Trial Outcomes & Findings for Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers (NCT NCT02563522)

NCT ID: NCT02563522

Last Updated: 2025-10-09

Results Overview

Determine the proportion of subjects with a target Wound Closure from baseline to month 4 visit

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

44 participants

Primary outcome timeframe

Days 0 to Month 4

Results posted on

2025-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Active Engensis (VM202) + standard of care Engensis (VM202): gene therapy	Control Placebo (VM202 Vehicle) + standard of care Placebo: Standard of care plus placebo
Overall Study STARTED	27	17
Overall Study COMPLETED	23	12
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Engensis (VM202) + standard of care Engensis (VM202): gene therapy	Control Placebo (VM202 Vehicle) + standard of care Placebo: Standard of care plus placebo
Overall Study Adverse Event	2	3
Overall Study Lost to Follow-up	1	0
Overall Study withdrew consent,, noncompliance, and unable to attend future visits	1	2

Baseline Characteristics

Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=27 Participants Engensis (VM202) + standard of care Engensis (VM202): gene therapy	Control n=17 Participants Placebo (VM202 Vehicle) + standard of care Placebo: Standard of care plus placebo	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants	8 Participants n=4 Participants	28 Participants n=27 Participants
Age, Categorical >=65 years	7 Participants n=93 Participants	9 Participants n=4 Participants	16 Participants n=27 Participants
Age, Continuous	57.5 years STANDARD_DEVIATION 11.05 • n=93 Participants	61.2 years STANDARD_DEVIATION 10.88 • n=4 Participants	58.9 years STANDARD_DEVIATION 11.00 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	5 Participants n=4 Participants	12 Participants n=27 Participants
Sex: Female, Male Male	20 Participants n=93 Participants	12 Participants n=4 Participants	32 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) White	21 Participants n=93 Participants	15 Participants n=4 Participants	36 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	27 participants n=93 Participants	17 participants n=4 Participants	44 participants n=27 Participants

PRIMARY outcome

Timeframe: Days 0 to Month 4

Determine the proportion of subjects with a target Wound Closure from baseline to month 4 visit

Outcome measures

Outcome measures
Measure	Active n=27 Participants Engensis (VM202) + standard of care Engensis (VM202): gene therapy	Control n=17 Participants Placebo (VM202 Vehicle) + standard of care Placebo: Standard of care plus placebo
Proportion of Subjects With a Target Wound Closure by the 4-month Follow-up Visit	13 Participants	5 Participants

Adverse Events

Active

Serious events: 11 serious events

Other events: 16 other events

Deaths: 0 deaths

Control

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Jinsub Lee, PhD.

Helixmith Co., Ltd.

Phone: +82-10-8256-0439

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Active n=27 participants at risk Engensis (VM202) + standard of care Engensis (VM202): gene therapy	Control n=17 participants at risk Placebo (VM202 Vehicle) + standard of care Placebo: Standard of care plus placebo
Infections and infestations Infected skin ulcer	7.4% 2/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	11.8% 2/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Infections and infestations Osteomyelitis	14.8% 4/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	0.00% 0/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Infections and infestations Urinary tract infection	3.7% 1/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	11.8% 2/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Infections and infestations Cellulitis	7.4% 2/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	0.00% 0/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Infections and infestations Localised infection	7.4% 2/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	0.00% 0/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Infections and infestations Sepsis	7.4% 2/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	0.00% 0/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Vascular disorders Peripheral vascular disorder	0.00% 0/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	11.8% 2/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Vascular disorders Hypotension	0.00% 0/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	5.9% 1/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	5.9% 1/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Infections and infestations Septic shock	0.00% 0/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	5.9% 1/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Injury, poisoning and procedural complications Limb injury	0.00% 0/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	5.9% 1/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Musculoskeletal and connective tissue disorders Arthralgia	3.7% 1/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	0.00% 0/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Cardiac disorders Acute myocardial infarction	3.7% 1/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	0.00% 0/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Cardiac disorders Cardiac failure congestive	3.7% 1/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	0.00% 0/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Gastrointestinal disorders Gastrointestinal haemorrhage	3.7% 1/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	0.00% 0/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Blood and lymphatic system disorders Anaemia	3.7% 1/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	0.00% 0/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Infections and infestations Abscess limb	3.7% 1/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	0.00% 0/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Nervous system disorders Hypoglycaemic encrephalopathy	3.7% 1/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	0.00% 0/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Nervous system disorders Cerebrovascular accident	3.7% 1/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	0.00% 0/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)
Pregnancy, puerperium and perinatal conditions Abortion missed	3.7% 1/27 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)	0.00% 0/17 • Day 0 to 7 months Treatment-emergent serious adverse events (TESAEs)