Trial Outcomes & Findings for Hepatocyte Growth Factor to Improve Functioning in PAD (NCT NCT03363165)
NCT ID: NCT03363165
Last Updated: 2024-05-30
Results Overview
Participants walking up and down a 100 foot hallway for six minutes following a standardized protocol. The goal is for them to walk as far as possible in six minutes
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Change from baseline to six-month follow-up in six-minute walk distance
Results posted on
2024-05-30
Participant Flow
Participant milestones
| Measure |
Placebo
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
3-month Follow-up
STARTED
|
18
|
21
|
|
3-month Follow-up
COMPLETED
|
18
|
20
|
|
3-month Follow-up
NOT COMPLETED
|
0
|
1
|
|
6-month Follow-up
STARTED
|
18
|
21
|
|
6-month Follow-up
COMPLETED
|
17
|
19
|
|
6-month Follow-up
NOT COMPLETED
|
1
|
2
|
|
12-month Follow-up
STARTED
|
18
|
21
|
|
12-month Follow-up
COMPLETED
|
16
|
19
|
|
12-month Follow-up
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
3-month Follow-up
Death
|
0
|
1
|
|
6-month Follow-up
Death
|
0
|
1
|
|
6-month Follow-up
Withdrawal by Subject
|
1
|
1
|
|
12-month Follow-up
Death
|
1
|
1
|
|
12-month Follow-up
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Hepatocyte Growth Factor to Improve Functioning in PAD
Baseline characteristics by cohort
| Measure |
VM202
n=21 Participants
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
Placebo
n=18 Participants
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.9 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
67.1 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
69.1 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ankle Brachial Index
|
0.61 ratio of systolic pressures
STANDARD_DEVIATION 0.12 • n=5 Participants
|
0.63 ratio of systolic pressures
STANDARD_DEVIATION 0.13 • n=7 Participants
|
0.62 ratio of systolic pressures
STANDARD_DEVIATION 0.12 • n=5 Participants
|
|
Body Mass Index
|
29.8 kg/m^2
STANDARD_DEVIATION 6.4 • n=5 Participants
|
30.0 kg/m^2
STANDARD_DEVIATION 5.6 • n=7 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Six-minute walk distance
|
321.7 meters
STANDARD_DEVIATION 72.2 • n=5 Participants
|
310.2 meters
STANDARD_DEVIATION 77.9 • n=7 Participants
|
316.4 meters
STANDARD_DEVIATION 74.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to six-month follow-up in six-minute walk distanceParticipants walking up and down a 100 foot hallway for six minutes following a standardized protocol. The goal is for them to walk as far as possible in six minutes
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
n=19 Participants
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
Six-minute Walk Distance
|
17.01 meters
Standard Error 13.76
|
3.46 meters
Standard Error 12.70
|
SECONDARY outcome
Timeframe: Change from baseline to three-month follow-upA Gardner or Modified Gardner treadmill exercise protocol will be used
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
n=10 Participants
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
Maximal Treadmill Walking Time
|
-0.59 minutes
Standard Error 0.73
|
1.66 minutes
Standard Error 0.73
|
SECONDARY outcome
Timeframe: Change from baseline to three-month follow-upCalf muscle perfusion is measured by Magnetic Resonance Imaging (MRI) Unit of measure is ml/minute per 100 gms tissue
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
n=7 Participants
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
Calf Muscle Perfusion
|
1.98 ml/minute per 100 gm tissue
Standard Error 1.90
|
2.68 ml/minute per 100 gm tissue
Standard Error 1.87
|
SECONDARY outcome
Timeframe: Change from baseline to three-month follow-upA skeletal muscle sample will be obtained from the calf muscle. The outcome is the number of satellite cells per 100 muscle fibers
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
n=7 Participants
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
Calf Muscle Biopsy Biochemical Measures (Satellite Cells - Total SCs/100 Fibers)
|
-4.83 Satellite cells per 100 muscle fibers
Standard Error 8.23
|
3.45 Satellite cells per 100 muscle fibers
Standard Error 6.91
|
SECONDARY outcome
Timeframe: Change from baseline to three-month follow-upThe well validated Walking Impairment Questionnaire will be used to measure patient- perceived walking performance. The WIQ is scored from 0-100, with 100 being the best score. We will use distance and speed sub-components separately.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
n=20 Participants
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
Walking Impairment Questionnaire - Distance Score
|
6.28 score on a scale
Standard Error 5.54
|
8.30 score on a scale
Standard Error 5.19
|
SECONDARY outcome
Timeframe: Change from baseline to three-month follow-upThis well validated quality of life measure will be used to assess changes in patient perceived quality of life. The SF-36 is scored from 0-100, with 100 being the best score.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
n=20 Participants
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
The Short-Form-36 Physical Functioning Score
|
8.70 score on a scale
Standard Error 4.94
|
3.20 score on a scale
Standard Error 4.60
|
SECONDARY outcome
Timeframe: Change from baseline to six-month follow-upThis well validated quality of life measure will be used to assess changes in patient perceived quality of life. Scored on a 0-100 scale, where 100- is best.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
n=20 Participants
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
The Short-Form-36 Physical Functioning Score
|
11.98 score on a scale
Standard Error 3.67
|
6.84 score on a scale
Standard Error 3.32
|
SECONDARY outcome
Timeframe: Change from baseline to six-month follow-upThe well validated Walking Impairment Questionnaire will be used to measure patient- perceived walking performance.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
n=20 Participants
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
Walking Impairment Questionnaire - Distance Score
