Trial Outcomes & Findings for Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU) (NCT NCT06319287)

NCT ID: NCT06319287

Last Updated: 2026-07-20

Results Overview

Complete wound closure (wound healing) by 12 weeks (efficacy; landmark analysis)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

12 weeks

Results posted on

2026-07-20

Participant Flow

Subjects recruited from clinics. Study Initiation Date (First Subject First Visit \[FSFV\]): 27 March 2024 Study Completion Date (Last Subject Last Visit \[LSLV\]): 23 April 2025

Participant milestones

Participant milestones
Measure	Arm A (PEP-TISSEEL +SOC) PEP-TISSEEL+SOC topically applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up	Arm B (SOC) SOC applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up
Overall Study STARTED	28	31
Overall Study COMPLETED	18	20
Overall Study NOT COMPLETED	10	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

\# of participants with LE amputations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (PEP-TISSEEL +SOC) n=28 Participants PEP-TISSEEL+SOC topically applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up	Arm B (SOC) n=31 Participants SOC applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up	Total n=59 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=20 Participants	24 Participants n=20 Participants	48 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=20 Participants	25 Participants n=20 Participants	40 Participants n=40 Participants
Age, Categorical >=65 years	13 Participants n=20 Participants	6 Participants n=20 Participants	19 Participants n=40 Participants
Sex: Female, Male Female	4 Participants n=20 Participants	7 Participants n=20 Participants	11 Participants n=40 Participants
Sex: Female, Male Male	24 Participants n=20 Participants	24 Participants n=20 Participants	48 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	1 Participants n=20 Participants	2 Participants n=20 Participants	3 Participants n=40 Participants
Race (NIH/OMB) White	27 Participants n=20 Participants	28 Participants n=20 Participants	55 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=20 Participants	7 Participants n=20 Participants	11 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Weight	199.2 Pounds STANDARD_DEVIATION 53.34 • n=20 Participants	206.5 Pounds STANDARD_DEVIATION 42.26 • n=20 Participants	203.0 Pounds STANDARD_DEVIATION 47.56 • n=40 Participants
Height	68.0 Inches STANDARD_DEVIATION 3.57 • n=20 Participants	68.7 Inches STANDARD_DEVIATION 5.10 • n=20 Participants	68.4 Inches STANDARD_DEVIATION 4.42 • n=40 Participants
BMI	30.2 kg/m^2 STANDARD_DEVIATION 7.56 • n=20 Participants	30.7 kg/m^2 STANDARD_DEVIATION 5.22 • n=20 Participants	30.5 kg/m^2 STANDARD_DEVIATION 6.38 • n=40 Participants
Smoking Status Current	3 Participants n=20 Participants	3 Participants n=20 Participants	6 Participants n=40 Participants
Smoking Status Former	5 Participants n=20 Participants	4 Participants n=20 Participants	9 Participants n=40 Participants
Smoking Status Never	20 Participants n=20 Participants	24 Participants n=20 Participants	44 Participants n=40 Participants
Cardiac Disorder Yes	2 Participants n=20 Participants	4 Participants n=20 Participants	6 Participants n=40 Participants
Cardiac Disorder No	26 Participants n=20 Participants	27 Participants n=20 Participants	53 Participants n=40 Participants
Chronic Kidney Disease Yes	2 Participants n=20 Participants	2 Participants n=20 Participants	4 Participants n=40 Participants
Chronic Kidney Disease No	26 Participants n=20 Participants	29 Participants n=20 Participants	55 Participants n=40 Participants
Hypertension Yes	22 Participants n=20 Participants	25 Participants n=20 Participants	47 Participants n=40 Participants
Hypertension No	6 Participants n=20 Participants	6 Participants n=20 Participants	12 Participants n=40 Participants
Hyperlipidemia Yes	16 Participants n=20 Participants	18 Participants n=20 Participants	34 Participants n=40 Participants
Hyperlipidemia No	12 Participants n=20 Participants	13 Participants n=20 Participants	25 Participants n=40 Participants
Peripheral Arterial Disease Yes	4 Participants n=20 Participants	1 Participants n=20 Participants	5 Participants n=40 Participants
Peripheral Arterial Disease No	24 Participants n=20 Participants	30 Participants n=20 Participants	54 Participants n=40 Participants
