Diabetic Foot Ulcer MedDRA version: 24.0 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer System Organ Class: 100000004858
Conditions
Interventions
Product Name: APO-2 for dilution to 12.5 U/ml
Product Code: APO-2
Pharmaceutical Form: Concentrate for cutaneous solution
Current Sponsor code: APOSEC
Concentration unit: U/ml unit(s)/millilitre
Conce
Sponsors
Aposcience AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is between 18 and 80 years of age 2. Patients with Type I or Type II diabetes with a glycosylated hemoglobin (HbA1c) of = 12%, obtained at enrollment or within 30 days prior to study enrollment 3. Patients who have a wound defined as diabetic foot ulcer present for = 4 weeks 4. Foot ulcer Wagner grade I– II or ARMSTRONG grade I-A (superficial, non-infected, non-ischemic wound not involving tendon, capsules, or bone) or II-A (non-infected, non-ischemic wound penetrating to tendon or capsule but not to the bone or joint) 5.Estimated foot ulcer surface area between = 0.8 cm2 and = 8 cm2 as measured at day of randomization assessed using the eKare imaging and measurement device 6. A patient with more than one diabetic foot ulcer may be included in the study but only one ulcer will be selected for the investigational treatment based on Investigator judgment as far as the ulcer meets the inclusion criteria (the largest ulcer fitting the inclusion criteria will be selected as index ulcer) 7. Wound area has not changed by more than 30 % between screening visit and randomization visit (at least 14 days) 8.Adequate arterial blood perfusion measured on the leg with treated wound (ABI [ankle brachial index] =0.5 [the lowest ABI measured value will be used as reference], or toe pressure > 40 mmHg, or tcPO2 > 40 mmHg) within the past 6 months including patients with mild to moderate peripheral arterial disease (Fontaine Stage I and II) 9. Patient must adhere to off-loading of the ulcer area (in mobile patients adherence to off-loading footwear during the study is mandatory) 10. Patient is able to give written informed consent prior to study start and to comply with the study requirements 11. Women of childbearing potential agree using adequate birth control methods during the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 66 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 66
Exclusion criteria
Exclusion criteria: 1. History of anaphylaxis, known hypersensitivity to sodium alginate, propylene glycol, methylene-blue or chicken-egg 2. Target ulcer is over a deformity (such as Charcot deformity) that interferes with off-loading based on investigator's opinion 3. Index wound duration of > 3 years without intermittent healing 4. Clinical evidence of ulcer bed infection or patients requiring intravenous (IV) antibiotics to treat the index wound infection at time of randomization 5. Current evidence of osteomyelitis, cellulitis, or other evidence of infection including pus drainage from the wound site, or documented history of osteomyelitis at the target wound location during the 8 weeks preceding the screening visit 6. Major uncontrolled medical disorder(s) such as severe uncontrolled leg edema, concurrent medication, or other issue that renders the patient unsuitable for participation in the study, including but not limited to: comorbid condition with an estimated life expectancy of = 12 months, hemoglobin A1c (Hba1c) > 12% at screening, patients on dialysis, patients with severe pulmonary (requiring home oxygen, uncontrolled COPD Gold III/ IV) or cardiovascular conditions (heart failure NYHA IV, uncontrolled hypertension systolic BP by repeated measurement > 180mmHg) 7. Raynaud disease or any other severe peripheral microvascular disease, current diagnosis of vasculitis 7a. Patients with PAD who - have not been assessed by vascular imaging as per standard of care or - have acute peripheral artery occlusion of the index extremity or - have PAD Fontaine Stage III and IV or - have PAD with planned revascularization during the upcoming 6 months or - had Angioplasty for re-perfusion in the lower extremity with target ulcer during 3 months preceding the screening visit 8. Dermatologic comorbid disease (e.g. pyoderma gangrenosum, vasculopathy or vasculitic ulcers), history of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger’s disease (thromboangiitis obliterans) 9. Patient currently treated for an active malignant disease or prior diagnosis of an active malignant disease who is disease free for less than 1 year. Treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy or gene therapy) within 3 months before the first administration of investigational product or at any time during the study. 10. Patient with history of malignancy within the wound; history of radiation therapy to the wound region 11. Patients who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days or during the study 12. Patients who received oral or parenteral corticosteroids, immunosuppressants, or cytotoxic agents within 30 days preceding the first study drug administration, or plan to use these medications during the study period 13. Patients who are pregnant or breastfeeding 14. Mental condition rendering the patient (or the patient’s legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study 15. Patients who are incarcerated, including prisoners or patients compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness 16. Therapy with another investigational agent within thirty days of screening, or during the study 17. Patients who are considered by the investigator to have a significant disease, which can impact the study; patients who are cons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine dose-response for clinical efficacy of APO-2 multiple dose administration in patients with diabetic foot ulcer at three different dose levels compared to placebo.;Secondary Objective: - To evaluate safety and tolerability of APO-2 at three different doses - To generate data on additional clinical endpoints ;Primary end point(s): Wound area reduction;Timepoint(s) of evaluation of this end point: Evaluation after 4 weeks treatment with APO-2 (Visit 14 = end of treatment visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. >50 % reduction in wound area 2. Wound size 3. Proportion of patients with complete wound closure (100% re-epithelialization of the wound surface with the absence of drainage) 4. Time to complete wound closure 5. Recurrence rate of the ulcer 6. Clinical assessment of peripheral neuropathy 7. Number of patients with local adverse events or serious adverse events (SAEs) with causal relationship to study medication 8. Evaluation of wound pain by visual analogue scale (VAS) 9. Evaluation of Quality of Life using Wound QoL questionnaire;Timepoint(s) of evaluation of this end point: Throughout the study (baseline until day 84) 1. after 4 weeks (binary outcome; Visit 14 = end of treatment visit) 2. at baseline, and 1, 2, 3, 4, 6, 8 and 12 weeks after first application of IMP (Investigational Medicinal Product) 3. during 12-week follow-up period 4. throughout the study (baseline until day 84) 5. during 12-week follow-up period 6. at baseline, 4, and 12 weeks after first application of IMP 7. throughout the study (baseline until day 84) 8. at baseline, at every treatment visit and 4, 6, 8 and 12 weeks after first application of IMP 9. at baseline, 4, and 12 weeks after first application of IMP | — |
Countries
Austria, Czech Republic, Germany
Contacts
Public ContactPriv.Doz.Dr. Ghazaleh Gouya-Lechner
Gouya Insights KG
Outcome results
None listed