Abstract
Critical limb ischemia (CLI) is a potentially life-threatening condition that involves severely reduced blood flow to the peripheral arteries due to arteriosclerosis obliterans (ASO) of the limbs or a similar condition. CLI patients must undergo revascularization to avoid amputation of the lower limbs and improve their survival prognosis. However, the outcomes of conventional surgical revascularization or endovascular therapy are inadequate; therefore, establishing further effective treatment methods is an urgent task. We perform therapeutic angiogenesis using autologous bone marrow-derived mononuclear cells in clinical practice and demonstrated its safety and efficacy for CLI patients for whom conventional treatments failed or are not indicated. Exercise therapies must be devised for CLI patients who have undergone therapeutic angiogenesis to save their limbs and improve survival. Because evidence regarding the efficacy and safety of exercise therapy for CLI patients is lacking, we plan to perform a prospective trial of the efficacy and safety of optimal exercise therapy following therapeutic angiogenesis for CLI patients.The trial will enroll 30 patients between 20 and 79 years with Rutherford category 4 or 5 CLI caused by ASO who will undergo therapeutic angiogenesis. Participants will be randomly allocated to receive either optimal exercise therapy or fixed exercise therapy. Those receiving optimal exercise therapy will undergo tissue muscle oxygen saturation monitoring using near-infrared spectroscopy while performing exercises and will be prescribed optimal exercise therapy. The optimal amount of exercise will be determined on day 8, 31, 61, 91 and 181 after therapeutic angiogenesis. Ethics and disseminationThis protocol was approved by the Institutional Review Boards of Kyoto Prefectural University of Medicine. In accordance with the Helsinki Declaration, written informed consent has been obtained from all participants prior to enrollment. The results of this trial will be disseminated by publication in a peer-reviewed journal. Trial registrationThis trial is registered at http://www.umin.ac.jp/ctr/index.htm (identifier: UMIN000035288).
Highlights
Critical limb ischemia (CLI) is the end stage of peripheral artery disease (PAD), which occurs when peripheral artery stenosis or occlu sion severely reduces blood flow, thereby causing the appearance of resting pain, gangrene and ulceration of the limbs
Therapeutic angiogenesis using autologous bone marrow-derived mononuclear cells (BM-MNC) had been undertaken in clinical practice and demonstrated its safety and efficacy for no-option CLI patients caused by arteriosclerosis obliterans (ASO), thromboangiitis obliterans (TAO), and vasculitis due to collagen diseases for whom conventional treatments failed or are not indicated [2,3,4,5,6,7]
The long-term survival rate and limb salvage rate were lower in CLI patients associated with ASO after therapeutic angiogenesis compared to those associated with TAO or collagen diseases [7]
Summary
Critical limb ischemia (CLI) is the end stage of peripheral artery disease (PAD), which occurs when peripheral artery stenosis or occlu sion severely reduces blood flow, thereby causing the appearance of resting pain, gangrene and ulceration of the limbs. Therapeutic angiogenesis using autologous bone marrow-derived mononuclear cells (BM-MNC) had been undertaken in clinical practice and demonstrated its safety and efficacy for no-option CLI patients caused by ASO, TAO, and vasculitis due to collagen diseases for whom conventional treatments failed or are not indicated [2,3,4,5,6,7]. The long-term survival rate and limb salvage rate were lower in CLI patients associated with ASO after therapeutic angiogenesis compared to those associated with TAO or collagen diseases [7]. We should establish appropriate exercise intensity and frequency that do not lead deterioration of lower extremity ischemia and wound for CLI pa tients after therapeutic angiogenesis. We have planned a clinical trial to identify the direct efficacy of appropriate exercise therapy for limb ischemia for patients who have undergone therapeutic angiogenesis
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