Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers

A randomized, double-blind, placebo-controlled, parallel, exploratory phase 2a study to evaluate safety and biologic efficacy on wound healing of ILP100-Topical in subjects with diabetic foot ulcers during 26 weeks with a 5-year long-term follow-up period. A total of 30 subjects will be randomized to low dose of ILP100-Topical (ILP100Lo), high dose of ILP100-Topical (ILP100Hi) or Placebo according to a 1:1:1 randomization schedule.The study will consist of a 3-weeks Screening and Run-in Phase, followed by a 5-week Treatment Phase starting from Baseline and an Assessment Phase from Week 5 to Week 26. Thereafter, the subjects will be followed yearly during 5 years in a Long-Term Safety Follow-up Phase.

Inclusion Criteria:Signed written informed consentMales and females aged ≥18 yearsDiagnosis of diabetes mellitus type 1 or 2HbA1c ≤ 86 mmol/mol (≤ 10%) at ScreeningSubjects with at least one first time or recurrent full thickness ulcer (below the ankle) that fulfils all of the following criteria at Screening and at the time of Baseline:A non-interdigital woundAccessible for administration of IMP, wound study assessments and proceduresPersistence of the wound for at least 6 weeks at BaselineMinimum full skin ulcer without undermining, with no exposed muscle, tendon or boneA wound area of 1.0 - 5.0 cm^2 after sharp or mechanical debridement at ScreeningDuring the 2-weeks between start of Run-in Phase and Baseline the wound size must not decrease by more than 30% or increase by more than 25%, which correspond to wound areas of 0.7 - 6.3 cm^2Toe pressure ≥30 mm HgExpected to comply with the study proceduresExclusion Criteria:Has any clinically infected diabetic foot ulcer at Screening and Baseline, confirmed by bacterial wound culture, or ongoing antibiotic treatmentThe index wound determined as heavily exuding defined as requiring more than 1 dressing change per day or requiring use of super absorbent dressingWound duration longer than 1 yearActive Charcot deformity of the study footEstimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2Hemoglobin concentration <100 g/L at BaselinePlanned or ongoing treatment with corticosteroids to an equivalent dose of prednisolone >10 mg per day or other immunosuppressive therapy, or such treatment within 4 weeks prior to BaselineHas any major surgery or hospitalization planned up to Week 26Has changed a treatment for diabetes during the last 3 weeks before Baseline. Dose change is allowedOngoing treatment with dipeptidyl peptidase 4 (DPP-4) inhibitorsRevascularization procedure in the index wound leg planned or undertaken within 8 weeks before Screening, or under investigationCurrent smokersParticipation in other clinical studies or having received any investigational treatment within 1 month or at the earliest five times the half-life prior to ScreeningHas any disease conditions, including ulcerative dermatological disorders and vasculitis, or comorbidities which is expected to prevent the subject from participating in the study or confounding the evaluation of the safety profile and effect on wound healing of ILP100Pregnant or lactating womanMale subjects not willing to use a condom and refrain from donating spermFemale subjects of childbearing potential unless they use a contraceptive method with a failure rate of < 1% to prevent pregnancy