LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers

Inclusion criteria

• People aged 18 years and over who have diabetes complicated by one or more ulcers on a foot or both feet below the level of the malleoli, excluding ulcers confined to the interdigital cleft.
• Those with more than one eligible ulcer will have one - usually the largest or more clinically significant - selected at screening as the index ulcer.
• Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will decrease by less than 50 % during a four week run-in period.
• The cross-sectional area of the index ulcer will be ≥50 and ≤1000 mm2 at the end of the 4 week run-in period.
• At randomisation, the index ulcer will be clinically non-infected according to IDSA criteria
• Either the ankle-brachial index (ABPI) in the affected limb will be between 0.50 and 1.40 or the dorsalis pedis pulse and/or tibialis posterior pulse will be palpable.
• HbA1c ≤108 mmol/mol at screening
• Participants will have the capacity to understand study procedures, and will be able to provide written informed consent.

Exclusion criteria

• Haemoglobin concentration <105 g/L or 6.5 mmol/L at screening.
• Presence of sickle-cell anaemia, haemophilia, thrombocytopenia (<100x109/L) or other clinically significant blood dyscrasia
• Known potential infectivity of blood products, including known HIV and hepatitis
• Dialysis or an estimated GFR (based on cystatine C or serum creatinine) <20 ml/min/1.73m2
• Increase in cross-sectional area of the index ulcer by ≥25% during the 4 week run-in period, or is either smaller than 50 mm2 or larger than 1000 mm2 at the end of that time.
• Clinical signs of infection of the index ulcer or reason to suspect that infection is present at randomisation.
• Revascularisation procedure in the affected limb planned, or undertaken within the preceding 4 weeks.
• Current treatment with cytotoxic drugs or with systemically administered glucocorticoids or other immunosuppressants.
• Treatment of foot ulcers with growth factors, stem cells or equivalent preparation within the preceding 8 weeks
• The need for continued use of negative pressure wound therapy
• Likely inability to comply with the need for weekly visits because of planned activity.
• Participation in another interventional clinical foot ulcer-healing trial within last the 4 weeks at the time of screening.
• Prior randomisation in this trial.
• Judgement by the investigator that the patient does not have the capacity to understand the study procedures or provide written informed consent.