## Protocol Section
### Identification Module
**NCT ID:** NCT02551679

**Brief Title:** ACP-01 in Patients With Critical Limb Ischemia

**Official Title:** A Randomized Double Blind Placebo Controlled Clinical Study to Assess Blood-Derived Autologous Angiogenic Cell Precursor Therapy in Patients With Critical Limb Ischemia (ACP-CLI)

**NCT ID Aliases:**
- NCT02140931
#### Organization Study ID Info
**ID:** HS 12-01.
#### Organization
**Class:** INDUSTRY
**Full Name:** Hemostemix
### Status Module
#### Completion Date
**Date:** 2021-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-28

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-04

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-11-18

**Type:** ACTUAL

**Results First Submit Date:** 2023-09-09

**Results First Submit QC Date:** 2023-10-30

#### Start Date
**Date:** 2014-08

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2015-09-16
**Type:** ESTIMATED
**Study First Submit Date:** 2015-09-14
**Study First Submit QC Date:** 2015-09-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hemostemix

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The primary objective of this study is to determine the efficacy and safety of intramuscular injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb ischemia who are receiving standard of care therapy and have no endovascular or surgical revascularization options.

**Detailed Description:** This prospective, randomized, double-blind, placebo controlled study will assess the efficacy and safety of autologous ACPs administered intramuscularly into the lower extremity of subjects with CLI who lack surgical or endovascular revascularization options.

A total of approximately 95 subjects will be randomized to treatment with ACP-01 or placebo using a 2:1 randomization scheme, respectively, stratified by site.

The study will continue until all subjects treated experience the study event (either de novo gangrene, doubling of wound size, major amputation, or death) or are event-free for at least 26 weeks. Subjects treated will be followed for no longer than 52 weeks.

One futility analysis for potentially stopping study enrollment will be performed.

Subjects treated at each investigative site will provide written informed consent prior to the conduct of any study-related procedures. Thereafter, they will be screened and those meeting the inclusion/exclusion criteria will be enrolled into the trial and undergo all the study procedures including intramuscular injection of the investigational medicinal product (IMP = ACP-01 or placebo). The IMP will be administered in addition to any conventional treatment the subject is receiving.

The control group will receive placebo injections into the lower extremity to ensure blinding of the assessors and the subjects.

The placebo will consist of the same medium used in the ACP product suspension.

The study consists of four periods: Screening period, Treatment period, Acute safety follow-up and Long term follow-up periods. The total duration of study participation, including follow-up, is at least 26 weeks. Subjects will be followed for up to 52 weeks and at least until the last subject has completed his/her 26 week visit.

### Conditions Module

**Conditions:**

- Critical Limb Ischemia

**Keywords:**

- Stem cells

- Autologous

- Vascular disease

- Peripheral arterial disease

- Regenerative medicine

- Amputation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 67

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Injection into lower extremity

**Intervention Names:**

- Biological: ACP-01

**Label:** ACP-01

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Injection into lower extremity

**Intervention Names:**

- Biological: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ACP-01

**Description:** Injection into lower extremity

**Name:** ACP-01

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Injection into lower extremity

**Name:** Placebo

**Type:** BIOLOGICAL

### Outcomes Module

#### Other Outcomes

**Measure:** Change From Baseline in the Dose and Quantity of Analgesic Drugs Used by the Subject

**Time Frame:** 1 - 52 wks

**Measure:** Reduction in Total Hospitalization Time of Subjects Treated With ACP-01 Compared to Subjects Treated With Placebo

