Intramuscular gene transfer for critical chronic lower limb ischemia Phase I-II clinical trial

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001019-22-FI

Enrollment

Registered

2012-08-15

Start date

2012-10-26

Completion date

Unknown

Last updated

2024-10-28

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

Conditions

Critical Chronic lower limb ischemia MedDRA version: 14.1 Level: LLT Classification code 10058069 Term: Critical limb ischemia System Organ Class: 10047065 - Vascular disorders

Interventions

Product Name: AdVEGF-DdNdC Pharmaceutical Form: Solution for injection INN or Proposed INN: Glycerol CAS Number: 56-81-5 Other descriptive name: GLYCEROL Concentration unit: % percent Concentration ty

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is safety of the AdVEGF-DdNdC gene therapy;Secondary Objective: The secondary objective is efficacy of the AdVEGF-DdNdC gene therapy to improve limb blood flow and tissue recovery;Primary end point(s): Safety parameters (blood samples: clinical chemistry, transgene ELISA, thorax x-rays, clinical assessment);Timepoint(s) of evaluation of this end point: from screening upto 6 months (closing visit)	—

Measure

Time frame

Main Objective: The primary objective is safety of the AdVEGF-DdNdC gene therapy;Secondary Objective: The secondary objective is efficacy of the AdVEGF-DdNdC gene therapy to improve limb blood flow and tissue recovery;Primary end point(s): Safety parameters (blood samples: clinical chemistry, transgene ELISA, thorax x-rays, clinical assessment);Timepoint(s) of evaluation of this end point: from screening upto 6 months (closing visit)

—

Secondary

Measure	Time frame
Secondary end point(s): Improved blood flow (contrast enhanced ultrasound, doppler ultrasound, MRI) and muscle energy metabolism (deoxy-myoglobin magnetic resonance spectroscopy and positron emission tomography) (if available) as well as limb salvage, healing of ischemic ulcers, subjective experience of ischemic rest pain, quality of life (Rand-36) and maximal walking distance ;Timepoint(s) of evaluation of this end point: from screening upto 6 months (closing visit)	—

Measure

Time frame

Secondary end point(s): Improved blood flow (contrast enhanced ultrasound, doppler ultrasound, MRI) and muscle energy metabolism (deoxy-myoglobin magnetic resonance spectroscopy and positron emission tomography) (if available) as well as limb salvage, healing of ischemic ulcers, subjective experience of ischemic rest pain, quality of life (Rand-36) and maximal walking distance ;Timepoint(s) of evaluation of this end point: from screening upto 6 months (closing visit)

—

Countries

Finland

Contacts

Public ContactTrial info /Petra Korpisalo

A.I.Virtanen Institute, University of Kuopio

petra.korpisalo@uef.fi+358403553694

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026