A Clinical Study Using Adipose-derived Stem Cells for Diabetic Foot

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02831075

Enrollment

240

Registered

2016-07-13

Start date

2015-01-31

Completion date

2018-12-31

Last updated

2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot, Ischemia, Peripheral Vascular Disease

Keywords

Adipose-derived Stem Cells

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.

Interventions

BIOLOGICALAdipose-derived stem cell

stem cell acquisition, processing and reinfection, to evaluate the efficacy of adipose-derived stem cell.

BIOLOGICALsaline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Area of diabetic foot ulcers	3 months	To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.

Secondary

Measure	Time frame	Description
Improvement of transcutaneous oxygen partial pressure (TcPO2)	3 months	Improvement of local perfusion.
Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)	3 months	—
Pain (Visual-Analog Scale)	3 months	Measure of the subjective symptom of pain.
Walking distance (treadmill) if possible	3 months	—

Countries

China

Contacts

Primary ContactJie Shen

shenjiedr@163.com+86 13808893818

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026