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Aim: To assess efficacy and safety of regenerative therapy in healing of various open wounds. Method: Consecutive patients (n=276) with various open wounds (n=376) treated at 3 hospitals, were randomized to receive either regenerative therapy (Group 1, n=141) or saline dressing (Group 2 controls, n=135). Data collected prospectively included demographics, clinical, biochemical and wound characteristics. Surface area (SA) and healing index (HI) were calculated and compared at two-week intervals for 12 weeks, and secondary amputations were recorded at 12 months post-treatment. Results / Discussion: There was a significant increase in HI and reduction in SA starting two weeks after initiation of treatment with regenerative therapy. At 12 weeks, 66.3% (126/190) of wounds treated with regenerative therapy had complete healing as opposed to 22.6% (42/186) of those treated with saline (X²=70.98, p<0.0001). None of the 190 patients receiving regenerative therapy had a HI of <0.5 at 12 weeks as compared to 38.7% (72/186) of controls (X²=88.48, p<0.0001 -- Fisher's exact probability=0.0000). No adverse effects were encountered. At 12-weeks post-treatment, the secondary amputation rate in patients with diabetic foot ulcers was significantly reduced by regenerative therapy as compared to controls (4.34% [2/46] versus 18.6%% [8/43], respectively) (X²=3.21, p=0.0732 -- Fisher's exact probability=0.045). Conclusion: In addition to its safety, regenerative therapy promotes healing of open wounds with significant increase in HI and reduction of SA, starting two weeks post-treatment, with complete healing of approximately two-thirds of wounds by 12 weeks. At 12 months post-treatment, fewer secondary amputations were performed in patients treated with regenerative therapy than controls. [ABSTRACT FROM AUTHOR]