Chronic Diabetic Foot Ulcers MedDRA version: 9.0 Level: LLT Classification code 10012664
Conditions
Interventions
Product Name: Dermal - Living Skin Replacement (Dermal - LSR)
Product Code: Not applicable
Pharmaceutical Form: Gel
Other descriptive name: Human dermal
Sponsors
ApoPharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects may be included in the study only if they meet ALL of the following criteria: 1. Subject or legal guardain/representative has signed a written informed consent form prior to the first study intervention. 2. Subject is =18 and 1.3, then a transcutaneous partial pressure of oxygen (TcPO2) of = 40 mmHg OR a toe pressure of = 50 mmHg must be obtained for subject to be eligible. 8. Subject, if female and of childbearing potential, has a negative serum pregnancy test prior to randomization and is neither breastfeeding nor intending to become pregnant during the course of the study and agrees to use effective contraception (oral or dermal contraceptives, approved implant or IUD) for the duration of the study, OR has undergone tubal ligation, hysterectomy or is post-menopausal (no menses for a period of 12 months). 9. Subject is able and willing to attend the scheduled visits and to comply with the study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 A
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study for ANY of the following reasons: 1. Known or suspected disease of the immune system currently under investigation, other than Diabetes Mellitus. 2. Active or untreated malignancy or active, uncontrolled connective tissue disease. 3. Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrolment. 4. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement. 5. Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb 3x the normal upper limit ? Chemistry of serum creatinine: > 2x the normal upper limit 8. Osteomyelitis, as confirmed by radionuclide bone scan. 9. Presence of an active Charcot as determined by the clinical examination (new local pain, evidence of swelling and warmth). 10. Use of any topical treatments, other than SOC, in or on the surface of the target ulcer at the time of enrolment. 11. Enrolment in any investigational clinical trial within 30 days of the screening visit. 12. Knwon or suspected hypersensitivity to any study product components. 13. Recent or current history of alcohol or drug abuse. 14. Any condition, which in the opinion of the Investigator, would interfere with the evaluation of the study product or poses a health risk to the subject. 15. All site personnel directly affiliated with this study and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of Dermal – LSR plus Standard of Care (SOC) for the treatment of chronic diabetic foot ulcers (DFUs) in comparison to treatment with SOC alone. To determine the safety of Dermal – LSR plus SOC for the treatment of chronic DFUs in comparison to treatment with SOC alone. ;Secondary Objective: Not applicable; Primary end point(s): Primary Efficacy Outcome: • Complete ulcer closure by week 12 Secondary Efficacy Outcomes: • Complete ulcer closure by week 20 • Time to achieve complete ulcer closure • Rate of ulcer healing • Relative ulcer area from baseline to week 20 • Recurrence of target ucler post closure to week 20 Safety Endpoints: Safety assessments will include the incidence of adverse events, adverse reactions, immediate reactions, local and systemic reactions, osteomyelitis, ulcer infection, amputations and serious adverse events/unanticipated adverse device effects. The potential for the development of an immune response to Dermal-LSR will be evaluated at the end of the study on retained serum samples collected at study entry and during the study period. | — |
Countries
United Kingdom
Outcome results
None listed