**Time Frame:** 1 - 52 wks

**Description:** Change in quality of life according to the Vascular Quality of Life Questionnaire.

**Measure:** Change From Baseline in Quality of Life

**Time Frame:** 1 - 52 wks

**Measure:** Change From Baseline in Ankle Pressure

**Time Frame:** 1 - 52 wks

**Measure:** Change From Baseline in Toe Pressure

**Time Frame:** 1 - 52 wks

#### Primary Outcomes

**Description:** Number of subject with doubling of wound size, major amputation or death

**Measure:** Wound Size, Amputation or Survival

**Time Frame:** Baseline vs. 1 year

#### Secondary Outcomes

**Description:** Change 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.

**Measure:** Pain Level

**Time Frame:** Baseline vs. 1 year

**Description:** Change in ulcer size

**Measure:** Ulcer Size

**Time Frame:** Baseline vs. 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subject is diagnosed with critical limb ischemia.
* Subject has hemodynamic indicators of severe peripheral arterial occlusive disease.
* Subject is not a candidate for standard revascularization treatment options for peripheral arterial disease.
* Subject must be on standard of care medical therapy for peripheral vascular disease.
* Male or female age 18 and above.
* Non-pregnant, non-lactating female.
* Subject is able to understand and provide voluntary signed informed consent.

Exclusion Criteria:

* Uncorrected aorto-iliac occlusive disease.
* Subjects who, in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation in a time frame shortly after administration of the IMP (investigational drug or placebo).
* Advanced Critical Limb Ischemia (CLI) presenting as severe ischemic or dry gangrene.
* Lower extremity non-treated active infection.
* Hypercoagulable state.
* Subject received a blood transfusion during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood).
* Inability to communicate that may interfere with clinical evaluation.
* Recent major non-vascular operation.
* Myocardial infarction or uncontrolled myocardial ischemia or persistent severe heart failure.
* Severe aortic stenosis.
* Renal failure.
* Hepatic failure.
* Anemia.
* Major stroke.
* Diagnosis of malignancy.
* Concurrent chronic or acute infectious disease and uncontrolled infectious symptoms.
* Severe concurrent disease (other than Peripheral Vascular Disease (PAD)).
* Bleeding diathesis.
* Participation at the same time in another investigational product or device study.
* Chronic cytotoxic drug treatment.
* Life expectancy of less than 6 months.
* Subject unlikely to be available for follow-up.
* Acute worsening of CLI.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sacramento

**Country:** United States

**Facility:** UC Davis CTSC Clinical Research Center

**State:** California

**Zip:** 95817

**Location 2:**

**City:** Aurora

**Country:** United States

**Facility:** Rocky Mountain Regional VA Medical Center

**State:** Colorado

**Zip:** 80045

**Location 3:**

**City:** Gainesville

**Country:** United States

**Facility:** University of Florida

**State:** Florida

**Zip:** 32610

**Location 4:**

**City:** Miami

**Country:** United States

**Facility:** Clinovation Research, LLC

**State:** Florida

**Zip:** 33126

**Location 5:**

**City:** Winter Haven

**Country:** United States

**Facility:** Clinical Research of Central Florida

**State:** Florida

**Zip:** 33880

**Location 6:**

**City:** Decatur

**Country:** United States

**Facility:** Decatur Memorial Hospital

**State:** Illinois

**Zip:** 62526

**Location 7:**

**City:** Maywood

**Country:** United States

**Facility:** Loyola University Medical Center

**State:** Illinois

**Zip:** 60153

**Location 8:**

**City:** Worcester

**Country:** United States

**Facility:** University of Massachusetts Medical School

**State:** Massachusetts

**Zip:** 01655

**Location 9:**

**City:** Lebanon

**Country:** United States

**Facility:** Dartmouth-Hitchcock Medical Center

**State:** New Hampshire

**Location 10:**

**City:** Greensboro

**Country:** United States

**Facility:** Moses H. Cone Memorial Hospital

**State:** North Carolina

**Zip:** 27401

**Location 11:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Wake Forest Baptist Health

**State:** North Carolina

**Zip:** 27157

**Location 12:**

**City:** Oklahoma City

**Country:** United States

**Facility:** University of Oklahoma Health Sciences Center

**State:** Oklahoma

**Zip:** 73104

**Location 13:**

**City:** Philadelphia

**Country:** United States

**Facility:** Temple University Hosptial

**State:** Pennsylvania

**Zip:** 19140

**Location 14:**

**City:** Charleston

**Country:** United States

**Facility:** Medical University of South Carolina

**State:** South Carolina

**Zip:** 29425

**Location 15:**

**City:** Houston

**Country:** United States

**Facility:** Houston Methodist DeBakey Heart & Vascular Center

**State:** Texas

**Zip:** 77030

**Location 16:**

**City:** San Antonio

**Country:** United States

**Facility:** Clinical Trials of Texas, Inc. (CTT)

**State:** Texas

**Zip:** 78229

**Location 17:**

**City:** Vancouver

**Country:** Canada

**Facility:** Vancouver General Hospital

**State:** British Columbia

**Zip:** V5Z 1K3

**Location 18:**

**City:** London

**Country:** Canada

**Facility:** London Health Sciences Centre

**State:** Ontario

**Zip:** N6A 5W9

**Location 19:**

**City:** Toronto

**Country:** Canada

**Facility:** Toronto General Hospital

**State:** Ontario

**Zip:** M5G 2C4

### References Module

#### See Also Links

**Label:** Hemostemix Inc. website

**URL:** http://www.hemostemix.com

## Document Section

### Large Document Module

#### Large Docs

- Date: 2019-10-18

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 706020

- Type Abbrev: Prot

- Upload Date: 2023-09-09T14:02

- Date: 2021-06-01

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 345491

- Type Abbrev: SAP

- Upload Date: 2023-09-09T14:04

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000058729

- Term: Peripheral Arterial Disease

- ID: D000050197

- Term: Atherosclerosis

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000016491

- Term: Peripheral Vascular Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: HIGH

