NCT00922389

Brief Summary

The purpose of this study is to determine whether the method (implanting stem cells derived from peripheral blood after G-CSF mobilization) of treatment is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the Sevier pain of ischemia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 17, 2009

Status Verified

June 1, 2009

Enrollment Period

6 months

First QC Date

June 16, 2009

Last Update Submit

June 16, 2009

Conditions

Diabetic FootCritical Limb IschemiaLeg Ulcers

Keywords

Diabetes ComplicationsLower limb ischemiaAdult stem cellsperipheral blood stem cells

Outcome Measures

Primary Outcomes (1)

  • Adverse events and laboratory parameters

    12 Months after the theraphy

Secondary Outcomes (1)

  • Trans Cutaneous partial pressure of Oxygen: TCpO2

    12 Months post thraphy

Study Arms (3)

G-CSF + Stem cells

EXPERIMENTAL
Procedure: will receive G-CSF and peripheral blood derived mononuclear cells

No stem cell group

OTHER
Drug: G-CSF

Standerd theraphy

ACTIVE COMPARATOR

Any therapy for diabetic foot CLI which is routinely practiced and accepted in India

Drug: Standard Therapy

Interventions

will receive G-CSF and peripheral blood derived mononuclear cellsPROCEDURE

Multiple intra muscular implantation of mononuclear stem cells derived from peripheral blood after G-CSF (granulocyte colony-stimulating factor)mobilization in either of two individual dose ranges which would be given to equal number of subjects.

G-CSF + Stem cells
G-CSFDRUG

5 micrograms/kg/day for 4 days by subcutaneous route

No stem cell group
Standard TherapyDRUG

Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc

Standerd theraphy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic patients with controlled blood sugar levels
  • Subject has an Ankle-brachial index \< 0.6
  • TCpO2 \< 30-45 mm Hg measured at the calf muscle
  • Subjects with unilateral or bilateral diabetic critical limb ischemia (reduced TCpO2 (\<30-45 mm Hg)) who are:
  • Non reconstructable PAD as assessed by a qualified vascular surgeon on case to case basis depending upon results of angiography and clinical judgment.
  • Subjects not likely to be benefited with prostaglandin E1
  • Lower extremity Ulcers of Grade II of Wagner's classification
  • All subjects test negative for human immunodeficiency virus, hepatitis B virus, hepatitis C virus and treponema pallidum and their respective antibodies
  • S Creatinine \< 2.5 mg/dL
  • All female participants in the study should be practicing a medically acceptable form of contraception (IUD, the pill etc.)
  • Subject has had previous conservative treatment which resulted in little or no improvement
  • Subject has had no stem cell treatment within the past 6 months o Subject is competent to provide informed consent and follow study procedures and instructions

You may not qualify if:

  • All the subject below age 18 years and above 65 years.
  • The presence of Ischemic ulcers with infectious symptoms anywhere on the lower extremity (Grade 3 and above of Wagner classification would be excluded from the study in the screening period)
  • Diabetes mellitis with HbA1c \> 8.5% or associated with proliferative retinopathy
  • Any past or present malignancy
  • Susceptibility to severe allergic reactions or a history of severe allergic reactions
  • Recent occurrence (within 3 months) of myocardial infarction or brain infarction
  • Coronary angioplasty within the past 1 year
  • Atrial fibrillation or presence of mechanical mitral prosthetic valve
  • Presence of uncontrolled systemic infection or its ongoing treatment
  • Existing vital organ dysfunctions, including heart, lung or kidneys
  • Coagulation disorders such as hemophilia, etc
  • Use of any medication relevant to revascularization or perfusion
  • Lactating female with a breastfeeding child
  • A positive pregnancy test in female subjects
  • A presence of any other significant medical risk or a suspicion of future non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fortis FLT.LT.Rajan Dhall Hospital

New Delhi, National Capital Territory of Delhi, 110 070, India

Location

MeSH Terms

Conditions

Diabetic FootChronic Limb-Threatening IschemiaLeg UlcerDiabetes Complications

Interventions

Granulocyte Colony-Stimulating FactorStandard of Care

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesPeripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Dr. Anoop Misra, MD

    Fortis FLT.LT.Rajan Dhall Hospital ,New Delhi, India

    PRINCIPAL INVESTIGATOR

  • Dr.DAI .

    Beike Biotech

    STUDY DIRECTOR

Central Study Contacts

Dr.Kumar Ramsamudara

CONTACT

0091 11 29552056drkumar@ensindia.com

Dr.Prateek Gupta

CONTACT

0091 11 29552056drprateek@ensindia.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 16, 2009

First Posted

June 17, 2009

Study Start

July 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2011

Last Updated

June 17, 2009

Record last verified: 2009-06

Locations

IN(1)