Trial Outcomes & Findings for PriMatrix for the Management of Diabetic Foot Ulcers (NCT NCT03010319)

Last Updated: 2022-04-29

Results Overview

Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without detectable exudate, confirmed on 2 consecutive study visits 1 week apart.

Recruitment status

COMPLETED

Study phase

Target enrollment

226 participants

Primary outcome timeframe

12-week Treatment Phase

Results posted on

2022-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	PriMatrix Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device. PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area	Standard of Care Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device. Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area
Overall Study STARTED	110	116
Overall Study COMPLETED	84	87
Overall Study NOT COMPLETED	26	29

Reasons for withdrawal

Reasons for withdrawal
Measure	PriMatrix Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device. PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area	Standard of Care Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device. Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area
Overall Study Adverse Event	15	9
Overall Study Withdrawal by Subject	1	6
Overall Study Physician Decision	2	4
Overall Study Sponsor requested withdrawal	2	2
Overall Study Death	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Other Reason	5	7

Baseline Characteristics

PriMatrix for the Management of Diabetic Foot Ulcers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PriMatrix n=103 Participants Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device. PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area	Standard of Care n=104 Participants Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device. Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area	Total n=207 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	103 participants n=5 Participants	104 participants n=7 Participants	207 participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	26 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) White	81 Participants n=5 Participants	74 Participants n=7 Participants	155 Participants n=5 Participants
Age, Continuous	58.5 Years STANDARD_DEVIATION 11.92 • n=5 Participants	57.6 Years STANDARD_DEVIATION 11.49 • n=7 Participants	58.0 Years STANDARD_DEVIATION 11.69 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	80 Participants n=7 Participants	163 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	43 Participants n=5 Participants	31 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=5 Participants	73 Participants n=7 Participants	133 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12-week Treatment Phase

Population: Primary Efficacy Population

Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without detectable exudate, confirmed on 2 consecutive study visits 1 week apart.

Outcome measures

Outcome measures
Measure	PriMatrix n=103 Participants Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device. PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area	Standard of Care n=104 Participants Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device. Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area
Percentage of Subjects With Complete Wound Closure, as Assessed by the Investigator, at or Before Week 12 of the Treatment Phase	47 Participants	29 Participants

SECONDARY outcome

Timeframe: 12-week treatment phase

Population: Primary Efficacy Population

Outcome measures

Outcome measures
Measure	PriMatrix n=103 Participants Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device. PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area	Standard of Care n=104 Participants Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device. Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area
Percentage of Subjects With Complete Wound Closure, as Assessed by Computerized Planimetry, at or Before Week 12 of the Treatment Phase	36 Participants	20 Participants

SECONDARY outcome

Timeframe: 12-week Treatment Phase

Population: Primary Efficacy Population with Complete Wound Closure

Outcome measures

Outcome measures
Measure	PriMatrix n=47 Participants Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device. PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area	Standard of Care n=29 Participants Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device. Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area
Time to Complete Wound Closure, as Assessed by the Investigator	53.6 days Standard Deviation 21.39	56.2 days Standard Deviation 18.24

SECONDARY outcome

Timeframe: 12-week Treatment Phase

Population: Primary Efficacy Population with Complete Wound Closure

Outcome measures

Outcome measures
Measure	PriMatrix n=36 Participants Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device. PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area	Standard of Care n=20 Participants Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device. Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area
Time to Complete Wound Closure, as Assessed by Computerized Planimetry.	51.8 days Standard Deviation 20.63	56.8 days Standard Deviation 16.25

SECONDARY outcome

Timeframe: Weeks 1-12 during Treatment Phase

Population: Primary Efficacy Population

Rate of Wound closure was recorded as the percentage of the wound that was closed, per week. NOTE1: Rate (% closed/week) = 7 \* \[(Baseline wound size) - (Post-baseline wound size)\]/\[(Baseline wound size) \* (days in trial)\] NOTE2: Missing data is imputed using LOCF method for this analysis

