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

Inclusion Criteria:

• Signed written informed consent

• Males and females aged ≥18 years

• Diagnosis of diabetes mellitus type 1 or 2

• HbA1c ≤ 86 mmol/mol (≤ 10%) at Screening

• Subjects with at least one first time or recurrent full thickness ulcer (at or belowthe ankle) which fulfils all of the following criteria at Screening and at the timeof Baseline:

1. A non-interdigital wound

2. Accessible for administration of IMP, wound study assessments and procedures

3. Persistence of the wound for at least 6 weeks at Baseline

4. Assessed by the investigator to be of non-venous etiology.

5. Minimum full skin ulcer without undermining, with no exposed muscle, tendon orbone

6. A wound area of 1.0 - 5.0 cm^2 after sharp or mechanical debridement atScreening

7. During the 2-weeks between start of Run-in Phase and Baseline the wound sizemust not decrease by more than 30% or increase by more than 25%, whichcorrespond to wound areas of 0.7 - 6.3 cm^2, or at Screening expected by theInvestigator to have a high probability for wound size changes within thisrange during this period.

• Toe pressure ≥20 mm Hg

• Expected to comply with the study procedures

Exclusion Criteria:

• Infected index wound with clinical signs of inflammation at Screening or Baseline.

• The index wound determined as heavily exuding defined as requiring more than 1dressing change per day or requiring use of super absorbent dressing

• Wound duration longer than 2 years

• Active Charcot deformity of the study foot

• Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2

• Hemoglobin concentration <100 g/L at Baseline

• Planned or ongoing treatment with corticosteroids to an equivalent dose ofprednisolone >10 mg per day or other immunosuppressive therapy, or such treatmentwithin 4 weeks prior to Baseline

• Has any major surgery or hospitalization planned up to Week 26

• Has changed a treatment for diabetes during the last 3 weeks before Baseline. Dosechange is allowed

• Ongoing treatment with dipeptidyl peptidase 4 (DPP-4) inhibitors

• Revascularization procedure in the index wound leg planned or undertaken within 8weeks before Screening, or under investigation

• Current smokers

• Participation in other clinical studies or having received any investigationaltreatment within 1 month or at the earliest five times the half-life prior toScreening

• Has any disease conditions, including ulcerative dermatological disorders andvasculitis, or comorbidities which is expected to prevent the subject fromparticipating in the study or confounding the evaluation of the safety profile andeffect on wound healing of ILP100

• Pregnant or lactating woman

• Male subjects not willing to use a condom and refrain from donating sperm

• Female subjects of childbearing potential unless they use a contraceptive methodwith a failure rate of < 1% to prevent pregnancy