|
11.44 score on a scale
Standard Error 6.63
|
9.31 score on a scale
Standard Error 6.01
|
SECONDARY outcome
Timeframe: Change in six-minute walk distance from baseline to three-month follow-upParticipants walking up and down a 100 foot hallway for six minutes following a standardized protocol. The goal is for them to walk as far as possible in six minutes
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
n=20 Participants
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
Six-minute Walk Distance
|
-0.48 meters
Standard Error 12.80
|
-2.49 meters
Standard Error 12.01
|
SECONDARY outcome
Timeframe: Change from baseline to three-month follow-upA Gardner or Modified Gardner treadmill exercise protocol will be used
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
n=10 Participants
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
Pain-free Treadmill Walking Time
|
0.95 minutes
Standard Error 0.80
|
0.45 minutes
Standard Error 0.77
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 12-month follow-up in six minute walk distance.See above regarding 6-minute walk protocol
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
n=18 Participants
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
Six-minute Walk Distance
|
5.02 meters
Standard Error 12.17
|
2.24 meters
Standard Error 11.17
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 14 other events
Deaths: 1 deaths
VM202
Serious events: 6 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=18 participants at risk
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
n=21 participants at risk
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
16.7%
3/18 • Number of events 6 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
0.00%
0/21 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Lower extremity revascularization
|
0.00%
0/18 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
4.8%
1/21 • Number of events 1 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Chest pain
|
5.6%
1/18 • Number of events 1 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
0.00%
0/21 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Fall and fracture
|
0.00%
0/18 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
4.8%
1/21 • Number of events 1 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Dehydration
|
5.6%
1/18 • Number of events 1 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
0.00%
0/21 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Bowel obstruction
|
5.6%
1/18 • Number of events 1 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
0.00%
0/21 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Colonoscopy
|
5.6%
1/18 • Number of events 1 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
0.00%
0/21 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Palpitations and anemia
|
0.00%
0/18 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
4.8%
1/21 • Number of events 1 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Blood transfusion/anemia
|
0.00%
0/18 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
4.8%
1/21 • Number of events 1 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
0.00%
0/18 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
4.8%
1/21 • Number of events 1 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Pulled muscle
|
0.00%
0/18 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
4.8%
1/21 • Number of events 1 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Hypertension
|
0.00%
0/18 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
4.8%
1/21 • Number of events 1 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
COPD exacerbation
|
5.6%
1/18 • Number of events 1 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
0.00%
0/21 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Lower extremity arterial bypass surgery
|
0.00%
0/18 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
4.8%
1/21 • Number of events 1 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
Other adverse events
| Measure |
Placebo
n=18 participants at risk
Participants will receive injections of placebo in calf skeletal muscle every 14 days for a total of four treatment days.
Placebo: Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
VM202
n=21 participants at risk
Participants will receive injections of VM202 (4 mgs) in calf skeletal muscle every 14 days for a total of four treatment days.
VM202: Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
|
|---|---|---|
|
General disorders
Pain or discomfort at the study drug injection sites
|
38.9%
7/18 • Number of events 8 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
61.9%
13/21 • Number of events 24 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Redness or irritation at the study drug injection sites
|
16.7%
3/18 • Number of events 3 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
19.0%
4/21 • Number of events 6 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Diagnosed with infection at any of the injection sites
|
0.00%
0/18 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
0.00%
0/21 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Venous thromboembolism (deep venous thrombosis or pulmonary embolism)
|
0.00%
0/18 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
9.5%
2/21 • Number of events 2 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Eye disease - proliferative retinopathy
|
0.00%
0/18 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
0.00%
0/21 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Diagnosed with a new tumor or cancer
|
0.00%
0/18 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
0.00%
0/21 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
|
General disorders
Stayed overnight in the hospital
|
33.3%
6/18 • Number of events 8 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
23.8%
5/21 • Number of events 5 • Adverse events forms are collected at 2nd, 3rd, and 4th injection days, as well as the 3-month, 6-month, and 12-month follow-up visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place