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Vascular DiseasesPhase 4DCLI-IINCT01173094

Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part II) (DCLI-II)

A Phase 4 study testing Percutaneous Transluminal Angioplasty and below-knee arterial bypass in people with Vascular Diseases and Diabetes, run by Peking Union Medical College Hospital at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 75 years
Conditions the study is for
Vascular Diseases, Diabetes
What is being tested?
Percutaneous Transluminal Angioplasty and below-knee arterial bypass
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
3 sitesChina
Study dates
Aug 2010to Jul 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patients volunteer to join the trial and sign the formal consent.
  • The patients are ≥55 year-old and ≤75 year-old.
  • The patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or 6.
  • Obvious stenosis or occlusion in below-knee popliteal artery
  • No obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured.
  • No surgical contraindications;no infection in operation region.
  • Be diagnosed with DM for at least 1 year.

Who cannot join

  • Refuse random treatment.
  • Previous operations on the target artery.
  • Acute lower extremity arterial thrombosis.
  • Serious major organ failure.
  • Allergic to the contrast agent or has contrast nephropathy.
  • No clinical compliance or unfit to join the trial

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

  • Xuanwu Hospital, Beijing

    Beijing, Beijing Municipality, 100053

  • Beijing Tongren Hospital

    Beijing, Beijing Municipality, Beijing

Other trials in China

About this study

Official title: DCLI-II:Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part II)

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.

Read the 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 tibial、posterior 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.

Being tested
Percutaneous Transluminal Angioplasty, below-knee arterial bypass
Keywords
Critical limb ischemia, Diabetes Mellitus, Diabetes foot
Medical subject headings
Vascular Diseases, Diabetes Mellitus, Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Transluminal AngioplastyDevice

    Before operation, take aspirin 100mg every day. During the operation, balloon is delivered by a catheter and positioned through the narrowing in the artery. Then expand the balloon against the wall of the blood vessel to provide a wider channel for blood.

  • below-knee arterial bypassDevice

    Before operation, take aspirin 100mg every day. Perform bypass to below-knee(posterior tibial，anterior tibial or peroneal)arteries, saphenous vein graft with end to side anastomoses

Study groups in NCT01173094
Study groupRoleWhat they receive
PTAExperimentalThe patients with short-obstruction in the below-knee artery will be included in this group.
Receives: Device: Percutaneous Transluminal Angioplasty
bypassExperimentalThe patients with long-obstruction in the below-knee artery will be included in this group.
Receives: Device: below-knee arterial bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occlusion of the below-knee artery or bypass

    Measured: 36 months

Secondary outcomes (5)

  1. Mortality

    The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure.

    Measured: 30 days

  2. Rate of limb salvage

    Measured: 36 months

  3. Procedural complications, defined as any adverse event

    including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula

    Measured: 36 months

  4. Quality of Life assessment

    assessment in 1 month,6 months,12 months,24 months and 36 months post procedure

    Measured: 36 months

  5. Restenosis measured by Duplex Ultrasound or CTA

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionJul 2013 (estimated)
  4. Study completionJul 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01173094
Sponsor's protocol ID
pumch-DCLI-II
Acronym
DCLI-II
Status last verified
Jul 2010
First submitted
28 Jul 2010
Last updated
24 Dec 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Percutaneous Transluminal Angioplasty and below-knee arterial bypass in people with Vascular Diseases and Diabetes, run by Peking Union Medical College Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occlusion of the below-knee artery or bypass (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01173094.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2012.

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