## Protocol Section
### Identification Module
**NCT ID:** NCT02796079

**Brief Title:** A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications

**Official Title:** A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications

#### Organization Study ID Info
**ID:** ThirdSouthernMedical
#### Organization
**Class:** OTHER_GOV
**Full Name:** The Third Affiliated Hospital of Southern Medical University
### Status Module
#### Completion Date
**Date:** 2018-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2017-04-06

**Type:** ACTUAL

**Last Update Submit Date:** 2017-04-04

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2017-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-01

**Status Verified Date:** 2017-04

#### Study First Post Date
**Date:** 2016-06-10
**Type:** ESTIMATED
**Study First Submit Date:** 2016-05-30
**Study First Submit QC Date:** 2016-06-06
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Nanfang Hospital, Southern Medical University

**Class:** INDUSTRY

**Name:** Academy Military Medical Science, China

**Class:** OTHER

**Name:** The Fifth Affiliated Hospital of Southern Medical University

**Class:** OTHER

**Name:** Southern Medical University, China

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Jie Shen

#### Responsible Party

**Investigator Affiliation:** The Third Affiliated Hospital of Southern Medical University

**Investigator Full Name:** Jie Shen

**Investigator Title:** doctor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

**Detailed Description:** Diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments.

Stem cell therapy has been a new and effective therapy in recent years for diabetic foot. Combined with the previous studies of our research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

### Conditions Module

**Conditions:**

- Peripheral Vascular Disease

- Ischemia

- Diabetic Foot

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 240

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Mesenchymal stem cells derived from bone marrow infusion

**Intervention Names:**

- Biological: mesenchymal stem cells

**Label:** Autologous Bone Marrow Stem Cell

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** saline injections

**Intervention Names:**

- Biological: saline

**Label:** saline

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Autologous Bone Marrow Stem Cell

**Description:** stem cell acquisition, processing and reinfection, to evaluate the efficacy by using autologous bone marrow stem cell

**Name:** mesenchymal stem cells

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- saline

**Description:** saline injections

**Name:** saline

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.

**Measure:** Area of diabetic foot ulcers

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** Improvement of local perfusion.

**Measure:** Improvement of transcutaneous oxygen partial pressure (TcPO2)

**Time Frame:** 3 months

**Measure:** Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)

**Time Frame:** 3 months

**Description:** Measure of the subjective symptom of pain.

**Measure:** Pain (Visual-Analog Scale)

**Time Frame:** 3 months

**Measure:** Walking distance (treadmill) if possible

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diabetes mellitus Type 2 or Type 1
* Age between 18-80 years
* Chronic foot ulcer more than 6 weeks
* No sufficient response to best standard care delivered for six weeks.
* PAD up to Fontaine stage III or IV period
* CLI with the ankle brachial index (index ankle-brachial, ABI) \<0.7 and (or) the percutaneous oxygen partial pressure (oxygen tension transcutaneous, TcPO2) \<30mmHg

Exclusion Criteria:

* HbA1c \>12%
* Hemoglobin \<10 mg/dl
* Creatinine clearance rate \<30ml/min
* Systemic bacterial, viral infections (Mei Du, hepatitis, cytomegalovirus infection, HIV, B19 infection, herpes virus infection) and sepsis
* Have accepted the treatment of stem cells or growth factors
* Have a history of malignant disease
* Pregnancy
* Mental illness history
* Abnormal coagulation function
* Allergic reaction
* Severe cardiac insufficiency (III-IV NYHA)
* Using vasoactive substances

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** shenjiedr@163.com

**Name:** Jie Shen

**Phone:** +86 13808893818

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Email:** Zq1979@smu.edu.cn

- **Name:** Zhang Qun

- **Phone:** 020-62784060

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jie Shen

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** the Third Affiliated Hospital of Southern Medical University

**State:** Guangdong

**Status:** RECRUITING

**Zip:** 510515

#### Overall Officials

**Official 1:**

**Affiliation:** The Third Affiliated Hospital of Southern Medical University

**Name:** Jie Shen

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003925

- Term: Diabetic Angiopathies

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000016523

- Term: Foot Ulcer

- ID: D000007871

- Term: Leg Ulcer

- ID: D000012883

- Term: Skin Ulcer

- ID: D000012871

- Term: Skin Diseases

- ID: D000048909

- Term: Diabetes Complications

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000003929

- Term: Diabetic Neuropathies

- ID: D000050197

- Term: Atherosclerosis

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: HIGH

- As Found: Vascular Disease

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M29213

- Name: Peripheral Arterial Disease

- Relevance: HIGH

- As Found: Peripheral Vascular Disease

- ID: M18894

- Name: Peripheral Vascular Diseases

- Relevance: HIGH

- As Found: Peripheral Vascular Disease

- ID: M19933

- Name: Diabetic Foot

- Relevance: HIGH

- As Found: Diabetic Foot

- ID: M7120

- Name: Diabetic Angiopathies

- Relevance: LOW

- As Found: Unknown

- ID: M17206

- Name: Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M18919

- Name: Foot Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M10883

- Name: Leg Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15686

- Name: Skin Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26004

- Name: Diabetes Complications

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7124

- Name: Diabetic Neuropathies

- 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

### Condition Browse Module - Meshes

- ID: D000017719

- Term: Diabetic Foot

- ID: D000014652

- Term: Vascular Diseases

- ID: D000016491

- Term: Peripheral Vascular Diseases

- ID: D000058729

- Term: Peripheral Arterial Disease

### Misc Info Module

- Version Holder: 2024-05-24
