Table 1 Key inclusion and exclusion criteria

 • Aged ≥ 18 years with a diagnosis of PDPN confirmed by a score ≥ 3 on the MNSI

 • HbA1c ≤ 9% (74.9 mmol/mol) at 3–6 months prior to screening and at screening

• Stable glycaemic control for ≥ 6 months prior to screening visit

• Average daily pain score over the last 24 h ≥ 4 (question 5 of BPI-DN) at the screening and the baseline visit

 • Primary pain associated with PDPN in the ankles or above

 • Significant pain (moderate or above) due to an aetiology other than PDPN

 • Any amputation of lower extremity

 • Clinically significant cardiovascular disease within 6 months prior to screening visit

 • Any active signs of skin inflammation around onychomycosis sites such as tenderness, redness, swelling or drainage

 • Body mass index ≥ 40 kg/m²

 • Hypersensitivity to capsaicin any capsaicin 8% patch excipients, EMLA ingredients, or adhesives

 • Use of oral or transdermal opioids within 7 days preceding patch application at baseline

• Pain that could not be clearly differentiated from, or conditions that might have interfered with, the assessment of PDPN, e.g., claudication, fasciitis tendinitis and arthritis

• Current or previous foot ulcer

• Severe renal disease as defined by a creatinine clearance < 30 mL/min

• Significant peripheral vascular disease^a

• Impaired glucose tolerance only – without diabetes mellitus

• Previous treatment with capsaicin 8% patch

• Use of any topical pain medication on the painful areas within 7 days preceding patch application at baseline