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

ABSTRACT 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.