4, Week 8, Week 12Population: ITT
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.
Outcome measures
| Measure |
Biologic - Unite Biomatrix
n=42 Participants
Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
|
Saline and Gauze
n=48 Participants
Saline and Gauze: gauze moistened with sterile saline
|
|---|---|---|
|
Percentage Mean of Original Wound Size From Baseline by Week
Week 12 Width
|
0.323 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
0.465 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
|
Percentage Mean of Original Wound Size From Baseline by Week
Week 8 Length
|
0.705 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
0.695 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
|
Percentage Mean of Original Wound Size From Baseline by Week
Week 8 Width
|
0.650 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
0.671 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
|
Percentage Mean of Original Wound Size From Baseline by Week
Week 4 Length
|
0.879 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
0.754 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
|
Percentage Mean of Original Wound Size From Baseline by Week
Week 4 Width
|
0.809 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
0.750 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
|
Percentage Mean of Original Wound Size From Baseline by Week
Week 4 Depth
|
0.820 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
1.082 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
|
Percentage Mean of Original Wound Size From Baseline by Week
Week 4 Area
|
0.807 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
0.732 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
|
Percentage Mean of Original Wound Size From Baseline by Week
Week 8 Depth
|
1.612 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
1.365 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
|
Percentage Mean of Original Wound Size From Baseline by Week
Week 8 Area
|
0.546 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
0.592 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
|
Percentage Mean of Original Wound Size From Baseline by Week
Week 12 Length
|
0.381 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
0.567 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
|
Percentage Mean of Original Wound Size From Baseline by Week
Week 12 Depth
|
0.304 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
1.347 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
|
Percentage Mean of Original Wound Size From Baseline by Week
Week 12 Area
|
0.341 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
0.433 Percentage mean of wound size
Standard Deviation NA
Study sponsored by other company, and only abbreviated results available without this data point.
|
SECONDARY outcome
Timeframe: Week 1 to Week 24Population: ITT
Outcome measures
| Measure |
Biologic - Unite Biomatrix
n=42 Participants
Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
|
Saline and Gauze
n=48 Participants
Saline and Gauze: gauze moistened with sterile saline
|
|---|---|---|
|
Number of Participants With Ulcer Recurrence
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 1 to Week 24Population: ITT
Outcome measures
| Measure |
Biologic - Unite Biomatrix
n=42 Participants
Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
|
Saline and Gauze
n=48 Participants
Saline and Gauze: gauze moistened with sterile saline
|
|---|---|---|
|
Number of Device-related Adverse Events (AE)
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: Week 1 to Week 24Population: ITT
Outcome measures
| Measure |
Biologic - Unite Biomatrix
n=42 Participants
Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
|
Saline and Gauze
n=48 Participants
Saline and Gauze: gauze moistened with sterile saline
|
|---|---|---|
|
Number of Procedure-related Adverse Events (AE)
|
2 Events
|
0 Events
|
SECONDARY outcome
Timeframe: Week 1 to Week 24Population: ITT
Includes failure to heal the ulcer by the 12-week visit under the Intent-to-Treat principle.
Outcome measures
| Measure |
Biologic - Unite Biomatrix
n=42 Participants
Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
|
Saline and Gauze
n=48 Participants
Saline and Gauze: gauze moistened with sterile saline
|
|---|---|---|
|
Number of Device Failures
|
24 Devices
|
34 Devices
|
SECONDARY outcome
Timeframe: Week 1 to Week 24Population: ITT
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.
Outcome measures
| Measure |
Biologic - Unite Biomatrix
n=42 Participants
Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
|
Saline and Gauze
n=48 Participants
Saline and Gauze: gauze moistened with sterile saline
|
|---|---|---|
|
Number of Device Removals
|
24 Devices
|
34 Devices
|
SECONDARY outcome
Timeframe: Week 1 to Week 12Population: ITT. Note: Limited information available since product no longer licensed with Baxter. The only stats analysis information available provides data for Unite Biomatrix treatment arm, and will need to assume analysis was not performed for control arm.
