Trial Outcomes & Findings for ACP-01 in Patients With Critical Limb Ischemia (NCT NCT02551679)
NCT ID: NCT02551679
Last Updated: 2023-11-28
Results Overview
Number of subject with doubling of wound size, major amputation or death
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
Baseline vs. 1 year
Results posted on
2023-11-28
Participant Flow
Participant milestones
| Measure |
ACP-01
Injection into lower extremity
ACP-01: Injection into lower extremity
|
Placebo
Injection into lower extremity
Placebo: Injection into lower extremity
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
21
|
|
Overall Study
COMPLETED
|
27
|
19
|
|
Overall Study
NOT COMPLETED
|
19
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ACP-01 in Patients With Critical Limb Ischemia
Baseline characteristics by cohort
| Measure |
ACP-01
n=46 Participants
Injection into lower extremity
ACP-01: Injection into lower extremity
|
Placebo
n=21 Participants
Injection into lower extremity
Placebo: Injection into lower extremity
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 13.19 • n=5 Participants
|
72 years
STANDARD_DEVIATION 9.86 • n=7 Participants
|
70.9 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
42 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
|
1 Participants
n=7 Participants
|
1 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
61 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
16 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline vs. 1 yearPopulation: The primary endpoint was time from treatment to either de-novo gangrene in the treated limb, or doubling of wound size in the treated limb, or major amputation in the treated limb, or death.
Number of subject with doubling of wound size, major amputation or death
Outcome measures
| Measure |
ACP-01
n=46 Participants
Injection into lower extremity
ACP-01: Injection into lower extremity
The primary endpoint was time from treatment to either de-novo gangrene in the treated limb, or doubling of wound size in the treated limb, or major amputation in the treated limb, or death. The primary outcome was analyzed using a Cox proportional hazards model to generate an HR adjusted for recruitment site. Kaplan-Meier survival curves were created for visual presentation of time-to-event comparisons. For subjects who were lost to follow-up or completed 12 months study visit without a study event, the time to event was censored by the subject's last follow-up date in the study.
|
Placebo
n=21 Participants
Injection into lower extremity
Placebo: Injection into lower extremity
The primary endpoint was time from treatment to either de-novo gangrene in the treated limb, or doubling of wound size in the treated limb, or major amputation in the treated limb, or death. The primary outcome was analyzed using a Cox proportional hazards model to generate an HR adjusted for recruitment site. Kaplan-Meier survival curves were created for visual presentation of time-to-event comparisons. For subjects who were lost to follow-up or completed 12 months study visit without a study event, the time to event was censored by the subject's last follow-up date in the study.
|
|---|---|---|
|
Wound Size, Amputation or Survival
|
12 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline vs. 1 yearChange in pain score according to the Visual Analog Scale (VAS) for Pain. The visual VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the subjects' marks are recorded in centimeters and are interpreted as their pain. The values ar used to track pain progression for a subject and to compare pain between subjects.
Outcome measures
| Measure |
ACP-01
n=46 Participants
Injection into lower extremity
ACP-01: Injection into lower extremity
The primary endpoint was time from treatment to either de-novo gangrene in the treated limb, or doubling of wound size in the treated limb, or major amputation in the treated limb, or death. The primary outcome was analyzed using a Cox proportional hazards model to generate an HR adjusted for recruitment site. Kaplan-Meier survival curves were created for visual presentation of time-to-event comparisons. For subjects who were lost to follow-up or completed 12 months study visit without a study event, the time to event was censored by the subject's last follow-up date in the study.
|
Placebo
n=21 Participants
Injection into lower extremity
Placebo: Injection into lower extremity
The primary endpoint was time from treatment to either de-novo gangrene in the treated limb, or doubling of wound size in the treated limb, or major amputation in the treated limb, or death. The primary outcome was analyzed using a Cox proportional hazards model to generate an HR adjusted for recruitment site. Kaplan-Meier survival curves were created for visual presentation of time-to-event comparisons. For subjects who were lost to follow-up or completed 12 months study visit without a study event, the time to event was censored by the subject's last follow-up date in the study.
|
|---|---|---|
|
Pain Level
|
38.75 units on a scale
Standard Error 9.479
|
44.44 units on a scale
Standard Error 14.036
|
SECONDARY outcome
Timeframe: Baseline vs. 1 yearChange in ulcer size
Outcome measures
| Measure |
ACP-01
n=46 Participants
Injection into lower extremity
ACP-01: Injection into lower extremity
The primary endpoint was time from treatment to either de-novo gangrene in the treated limb, or doubling of wound size in the treated limb, or major amputation in the treated limb, or death. The primary outcome was analyzed using a Cox proportional hazards model to generate an HR adjusted for recruitment site. Kaplan-Meier survival curves were created for visual presentation of time-to-event comparisons. For subjects who were lost to follow-up or completed 12 months study visit without a study event, the time to event was censored by the subject's last follow-up date in the study.
|
Placebo
n=21 Participants
Injection into lower extremity
Placebo: Injection into lower extremity
The primary endpoint was time from treatment to either de-novo gangrene in the treated limb, or doubling of wound size in the treated limb, or major amputation in the treated limb, or death. The primary outcome was analyzed using a Cox proportional hazards model to generate an HR adjusted for recruitment site. Kaplan-Meier survival curves were created for visual presentation of time-to-event comparisons. For subjects who were lost to follow-up or completed 12 months study visit without a study event, the time to event was censored by the subject's last follow-up date in the study.
|
|---|---|---|
|
Ulcer Size
|
1.6 cm^2
Standard Error 1.07
|
1.8 cm^2
Standard Error 0.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 - 52 wksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 - 52 wksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 - 52 wksChange in quality of life according to the Vascular Quality of Life Questionnaire.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 - 52 wksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 - 52 wksOutcome measures
Outcome data not reported
Adverse Events
ACP-01
Serious events: 2 serious events
Other events: 0 other events
Deaths: 5 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ACP-01
n=46 participants at risk
Injection into lower extremity
ACP-01: Injection into lower extremity
|
Placebo
n=21 participants at risk
Injection into lower extremity
Placebo: Injection into lower extremity
|
|---|---|---|
|
Cardiac disorders
acute myocardial infarction
|
4.3%
2/46 • Number of events 2 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/46 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/46 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiovascular disorder
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Cardiac disorders
Aortic valve stenosis
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Infections and infestations
Gangrene
|
4.3%
2/46 • Number of events 2 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Infections and infestations
Localized infection
|
2.2%
1/46 • Number of events 1 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Infections and infestations
Osteomyelitis
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Infections and infestations
Sepsis
|
4.3%
2/46 • Number of events 2 • 1 year
|
0.00%
0/21 • 1 year
|
|
Infections and infestations
Infection
|
0.00%
0/46 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/46 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Infections and infestations
Vascular stent infection
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60