patients with type 1 or type 2 diabetes with infected foot ulcers MedDRA version: 14.1 Level: PT Classification code 10021784 Term: Infected skin ulcer System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: G.68.y/EtOH
Pharmaceutical Form: Gel
INN or Proposed INN: Other chemotherapeutics
Current Sponsor code: RLP068 chloride (RLP068Cl)
Concentration unit: % percent
Concentration type: equal
Sponsors
MOLTENI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females of any race, aged 18 years or over. Females of childbearing potential must have a negative urine pregnancy test prior to commencing the study. 2. Diagnosis of type 1 or 2 diabetes. 3. A diabetic foot wound grade I or II and staging B or D, according to the TEXAS diabetic wound classification system. 4. Presence of infected foot ulcer of grade 2 (according to the PEDIS diabetic foot ulcer classification system), diagnosed via a clinic examination. 5. Presence of ulcer with an area from 2 to 15 cm2 and with a maximum diameter/length �¢���¤ 4.6 cm measured by the VISITRAK�¢���¢ system. 6. No concurrent illness indicating a life expectancy of less than 3 months. 7. Able to take oral medications. 8. Patients must provide their written informed consent to participate in the study. 9. Patients must be willing and able to comply with the protocol and study procedures. 10. Non-childbearing potential and childbearing potential female patients who agree to use an acceptable method of contraception for 60 days after the Treatment Visit (i.e., 60 days from the first and only application of the study drug) providing they are not pregnant or lactating. 11. Male patients must agree to use adequate methods of contraception for 30 days from the time of the Treatment Visit (i.e. 30 days from the first and only application of the study drug). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Female patients who are pregnant or breast-feeding. 2. Participation in any other clinical trial or currently receiving any other investigational product(s) within 30 days prior to study treatment (Visit 0 or Visit 1). 3. Patients that cannot take Augmentin at the dosage stated in the protocol and according to the current Summary of Product Characteristics (SPC). 4. Ankle brachial systolic blood pressure index (Winsor Index) < 0.5 in the infected limb. 5. Clinical diagnosis of peripheral vascular disease (PVD) with ischemic ulcer, requiring percutaneous or surgery revascularization. 6. Ulcer probe to bone positive. 7. Prior anamnestic diagnosis of methicillin-resistant Staphylococcus aureus (MSRA) infection. 8. Any surgery planned in the study period, including scheduled amputation at the infected site. 9. Use of any other photodynamic therapy agents (e.g. Foscan and Photofrin) in the 5 days before study treatment (Visit 0 or Visit 1). 10. Use of any antibiotics (local or systemic) in a continuative way for a period � 5 days prior to Treatment Visit (Visit 1). 11. Use of cortisone or other corticosteroids (local or systemic) in the 5 days before study treatment (Visit 0 or Visit 1). 12. Diagnosis of severe medical conditions such as severe heart failure or severe hepatic disease, according to the Investigator�s judgment. 13. Existence of any surgical or medical condition which, in the judgement of the Investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug product. 14. Diagnosis of current cancer. 15. History of any medical or psychiatric conditions that, according to the Investigator, may increase the risks associated with the study�s participation or investigational product(s) administration. 16. History of any clinically significant photosensitive skin disorder. 17. Anamnestic diagnosis of alcohol dependence or substance dependence. 18. Known hypersensitivity to the TegadermTM patch. 19. Diagnosis of Acanthosis nigricans.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a single, topical dose of G.68.Ã?Â?Ã?³/EtOH (0.1%, 0.3%, 0.5%) compared to placebo immediately after photoactivation with red light in patients with type 1 or type 2 diabetes with infected grade 2 foot ulcers, as measured by reduction in ulcer bacterial load.;Secondary Objective: To evaluate at Day 3, Day 8 and Day 15, the maintenance of efficacy, and the safety and tolerability of a single, topical dose of G.68.y/EtOH (0.1%, 0.3%, 0.5% w/w) after photoactivation with red light compared to placebo, in patients with type 1 or type 2 diabetes with infected grade 2 foot ulcers.;Primary end point(s): The primary efficacy endpoint is the reduction in the ulcer bacterial load between pre-treatment (baseline) and immediately after illumination on Day 1 (Visit 0 or Visit 1) as measured by an ulcer sample drawn with a flocked nylon swab.;Timepoint(s) of evaluation of this end point: Day 1: pre-treatment (baseline) and immediately after illumination | — |
Countries
Italy
Contacts
Public ContactMolteni
Molteni
Outcome results
None listed