Peripheral Neuropathy Yes	21 Participants n=20 Participants	25 Participants n=20 Participants	46 Participants n=40 Participants
Peripheral Neuropathy No	7 Participants n=20 Participants	6 Participants n=20 Participants	13 Participants n=40 Participants
Psychiatric Disorder Yes	9 Participants n=20 Participants	5 Participants n=20 Participants	14 Participants n=40 Participants
Psychiatric Disorder No	19 Participants n=20 Participants	26 Participants n=20 Participants	45 Participants n=40 Participants
Ulcer Area at Baseline	2.7 cm^2 STANDARD_DEVIATION 1.79 • n=20 Participants	2.7 cm^2 STANDARD_DEVIATION 2.30 • n=20 Participants	2.7 cm^2 STANDARD_DEVIATION 2.06 • n=40 Participants
Ulcer Age	8.0 Weeks STANDARD_DEVIATION 1.37 • n=20 Participants	7.5 Weeks STANDARD_DEVIATION 1.48 • n=20 Participants	7.8 Weeks STANDARD_DEVIATION 1.44 • n=40 Participants
Location of Ulcer Dorsal	7 Participants n=20 Participants	10 Participants n=20 Participants	17 Participants n=40 Participants
Location of Ulcer Plantar	21 Participants n=20 Participants	21 Participants n=20 Participants	42 Participants n=40 Participants
Location of DFU on Foot Toe	4 Participants n=20 Participants	3 Participants n=20 Participants	7 Participants n=40 Participants
Location of DFU on Foot Forefoot	11 Participants n=20 Participants	15 Participants n=20 Participants	26 Participants n=40 Participants
Location of DFU on Foot Midfoot	9 Participants n=20 Participants	11 Participants n=20 Participants	20 Participants n=40 Participants
Location of DFU on Foot Hindfoot	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants
Location of DFU on Foot Heel	3 Participants n=20 Participants	0 Participants n=20 Participants	3 Participants n=40 Participants
Location of DFU on Foot Ankle	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
History of DFU Recurrence Yes	16 Participants n=20 Participants	15 Participants n=20 Participants	31 Participants n=40 Participants
History of DFU Recurrence No	12 Participants n=20 Participants	16 Participants n=20 Participants	28 Participants n=40 Participants
Concurrent DFUs Yes	2 Participants n=20 Participants	1 Participants n=20 Participants	3 Participants n=40 Participants
Concurrent DFUs No	26 Participants n=20 Participants	30 Participants n=20 Participants	56 Participants n=40 Participants
DFU Lifetime Count	2.8 DFUs STANDARD_DEVIATION 3.41 • n=20 Participants	2.0 DFUs STANDARD_DEVIATION 1.45 • n=20 Participants	2.4 DFUs STANDARD_DEVIATION 2.59 • n=40 Participants
Prior LE Amputation No :	11 Participants n=20 Participants • \# of participants with LE amputations	17 Participants n=20 Participants • \# of participants with LE amputations	28 Participants n=40 Participants • \# of participants with LE amputations
Prior LE Amputation Yes :	17 Participants n=20 Participants • \# of participants with LE amputations	14 Participants n=20 Participants • \# of participants with LE amputations	31 Participants n=40 Participants • \# of participants with LE amputations
Offloading Type Total Contact Cast (TCC)	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Offloading Type Controlled Ankle Motion (CAM) Boot	6 Participants n=20 Participants	10 Participants n=20 Participants	16 Participants n=40 Participants
Offloading Type Diabetic Shoe	10 Participants n=20 Participants	9 Participants n=20 Participants	19 Participants n=40 Participants
Offloading Type Local Offloading	2 Participants n=20 Participants	1 Participants n=20 Participants	3 Participants n=40 Participants
Offloading Type Other	2 Participants n=20 Participants	0 Participants n=20 Participants	2 Participants n=40 Participants
Offloading Type No	8 Participants n=20 Participants	11 Participants n=20 Participants	19 Participants n=40 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Comparison of Complete Ulcer Healing by 12 Weeks - ITT Population

Complete wound closure (wound healing) by 12 weeks (efficacy; landmark analysis)

Outcome measures

Outcome measures
Measure	Arm A (PEP-TISSEEL +SOC) n=28 Participants PEP-TISSEEL+SOC topically applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up	Arm B (SOC) n=31 Participants SOC applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up
Complete Wound Closure	13 Participants	7 Participants

PRIMARY outcome

Timeframe: 12 week treatment + 3 month (12 weeks) non-dosing Safety Follow-Up

Population: Safety Population - ITT

Count dose limiting toxicity events.