Ease of usage on a 5-point scale where 1=greatest ease of use and 5=greatest difficult
Outcome measures
| Measure |
Biologic - Unite Biomatrix
n=42 Participants
Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
|
Saline and Gauze
Saline and Gauze: gauze moistened with sterile saline
|
|---|---|---|
|
Ease of Dressing Use
Ease of Preparation
|
1.4 Score on a Scale
Standard Deviation 0.6
|
—
|
|
Ease of Dressing Use
Handling
|
1.2 Score on a Scale
Standard Deviation 0.6
|
—
|
|
Ease of Dressing Use
Comfortability
|
1.5 Score on a Scale
Standard Deviation 0.7
|
—
|
|
Ease of Dressing Use
Securability
|
1.4 Score on a Scale
Standard Deviation 0.6
|
—
|
Adverse Events
Biologic - Unite Biomatrix
Serious events: 9 serious events
Other events: 6 other events
Deaths: 1 deaths
Saline and Gauze
Serious events: 8 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Biologic - Unite Biomatrix
n=42 participants at risk
Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
|
Saline and Gauze
n=48 participants at risk
Saline and Gauze: gauze moistened with sterile saline
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/42 • Day -12 through Day 180
Source vocabulary unknown.
|
2.1%
1/48 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
7.1%
3/42 • Number of events 3 • Day -12 through Day 180
Source vocabulary unknown.
|
4.2%
2/48 • Number of events 2 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Infections and infestations
Infection
|
9.5%
4/42 • Number of events 4 • Day -12 through Day 180
Source vocabulary unknown.
|
4.2%
2/48 • Number of events 2 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Investigations
Death
|
2.4%
1/42 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
2.1%
1/48 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/42 • Day -12 through Day 180
Source vocabulary unknown.
|
2.1%
1/48 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Vascular disorders
Hypertension
|
0.00%
0/42 • Day -12 through Day 180
Source vocabulary unknown.
|
2.1%
1/48 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Surgical and medical procedures
Foot amputation
|
0.00%
0/42 • Day -12 through Day 180
Source vocabulary unknown.
|
2.1%
1/48 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress
|
0.00%
0/42 • Day -12 through Day 180
Source vocabulary unknown.
|
2.1%
1/48 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/42 • Day -12 through Day 180
Source vocabulary unknown.
|
2.1%
1/48 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
|
General disorders
Abdominal Pain
|
2.4%
1/42 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
0.00%
0/48 • Day -12 through Day 180
Source vocabulary unknown.
|
|
General disorders
Vomiting
|
2.4%
1/42 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
0.00%
0/48 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
2.4%
1/42 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
0.00%
0/48 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Vascular disorders
Hypotension
|
2.4%
1/42 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
0.00%
0/48 • Day -12 through Day 180
Source vocabulary unknown.
|
Other adverse events
| Measure |
Biologic - Unite Biomatrix
n=42 participants at risk
Unite Biomatrix: Collagen based, decellularized equine pericardial dressing for skin surface wounds
|
Saline and Gauze
n=48 participants at risk
Saline and Gauze: gauze moistened with sterile saline
|
|---|---|---|
|
Infections and infestations
Infection
|
4.8%
2/42 • Number of events 3 • Day -12 through Day 180
Source vocabulary unknown.
|
6.2%
3/48 • Number of events 4 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Endocrine disorders
Ulcer
|
0.00%
0/42 • Day -12 through Day 180
Source vocabulary unknown.
|
4.2%
2/48 • Number of events 2 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
2.4%
1/42 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
2.1%
1/48 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/42 • Day -12 through Day 180
Source vocabulary unknown.
|
2.1%
1/48 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Injury, poisoning and procedural complications
Blister
|
4.8%
2/42 • Number of events 2 • Day -12 through Day 180
Source vocabulary unknown.
|
0.00%
0/48 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
2.4%
1/42 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
0.00%
0/48 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
2.4%
1/42 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
0.00%
0/48 • Day -12 through Day 180
Source vocabulary unknown.
|
|
Injury, poisoning and procedural complications
Back Injury
|
2.4%
1/42 • Number of events 1 • Day -12 through Day 180
Source vocabulary unknown.
|
0.00%
0/48 • Day -12 through Day 180
Source vocabulary unknown.
|
Additional Information
Baxter Clinical Trials Disclosure Call Center
Baxter Healthcare
Phone: (224) 948-7359
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60