Diabetic foot ulcer (DFU) MedDRA version: 20.0 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer System Organ Class: 100000014568
Conditions
Sponsors
Prometic Biotherapeutics Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female aged 18-90 years (both inclusive) 2) Subject has signed informed consent 3) Diagnosed with type 1 or type 2 diabetes 4) Presence of a single ulcer on a foot that meets the following criteria: • Ulcer is below the malleolus and attributed to diabetes • Ulcer is in location that would allow multiple adjacent SC injections • Ulcer is of full skin thickness and may involve tendon or capsule, but does not probe to bone • Ulcer surface area is between 1-10 cm2 (both inclusive); NOTE: subject may have one or more DFUs on the other foot; if a subject has a single ulcer on both feet, and both ulcers are in locations that could receive SC injections, then the ulcer with the larger surface area should be chosen for study, provided it is 1-10 cm2 in size 5) Has received standard treatment of DFU for 4 weeks in investigator’s clinic before screening 6) Toe pressure >40 mm Hg 7) Female subjects of childbearing potential who are sexually active with a non-sterile male partner must have a negative urine pregnancy test at baseline and agree to use adequate birth control from screening throughout the study and for 4 weeks after the last IMP administration. If a male subject has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method throughout the study and for 4 weeks after the last IMP administration. 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1) History of hypersensitivity reaction to blood products, plasma-derived products, or aprotinin 2) Treatment with exogenous plasminogen (such as fresh frozen plasma), or a fibrinolytic agent (such as recombinant tissue plasminogen activator or streptokinase) during the 2 weeks before screening 3) Presence of osteomyelitis, gangrene, or cellulitis requiring intravenous (IV) antibiotic treatment. NOTE: Subjects using oral antibiotics for well-controlled cellulitis are eligible, provided the following criteria are also met: - Subject must have started the oral antibiotics prior to enrolment and be finishing a course of treatment - “Well-controlled” means no clinical sign of “active infection” at the time of screening and baseline exams - “Active infection” is defined as the presence of 2 or more of the following: frank purulence, local warmth, erythema, lymphangitis, oedema, pain, fever, and foul smell - Subjects receiving treatment for an infection with MRSA or other multi-resistant organism will be excluded regardless of the appearance of the wound 4) History of malignancy treated in past 3 years (except for basal cell skin cancer) 5) Creatinine >2x the upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) >3x ULN 6) HbA1c >90 mmol/mol 7) Treatment with cytostatic drugs, growth factors, immunosuppressive drugs, or anti-fibrinolytics (such as aminocaproic acid, tranexamic acid, or aprotinin) within 2 weeks before screening visit 8) Other significant medical condition that the investigator or sponsor determines could interfere with compliance or study assessments (such as: dementia, substance abuse, and end-stage renal/hepatic/cardiac disease) 9) If female: pregnant or lactating 10) Has participated in another investigational drug or medical device study for any medical condition during the 4 weeks prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety and tolerability of 5 mg and 10 mg Plasminogen (Human) 10 when injected subcutaneously (SC) in adult subjects with diabetic foot ulcer (DFU).;Secondary Objective: 1. To assess the feasibility of completing multiple 2-week treatment cycles of SC administered Plasminogen (Human) 10 (5 mg and 10 mg) in this subject population 2. To assess the initial efficacy of SC administered Plasminogen (Human) 10 (5 mg and 10 mg) on wound healing in this subject population 3. To assess the effects of SC administered Plasminogen (Human) 10 (5 mg and 10 mg) on subject and investigator-reported quality of life (QoL) outcomes in this subject population ;Primary end point(s): Number, type, severity, and causality of Adverse Events (AEs) by dose group, which will include administration-related reactions (eg, injection site erythema, edema, discomfort, or infection) and clinically significant abnormalities of physical examination, vital signs, and laboratory tests;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of injections that are technically feasible by dose group, defined as the ability to fully insert needle in vertical orientation 5 (±1) mm from ulcer margin and deliver entire dose of IMP without pushback of IMP into the syringe or spillage of IMP • Proportion of subjects with ulcer closure by dose group, defined as complete skin re-epithelialisation without dressing requirements, at any time during the study • Proportion of subjects with at least 50% ulcer surface area reduction at the end of the study compared with baseline by dose group • Proportion of subjects with increased ulcer surface area at the end of study compared with baseline by dose group • Proportion of subjects with recurrent ulcer post resolution at any time during the study after confirmed ulcer closure by dose group • Proportion of subjects with new/worsened cellulitis at any time during the study by dose group • Proportion of subjects with development of osteomyelitis at any time during the study by dose group • Proportion of subjects with need for amputation at any time during the study by dose group • Proportion of subjects with improvement or worsening of EQ-5D-5L (i.e. subject’s QoL) at the end of study compared with baseline by dose group • Proportion of subjects with improvement or worsening of clinical global impression (CGI) at the end of study compared with baseline by dose group ;Timepoint(s) of evaluation of this end point: Secondary endpoints 1, 3, 4, 9, and 10: Visit (9) Week 12 Secondary endpoints 2, 5, 6, 7, and 8: Visit (3 to 9) All study visits following Baseline visit | — |
Countries
Sweden
Contacts
Public ContactRegulatory Affairs
Prometic Biotherapeutics Ltd
Outcome results
None listed