Outcome measures

Outcome measures
Measure	Arm A (PEP-TISSEEL +SOC) n=28 Participants PEP-TISSEEL+SOC topically applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up	Arm B (SOC) n=31 Participants SOC applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up
Dose Limiting Toxicities	0 DLT Event Count	0 DLT Event Count

SECONDARY outcome

Timeframe: 12 weeks

Population: Comparison of Mean Percent Reduction of Ulcer Area from Baseline by Week 12 Visit - mITT Population Set 1

Percentage area reduction (PAR) at 12 weeks.

Outcome measures

Outcome measures
Measure	Arm A (PEP-TISSEEL +SOC) n=23 Participants PEP-TISSEEL+SOC topically applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up	Arm B (SOC) n=24 Participants SOC applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up
Percent Area Reduction of Wound at 12 Weeks	78.9 Percent reduction Standard Deviation 33.23	66.2 Percent reduction Standard Deviation 47.00

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: mITT Population Set 2: all randomized subjects, regardless of actual treatment, and whether they were later found to be ineligible for the study because they failed to meet all inclusion and exclusion criteria, provided that subjects experienced a NPRS pain score of \>0 at any time during the study.

VAS pain (mean difference between baseline and 12 weeks) from 0 (No Pain) to 10 (Worst Possible Pain)

Outcome measures

Outcome measures
Measure	Arm A (PEP-TISSEEL +SOC) n=23 Participants PEP-TISSEEL+SOC topically applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up	Arm B (SOC) n=22 Participants SOC applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up
Visual Analogue Scale (VAS) for Pain Over 12 Weeks	1.5 Score on a scale Standard Deviation 2.15	0.6 Score on a scale Standard Deviation 1.65

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Semmes Weinstein 10-Point Monofilament Test is a non-invasive topical evaluation of neuropathy with a monofilament wire (10-gram 5.07 Level) and scores the ability to detect light touch at specific sites on the foot, with 10/10 indicating normal sensation and fewer than 8/10 indicating Loss of Protective Sensation (LOPS) and high-risk diabetic neuropathy. Foot sites tested are 1) plantar surface of the great toe, 2) plantar surface of the 3rd toe, 3) plantar surface of the 5th toe, 4) 1st metatarsal head, 5) 3rd metatarsal head, 6) 5th metatarsal head, 7) arch of the foot, 8) heal, 9) dorsal great toe, and 10) 2nd toe interspace. Key Scoring \& Interpretation: Normal: Feeling all 10 sites (10/10) or, in some protocols, 8 or more sites. Abnormal (LOPS): Failling to feel the monofilament at 3 or more sites (7 or fewer detected) is commonly defined as abnormal sensation (neuropathy) Each site is added for the score which would be a maximum of 10 or a minimum of 0 (no response).

Outcome measures

Outcome measures
Measure	Arm A (PEP-TISSEEL +SOC) n=14 Participants PEP-TISSEEL+SOC topically applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up	Arm B (SOC) n=16 Participants SOC applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up
Semmes-Weinstein Score (Mean Difference Between Baseline and 12 Weeks)	1.9 Score Standard Deviation 2.90	5.7 Score Standard Deviation 4.31

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Wound-Q (domains: wound characteristics and health-related quality of life; mean difference between baseline and 12 weeks) WOUND-Q questionnaire is a patient-reported outcome used with all types of chronic wounds in any anatomical location to assess quality of life. Wound Characteristics and Health-Related Quality of Life domains include the following 10 scales: Wound Concerns, Drainage, Smell, Financial Impact, Physical Function, Lower Limb Symptoms, Life Impact, Psychological, Sleep, and Social. Each scale is scored separately, and each scale's summed raw score is transformed to a 0-100 (minimum score: 0 and maximum score: 100) range with higher scores indicating better outcomes. There is no total combined score across scales.