Outcome measures

Outcome measures
Measure	PriMatrix n=103 Participants Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device. PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area	Standard of Care n=104 Participants Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device. Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area
Rate of Wound Closure, as Assessed by Computerized Planimetry. Week 1	1.727 Percentage of Wound Closed/Week Standard Deviation 7.142	0.996 Percentage of Wound Closed/Week Standard Deviation 8.222
Rate of Wound Closure, as Assessed by Computerized Planimetry. Week 2	1.722 Percentage of Wound Closed/Week Standard Deviation 9.446	1.999 Percentage of Wound Closed/Week Standard Deviation 9.366
Rate of Wound Closure, as Assessed by Computerized Planimetry. Week 3	2.587 Percentage of Wound Closed/Week Standard Deviation 10.082	2.524 Percentage of Wound Closed/Week Standard Deviation 9.304
Rate of Wound Closure, as Assessed by Computerized Planimetry. Week 4	3.443 Percentage of Wound Closed/Week Standard Deviation 9.376	2.990 Percentage of Wound Closed/Week Standard Deviation 9.653
Rate of Wound Closure, as Assessed by Computerized Planimetry. Week 5	3.603 Percentage of Wound Closed/Week Standard Deviation 9.371	3.476 Percentage of Wound Closed/Week Standard Deviation 9.549
Rate of Wound Closure, as Assessed by Computerized Planimetry. Week 6	3.764 Percentage of Wound Closed/Week Standard Deviation 9.441	3.279 Percentage of Wound Closed/Week Standard Deviation 9.951
Rate of Wound Closure, as Assessed by Computerized Planimetry. Week 7	4.054 Percentage of Wound Closed/Week Standard Deviation 9.402	3.308 Percentage of Wound Closed/Week Standard Deviation 10.072
Rate of Wound Closure, as Assessed by Computerized Planimetry. Week 8	4.017 Percentage of Wound Closed/Week Standard Deviation 9.759	3.632 Percentage of Wound Closed/Week Standard Deviation 10.115
Rate of Wound Closure, as Assessed by Computerized Planimetry. Week 9	4.213 Percentage of Wound Closed/Week Standard Deviation 9.554	3.820 Percentage of Wound Closed/Week Standard Deviation 10.184
Rate of Wound Closure, as Assessed by Computerized Planimetry. Week 10	3.970 Percentage of Wound Closed/Week Standard Deviation 10.230	3.896 Percentage of Wound Closed/Week Standard Deviation 10.184
Rate of Wound Closure, as Assessed by Computerized Planimetry. Week 11	4.558 Percentage of Wound Closed/Week Standard Deviation 9.480	3.837 Percentage of Wound Closed/Week Standard Deviation 10.186
Rate of Wound Closure, as Assessed by Computerized Planimetry. Week 12	4.637 Percentage of Wound Closed/Week Standard Deviation 9.513	3.928 Percentage of Wound Closed/Week Standard Deviation 10.263

Adverse Events

PriMatrix

Serious events: 19 serious events

Other events: 16 other events

Deaths: 1 deaths

Standard of Care

Serious events: 15 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	PriMatrix n=110 participants at risk Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device. PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area	Standard of Care n=116 participants at risk Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device. Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area
Infections and infestations Diabetic Foot Infection	7.3% 8/110 • Number of events 8 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	9.5% 11/116 • Number of events 11 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Infections and infestations Diabetic Foot	7.3% 8/110 • Number of events 8 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	10.3% 12/116 • Number of events 12 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.

Additional Information

Andrew Tummon Director, Global Clinical Affairs

Integra LifeSciences

Phone: 609-936-5490

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators are barred from publishing or disclosing results until a multicenter publication is published or until a period of 24 months after study completion passes, whichever comes first.
Publication restrictions are in place

Restriction type: OTHER

Measure	PriMatrix n=110 participants at risk Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device. PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area	Standard of Care n=116 participants at risk Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device. Secondary Dressings: Dressings to ensure moist wound environment Offloading device: Offloading device to decrease pressure to wound area
Cardiac disorders Acute myocardial infarction	0.91% 1/110 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.00% 0/116 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Cardiac disorders Cardio-respiratory arrest	0.91% 1/110 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.00% 0/116 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
General disorders Catheter site thrombosis	0.91% 1/110 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.00% 0/116 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Gastrointestinal disorders Chest Pain	0.91% 1/110 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.00% 0/116 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Infections and infestations Cellulitis	1.8% 2/110 • Number of events 2 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	1.7% 2/116 • Number of events 2 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Infections and infestations Clostridium difficile infection	0.00% 0/110 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.86% 1/116 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Infections and infestations Diabetic foot infection	2.7% 3/110 • Number of events 3 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	6.0% 7/116 • Number of events 7 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Infections and infestations Gangrene	0.00% 0/110 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.86% 1/116 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Infections and infestations Osteomyelitis	7.3% 8/110 • Number of events 8 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	2.6% 3/116 • Number of events 3 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Infections and infestations Septic Shock	0.00% 0/110 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.86% 1/116 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Infections and infestations Staphylococcal infection	0.91% 1/110 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.00% 0/116 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Infections and infestations Urinary Track Infection	0.91% 1/110 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.00% 0/116 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/110 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.86% 1/116 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.91% 1/110 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.00% 0/116 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Metabolism and nutrition disorders Hyperglycemia	0.91% 1/110 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.00% 0/116 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Metabolism and nutrition disorders Shock hypoglycemic	0.91% 1/110 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.00% 0/116 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/110 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.86% 1/116 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Skin and subcutaneous tissue disorders Skin necrosis	0.91% 1/110 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.00% 0/116 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Surgical and medical procedures Coronary artery bypass	0.91% 1/110 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.00% 0/116 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Surgical and medical procedures Foot amputation	0.00% 0/110 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.86% 1/116 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Surgical and medical procedures Metatarsal excision	0.91% 1/110 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.00% 0/116 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Vascular disorders Angiopathy	0.00% 0/110 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.86% 1/116 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Vascular disorders Peripheral artery occlusion	0.00% 0/110 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.86% 1/116 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.
Vascular disorders Peripheral ischemia	0.91% 1/110 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.	0.86% 1/116 • Number of events 1 • Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks. Adverse Event Reporting population is the Safety Population.