A prospective cohort study of negative pressure wound therapy combined angioplasty for diabetic foot patients with critical limb ischemia

To evaluate the clinical efficacy and security of combined negative pressure wound therapy (NPWT) and percutaneous angioplasty (PTA) in the treatment of diabetic foot ulcers with critical limb ischemia (CLI). We enrolled 97 patients from 142 cases suffered from diabetic foot ulcers into this multi-center prospective cohort study. Patients who were assigned to NPWT-PTA (n=56) or NPWT (n=41) group based on standard off-leading therapy as needed, and were followed-up at 8 weeks and 20 weeks, their ankle-brachial pressure index (ABI), wound area, healing time and adverse events were monitored. A multivariate Cox proportional hazards regression analysis was used to determining the risk factors of wound healing. A greater proportion of wound healing in NPWT-PTA group was observed compared with NPWT group (61.5% vs 40.9%, P=0.004) at 20 weeks. The time of wound healing was earlier in NPWT-PTA group than NPWT group (48.3 +/- 32.8 days vs 77.1 +/- 27.1 days, P=0.009) at 20 weeks. ABI in NPWT-PTA group was higher than NPWT group at both 8 weeks (0.83 +/- 0.19 vs 0.46 +/- 0.15, P=0.000) and 20 weeks (0.72 +/- 0.17 vs 0.53 +/- 0.12, P=0.000). The decrease of ABI (HR=15.000, 95% CI=2.243-100.333, P=0.005) and increase of wound area (HR=0.926, 95% CI=0.866-0.990, P=0.025) were independent risk factors of wound healing. There was no significant difference in adverse events between the two groups. Combined NPWT with PTA therapy is effective and safe for diabetic foot ulcers with CLI by increasing the level of ABI, and results in a higher proportion of wounds closure.