Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 1:13 AM
Study NCT ID:
NCT01173094
Status:
UNKNOWN
Last Update Posted:
2012-12-24
First Post:
2010-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part II) (DCLI-II)
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
DCLI-II:Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part II)
Status:
UNKNOWN
Status Verified Date:
2010-07
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DCLI-II
Brief Summary:
The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.
Detailed Description:
The trial includes two parts and here is part II. This part is a multi-center, prospective, registration study which focuses on the treatment of below-knee arterial lesion. Totally 130 patients will be entered into this part. They should suffer ischemic symptom with Rutherford 3-6 for the occlusion of the below-knee arteries(anterior tibialăposterior tibial or peroneal artery). According to the lesion length, the patients will accept transluminal angioplasty or below-knee arterial bypass. They will be followed up for 3 years. Study examinations will be done at screening, procedure time, 1, 6, 12, 24 and 36 months after procedure.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: