Emerging treatments

Gene transfer

Intramuscular injections of vascular endothelial growth factor have had some encouraging preliminary results at improving collateral vessel formation.[52] One study of patients with critical limb ischemia (including 10 patients with Buerger disease) found a sustained decrease in ischemic ulcer size in the hepatocyte growth factor gene therapy group after 12 weeks.[53] However, resting pain on a visual analog scale was not significantly improved compared with placebo.

Autologous bone marrow cell transplantation

Implantation of autologous bone marrow cells by multiple injections into the gastrocnemius muscle may increase collateral vessel formation. Improved ankle-brachial index, transcutaneous oxygen concentration, rest pain, pain-free walking distance, ulcer healing, and limb salvage has been reported.[54][55] Autologous bone marrow mononuclear cell (BM-MNC) implantation has been shown to reduce amputation rates in those unsuitable for angioplasty or surgical revascularization. In a nonrandomized trial, patients with Buerger disease who had rest pain and nonhealing ulcers had a 4-year amputation-free rate of 95% with BM-MNC (n=26) compared with 6% in those who did not receive BM-MNC (n=16).[56] High-quality trials are needed to confirm the safety and efficacy of this treatment.[57]

Bosentan

An endothelin receptor antagonist reported to improve digital necrosis.[58] In one meta-analysis of patients with Buerger disease refractory to conventional treatment, a complete therapeutic response was achieved in 80% of patients treated with bosentan; 12% achieved a partial response.[59]

Guanethidine

Reduces catecholamine release by acting on the Na+-ATPase-dependent pump. Reduction of rest pain and ulceration healing have been reported with guanethidine injections into the affected limb, sometimes with the additional use of a Bier block (intravenous regional sympathetic blockade).[60][61] Injections can be easily repeated if beneficial effects are seen. Data on the effectiveness of guanethidine are limited, and it is not available in many countries, including the US.

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