Early Outpatient bFGF-Based Wound Care for Foot Lesions in Haemodialysis Patients: A Real-World Stepwise Limb-Salvage Strategy From Japan.

Haemodialysis patients face a markedly elevated risk of foot lesions because of coexisting diabetes mellitus (DM), peripheral arterial disease (PAD) and uremia-related impairment of wound healing. Structured outpatient strategies and the optimal place of basic fibroblast growth factor (bFGF) within a stepwise algorithm remain poorly defined. To report complete healing and its durability in haemodialysis patients treated with bFGF for foot lesions, and to propose a stepwise limb-salvage algorithm with prespecified escalation criteria in which bFGF precedes dehydrated human amnion/chorion membrane (dHACM) or surgery. Retrospective observational case series of 20 haemodialysis patients receiving bFGF (trafermin; Fiblast Spray) for foot lesions across three outpatient wound-care programmes. Wound status was documented by area, depth, tissue exposure and WIfI classification; perfusion was assessed in every patient by toe-brachial and ankle-brachial indices, duplex ultrasonography and angiography, independently of any pre-existing recorded diagnosis. Complete healing was defined a priori as 100% re-epithelialization confirmed on two consecutive visits at least 2 weeks apart. Tier entry criteria and escalation triggers were prespecified, using a wound-area reduction below 50% at 4 weeks as the principal threshold. The broader haemodialysis population (n = 212) served as contextual comparator. Mean age was 75.0 ± 7.3 years (range, 59-92); there were six men and 14 women. DM was present in 15 patients (75.0%) and registry-recorded PAD in 8 (40.0%), against 56.6% and 17.9% in the broader population; objective testing identified hemodynamically significant PAD in 12 patients (60.0%), all of whom were revascularized. Mean baseline wound area was 5.5 ± 3.4 cm (2), and WIfI stages 1-4 comprised 5, 8, 6 and 1 patients. Twelve patients (60.0%) were managed with bFGF alone, five (25.0%) required dHACM and three (15.0%) required surgery. Complete healing was achieved in 18 of 20 patients (90.0%) at a mean of 8.9 ± 4.4 weeks, with no amputation of any level. Over a median follow-up of 13.0 months (range, 6-28), recurrence at the same site occurred in two patients (10.0%); amputation-free survival at 12 months was 100% and overall survival 95%. The bFGF-treated cohort carried a disproportionate burden of DM and PAD, supporting targeted early biologic intervention in this highest-risk subgroup. Within a stepwise algorithm combining objective perfusion assessment with prespecified escalation criteria, 90% of wounds healed completely without amputation, providing a practical limb-salvage framework for this vulnerable population.