Tibial periosteal distraction for ischemic leg ulcers: animal and clinical cohort study.

Abstract

Ischemic leg ulcers (ILU) represent a severe manifestation of chronic limb-threatening ischemia (CLTI), characterized by high recurrence and amputation rates. This study evaluated the efficacy and safety of tibial periosteal distraction (TPD) for treating ILU through a combination of animal experiments and clinical trials. Nine Beagle dogs were randomly allocated into TPD group, tibial soft tissue distraction (TSD) group, and control group. Standardized 15-mm circular wounds were created on the foot, followed by periosteal distraction at a rate of 0.5 mm/day for 11 days. Parameters assessed included wound healing rates, serum VEGF levels, histopathological changes, and CT angiography/perfusion parameters. A multicenter retrospective cohort study was conducted from June 2019 to January 2024, enrolling 103 ILU patients treated with TPD compared with 127 patients receiving conventional treatment. Primary endpoints included ulcer healing rates at 3 and 6 months, amputation rates, and recurrence within 1 year. Secondary endpoints comprised complications and safety assessments. In animal study, the TPD group demonstrated accelerated wound healing compared to both control and TSD groups, with residual wound area of 2.08 ± 1.68% on day 16, versus 5.46 ± 1.98% in the control group and 12.49 ± 2.97% in the TSD group. Serum VEGF levels were markedly elevated in the TPD group from days 8 to 16 (peak: 27.25 ± 2.16 pg/ml vs. 17.90 ± 1.72 pg/ml in controls, P < 0.01). CT angiography revealed enhanced collateral circulation in the distraction region with increased tissue perfusion parameters (equivalent blood volume and arterial flow). In clinical study, the TPD group achieved superior healing rates compared to controls: 90.3% vs. 77.2% at 3 months (P = 0.008) and 94.2% vs. 85.8% at 6 months (P = 0.039). Major amputation rate was reduced in the TPD group (2.9% vs. 9.5%, P = 0.046), while minor amputation rates showed no significant difference (38.8% vs. 44.1%, P = 0.421). Recurrence within 1 year was markedly decreased (8.7% vs. 19.7%, P = 0.020). Complications included pin tract infection in 7 cases (6.8%) and pain intolerance requiring distraction rate adjustment in 9 cases (8.7%), all successfully managed with conservative treatment. TPD offers a promising therapeutic option for CLTI patients, particularly those unsuitable for vascular reconstruction. Further prospective randomized trials are warranted to establish standardized protocols and optimize treatment parameters.