- As Found: Ischemia

- ID: M2714

- Name: Chronic Limb-Threatening Ischemia

- Relevance: HIGH

- As Found: Critical Limb Ischemia

- ID: M29213

- Name: Peripheral Arterial Disease

- Relevance: LOW

- As Found: Unknown

- ID: M18894

- Name: Peripheral Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26188

- Name: Atherosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000089802

- Term: Chronic Limb-Threatening Ischemia

- ID: D000007511

- Term: Ischemia

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** ACP-01

**Deaths Num Affected:** 5

**Deaths Num At Risk:** 46

**Description:** Injection into lower extremity

ACP-01: Injection into lower extremity

**ID:** EG000

**Other Num at Risk:** 46

**Serious Number Affected:** 2

**Serious Number At Risk:** 46

**Title:** ACP-01

**Group ID:** EG001

**Title:** Placebo

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 21

**Description:** Injection into lower extremity

Placebo: Injection into lower extremity

**ID:** EG001

**Other Num at Risk:** 21

**Serious Number Affected:** 1

**Serious Number At Risk:** 21

**Title:** Placebo

**Frequency Threshold:** 0

#### Serious Events

**Term:** acute myocardial infarction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 46

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 21

**Num Events:** 1

**Term:** Cardiac failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 46

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 21

**Num Events:** 1

**Term:** Cardiac failure congestive

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 46

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 21

**Num Events:** 1

**Term:** Cardiovascular disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 46

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 21

**Term:** Aortic valve stenosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 46

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 21

**Term:** Gangrene

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 46

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 21

**Num Events:** 1

**Term:** Localized infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 46

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 21

**Num Events:** 1

**Term:** Osteomyelitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 46

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 21

**Term:** Sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 46

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 21

**Term:** Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 46

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 21

**Num Events:** 1

**Term:** Pneumonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 46

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 21

**Num Events:** 1

**Term:** Vascular stent infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 46

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 21

**Time Frame:** 1 year

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 46

**Group ID:** BG001

**Value:** 21

**Group ID:** BG002

**Value:** 67

**Units:** Participants

### Group

**ID:** BG000

**Title:** ACP-01

**Description:** Injection into lower extremity

ACP-01: Injection into lower extremity

### Group

**ID:** BG001

**Title:** Placebo

**Description:** Injection into lower extremity

Placebo: Injection into lower extremity

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 14

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 36

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 53

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 13.19

**Value:** 70

#### Measurement

**Group ID:** BG001

**Spread:** 9.86

**Value:** 72

#### Measurement

**Group ID:** BG002

**Spread:** 12.2

**Value:** 70.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 17

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 25

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 29

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 42

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 5

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 43

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 61

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 13

**Class Title:** Canada

#### Measurement

**Group ID:** BG000

**Value:** 38

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 54

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Point of Contact
**Email:** fhenderson@hemostemix.com
**Organization:** Hemostemix
**Phone:** 2022978858
**Title:** Dr. Fraser Henderson
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.577
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 7.255
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** The primary hypothesis of this study is that ACP-01 is superior to placebo in terms of the earlier time from treatment with Investigational Medicinal Product (IMP) to either de-novo gangrene, or doubling of wound size, or major amputation, or death.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.258
**P-Value Comment:** 
**Parameter Type:** Cox Proportional Hazard
**Parameter Value:** 2.046
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.479
- **Upper Limit:** 
- **Value:** 38.75
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 14.036
- **Upper Limit:** 
- **Value:** 44.44
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.07
- **Upper Limit:** 
- **Value:** 1.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.59
- **Upper Limit:** 
- **Value:** 1.8
**Title:** 
#### Outcome Measure 4
#### Outcome Measure 5
#### Outcome Measure 6
#### Outcome Measure 7
#### Outcome Measure 8
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Number of subject with doubling of wound size, major amputation or death
**Parameter Type:** NUMBER
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** Baseline vs. 1 year
**Title:** Wound Size, Amputation or Survival
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** ACP-01
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Description:** Change 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.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline vs. 1 year
**Title:** Pain Level
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Injection into lower extremity

ACP-01: Injection into lower extremity
**ID:** OG000
**Title:** ACP-01
##### Group
**Description:** Injection into lower extremity

Placebo: Injection into lower extremity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Description:** Change in ulcer size
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline vs. 1 year
**Title:** Ulcer Size
**Type:** SECONDARY
**Unit of Measure:** cm^2
##### Group
**Description:** Injection into lower extremity

ACP-01: Injection into lower extremity
**ID:** OG000
**Title:** ACP-01
##### Group
**Description:** Injection into lower extremity

Placebo: Injection into lower extremity
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Reporting Status:** NOT_POSTED
**Time Frame:** 1 - 52 wks
**Title:** Change From Baseline in the Dose and Quantity of Analgesic Drugs Used by the Subject
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 5
**Reporting Status:** NOT_POSTED
**Time Frame:** 1 - 52 wks
**Title:** Reduction in Total Hospitalization Time of Subjects Treated With ACP-01 Compared to Subjects Treated With Placebo
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 6
**Description:** Change in quality of life according to the Vascular Quality of Life Questionnaire.
**Reporting Status:** NOT_POSTED
**Time Frame:** 1 - 52 wks
**Title:** Change From Baseline in Quality of Life
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 7
**Reporting Status:** NOT_POSTED
**Time Frame:** 1 - 52 wks
**Title:** Change From Baseline in Ankle Pressure
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 8
**Reporting Status:** NOT_POSTED
**Time Frame:** 1 - 52 wks
**Title:** Change From Baseline in Toe Pressure
**Type:** OTHER_PRE_SPECIFIED
### Participant Flow Module
#### Group
**Description:** Injection into lower extremity

ACP-01: Injection into lower extremity
**ID:** FG000
**Title:** ACP-01
#### Group
**Description:** Injection into lower extremity

Placebo: Injection into lower extremity
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 46
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 21
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 27
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 19
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 19
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
**Has Results:** True