At 6 weeks, patients from this RCT (NT-DFU-AFF-01) with study DFUs that have not been reduced in area by at least 40% will be exited from the study and considered treatment failures. This group (Group 2C) will constitute the active population in this single arm study (NT-DFU-AFF-02). Study wounds will receive up to 12 weeks of continuing SOC and fHSAM.