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Clinical Trials/EUCTR2012-001019-22-FI
EUCTR2012-001019-22-FI
Active, Not Recruiting
N/A

Treatment of chronic critical lower limb ischemia with combination of surgical bypass operation and adenoviral VEGF-DdNdC intramuscular gene transfer A Randomized Single-Blinded Placebo-controlled Phase I-II Clinical Trial - KAT-PAD101

A.I.Virtanen Insitute, University of Kuopio0 sitesAugust 15, 2012
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Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
A.I.Virtanen Insitute, University of Kuopio
Status
Active, Not Recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 15, 2012
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
A.I.Virtanen Insitute, University of Kuopio

Eligibility Criteria

Inclusion Criteria

  • •informed consent signed, age over 60 years, chronic critical leg ischemia according to Rutherford and Fontaine classification (ischemic rest pain and regular requirement of analgesic and/or ischemic ulcer and/or toe gangrene) caused by severe PAOD, femoropopliteal or femorodistal surgical bypass is considered the most suitable treatment option as according to angiographic studies or MRA, palpable pulse in arteria femoralis communis in the operable leg, no prior proximal (thigh or femoral) amputation, stable pain or ischemic tissue lesion for at lest 2 weeks
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 30

Exclusion Criteria

  • •patients with: acute limb ischemia, spreading leg infection, history or suspicion of malignant tumor, chronic immunosuppressive therapy, renal insuffiency (creatinin \> 160 mg/l), NYHA 3\-4 coronary artery disease, previous angiogenic growth factor / gene therapy, and patients that are not eligible for surgical bypass operation for any other reason

Outcomes

Primary Outcomes

Not specified

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