Outcome measures

Outcome measures
Measure	Arm A (PEP-TISSEEL +SOC) n=14 Participants PEP-TISSEEL+SOC topically applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up	Arm B (SOC) n=16 Participants SOC applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up
Wound-Q Scale Wound Concerns	62.4 Score on a scale Standard Deviation 11.04	70.6 Score on a scale Standard Deviation 19.85
Wound-Q Scale Drainage	74.1 Score on a scale Standard Deviation 22.57	81.2 Score on a scale Standard Deviation 25.07
Wound-Q Scale Smell	81.3 Score on a scale Standard Deviation 24.73	86.0 Score on a scale Standard Deviation 27.56
Wound-Q Scale Financial Burden	55.6 Score on a scale Standard Deviation 21.63	64.7 Score on a scale Standard Deviation 24.60
Wound-Q Scale Physical Function	47.9 Score on a scale Standard Deviation 17.93	62.1 Score on a scale Standard Deviation 23.71
Wound-Q Scale Lower Limb	59.6 Score on a scale Standard Deviation 16.07	72.4 Score on a scale Standard Deviation 17.04
Wound-Q Scale Life Impact - Quality of Life	54.7 Score on a scale Standard Deviation 28.96	66.2 Score on a scale Standard Deviation 27.62
Wound-Q Scale Psychological - Feeling	68.4 Score on a scale Standard Deviation 29.42	73.4 Score on a scale Standard Deviation 23.12
Wound-Q Scale Sleep	67.4 Score on a scale Standard Deviation 22.16	83.2 Score on a scale Standard Deviation 18.82
Wound-Q Scale Social	59.4 Score on a scale Standard Deviation 35.79	74.3 Score on a scale Standard Deviation 26.65

Adverse Events

Arm A (PEP-TISSEEL +SOC)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Arm B (SOC)

Serious events: 6 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Shariq Khan, Vice President, Global Clinical Development & Operations

Rion, Inc

Phone: 847-702-4063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves right to delay proposed presentation or publication; however, approval of presentations and publications will not be unreasonably withheld unless withholding of presentation or publication is required.
Publication restrictions are in place

Restriction type: OTHER

Measure	Arm A (PEP-TISSEEL +SOC) n=28 participants at risk PEP-TISSEEL+SOC topically applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up	Arm B (SOC) n=31 participants at risk SOC applied weekly for 12 weeks + 3 month (12 week) non-dosing Safety Follow-Up
Infections and infestations Severe sepsis	0.00% 0/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	3.2% 1/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.
Infections and infestations Acute Chronic obstructive pulmonary disease exacerbation with pneumonia	0.00% 0/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	3.2% 1/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease exacerbation	0.00% 0/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	3.2% 1/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.
Infections and infestations Perineal and Scrotal abscess	0.00% 0/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	3.2% 1/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.
Musculoskeletal and connective tissue disorders Abscess of Tendon Sheath, Left Foot	0.00% 0/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	3.2% 1/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.
Cardiac disorders Chronic diastolic Congestive Heart Failure	3.6% 1/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	0.00% 0/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.
Renal and urinary disorders Stage 4 Chronic Kidney Disease	3.6% 1/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	0.00% 0/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure with Hypoxia	3.6% 1/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	0.00% 0/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.
Blood and lymphatic system disorders Acute on Chronic Anemia	3.6% 1/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	0.00% 0/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.
Infections and infestations CELLULITIS LEFT PLANTAR MIDFOOT ULCER (INDEX ULCER)	3.6% 1/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	0.00% 0/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.
Infections and infestations Sepsis	3.6% 1/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	0.00% 0/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.
Infections and infestations Abscess to left lateral foot	3.6% 1/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	0.00% 0/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.
Nervous system disorders Syncope	0.00% 0/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	3.2% 1/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.
Infections and infestations Right foot abscess, diabetic foot ulcer infected	0.00% 0/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	3.2% 1/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.
Infections and infestations Flu	0.00% 0/28 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.	3.2% 1/31 • AE collection started at Baseline / Randomization through the 3-month Safety follow-up period, up to 6 months total All treatment emergent AE and SAEs occurring from Randomization until after the Safety follow-up period will be reported.