Emerging treatments
Gene transfer
Intramuscular injections of vascular endothelial growth factor have had some encouraging preliminary results at improving collateral vessel formation.[54] One study of patients with critical limb ischaemia (including 10 patients with Buerger’s disease) found a sustained decrease in ischaemic ulcer size in the hepatocyte growth factor gene therapy group after 12 weeks.[55] However, resting pain on a visual analogue 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.[56][57] Autologous bone marrow mononuclear cell (BM-MNC) implantation has been shown to reduce amputation rates in those unsuitable for angioplasty or surgical revascularisation. In a non-randomised trial, patients with Buerger's disease who had rest pain and non-healing 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).[58] High-quality trials are needed to confirm the safety and efficacy of this treatment.[59]
Bosentan
An endothelin receptor antagonist reported to improve digital necrosis.[60] In one meta-analysis of patients with Buerger’s disease refractory to conventional treatment, a complete therapeutic response was achieved in 80% of patients treated with bosentan; 12% achieved a partial response.[61]
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