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Updated: Apr 5, 2026

Osmotic Drug Delivery to Ischemic Hindlimbs and Perfusion of Vasculature with Microfil for Micro-Computed Tomography Imaging
Published on: June 29, 2013
Current Phase II drugs under investigation for the treatment of limb ischemia
Stavros Spiliopoulos1, Panagiotis Kitrou1, Konstantinos Katsanos2
1a 1 Patras University Hospital, Department of Interventional Radiology , Patras 26504, Greece +30 2613 603 219; stavspiliop@upatras.gr.
Introduction:
More than 20 million people in Europe suffer from peripheral arterial disease and nearly 3% develop critical limb ischemia (CLI). Without any medical treatment, CLI has poor prognosis, resulting in limb loss and high mortality rate. Until today, no systemic drug is available for the treatment of CLI and the gold standard method of treatment includes risk factor modification and open surgical or endovascular revascularization. Endovascular local drug delivery devices and novel antithrombotic agents, currently under investigation, aim to improve outcomes of revascularization procedures. The pioneering concept of therapeutic angiogenesis induced by gene and stem cell therapy has been proposed, in an attempt to increase ischemic tissue perfusion.
Areas Covered:
This review summarizes local and systemic pharmacological treatment of CLI using endovascular or pharmaco-biological therapy and focuses on Phase II trials available for these drugs.
Expert Opinion:
Novel endovascular technologies combining angioplasty and local drug-delivery continuously improve and will come to be standard of practice for the management of limb ischemia, while new antithrombotic agents will further improve outcomes. Therapeutic angiogenesis represents a safe and promising treatment option. The combination of revascularization with microcirculation improvement induced by gene or stem cell therapy could enhance limb salvage.
Insights
Peripheral arterial disease affects millions, with critical limb ischemia (CLI) leading to amputation. New endovascular treatments and therapeutic angiogenesis show promise for improving limb salvage and patient outcomes.
Area of Science:
- Vascular Medicine
- Interventional Cardiology
- Regenerative Medicine
Background:
- Peripheral arterial disease (PAD) affects over 20 million Europeans, with critical limb ischemia (CLI) posing significant risks.
- CLI has a poor prognosis without treatment, often leading to limb loss and high mortality.
- Current gold standard treatments involve risk factor modification and revascularization, with limited systemic pharmacological options.
Purpose of the Study:
- To review current local and systemic pharmacological treatments for CLI.
- To focus on Phase II clinical trials for novel CLI therapies.
- To explore emerging strategies like therapeutic angiogenesis.
Main Methods:
- Systematic review of literature on endovascular and pharmaco-biological therapies for CLI.
- Analysis of Phase II clinical trial data for pharmacological agents.
- Evaluation of gene and stem cell therapy concepts for therapeutic angiogenesis.
Main Results:
- Novel endovascular technologies combining angioplasty with local drug delivery are advancing treatment standards.
- New antithrombotic agents are expected to further enhance revascularization outcomes.
- Therapeutic angiogenesis, via gene and stem cell therapy, shows potential for increasing ischemic tissue perfusion.
Conclusions:
- Endovascular innovations and local drug delivery are becoming standard for limb ischemia management.
- Antithrombotic agents and therapeutic angiogenesis offer promising avenues for improving limb salvage.
- Combining revascularization with microcirculation enhancement through gene or stem cell therapy could significantly improve outcomes.
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