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P.273 Sharp debridement of digital ulcer in systemic sclerosis (shed SSc): a multicenter randomised control trial feasibility study

jsrd · 2026-06-05 · canonical JSON source

12 visible annotations · policy: published · automated confidence ≥ 75.00%

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Introduction Digital ulcers (DUs) affect approximately 50% of patients with systemic sclerosis (SSc), often presenting as painful, recurrent, and slow-healing lesions. Local wound care aims to promote healing and prevent complications such as infection and amputation. Sharp debridement has been proposed to enhance DU healing, but evidence supporting its efficacy remains limited. This study assessed the feasibility of a fully-powered randomised controlled trial (RCT) evaluating sharp debridement for DUs in SSc.Material and Methods An open-label feasibility RCT was conducted at Leeds Teaching Hospitals and Royal Free London NHS Trusts. Adults with SSc and active DUs were randomised (1:1) to receive either sharp debridement with topical anaesthesia plus standard wound care (intervention) or standard wound care alone (control). Follow-up continued for 24 weeks. Intended clinic visit frequency varied by clinical phase: approximately weekly during active debridement, then every 14–21 days in the intervention arm; and every 7–21 days per clinician judgement in the control arm.Primary feasibility outcomes included recruitment, retention, and adherence to allocation. Secondary clinical outcomes included time to healing, ulcer status, infection, pain, tolerability, physical function, quality of life (needs-based and health-related), and healthcare resource use. Data were summarised descriptively.Results Of 78 patients screened, 53 (67.9%) were eligible and 34 (64.2%) were randomised (18 intervention, 16 control; one control participant was subsequently excluded post-randomisation) ( table 1). Allocation adherence was 100%. At 24 weeks, 82.4% (28/34) of participants remained in the study and provided follow-up data. Data completeness ranged from 92.9% to 100% across most patient-reported outcomes.At week 12, ulcer healing was observed in 50% (9/18) of intervention participants versus 33.3% (5/15) in controls. By week 24, healing rates increased to 66.7%(12/18) and 60.0%(9/15), respectively. Pain scores decreased by almost 4 fold in the intervention arm (mean 6.7 to 1.8) compared to 2 fold in the control arm (mean 6.5 to 3.2). Clinical signs of infection were reported during at least one treatment visit for 4 participants in the intervention group and 5 in the control group. No adverse events were attributed to the intervention.Conclusions Recruitment rates, retention, and protocol adherence support the feasibility of a large-scale, multicentre RCT. Preliminary findings suggest potential benefits of sharp debridement in promoting ulcer healing and reducing ulcer pain. A fully-powered trial is warranted to determine clinical effectiveness.Abstract P.273 Table 1Baseline clinical data and demographics