Dermofural-diabetic foot ulcers

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Effect and safety of Dermofural® 0.15% ointment in the treatment of bacterial infection in patients with mild diabetic foot ulcers

Secondary indentifying numbers:

CBQ/DFU/PD/1500

Issuing authority of the secondary identifying numbers:

Chemical Bioactive Center

Source(s) of monetary or material support:

Chemical Bioactive Center "Arnaldo Milian Castro" University Hospital

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

20/09/2016

Reference number:

1213/05.001.16 MA

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Cecilio

Last name:

González Benavides

Medical Specialty :

Specialist of first degree in MGI Specialist of second degree in Angiology and Vascular Surgery

Affiliation:

"Arnaldo Milian Castro" University Hospital

Postal address:

Nuevo Hospital e/ Circunvalacion y Doble Via

City:

Santa Clara, Villa Clara

Country:

Cuba

Zip Code:

50100

Telephone:

+53-42270380

Email address:

ceciliogonzalez@infomed.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

"Arnaldo Milian Castro" University Hospital, 27/01/2016

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

16/01/2017

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Diabetic foot ulcers

Health condition(s) code:

Diabetic Foot

Foot Ulcer

Diabetic Angiopathies

Diabetic Neuropathies

Diabetes Mellitus

Diabetes Complications

Leg Ulcer

Endocrine System Diseases

Skin Ulcer

Vascular Diseases

Cardiovascular Diseases

Intervention(s):

Dermofural® 0.15% ointment, once daily for 7 days by topical route. First cleaning the lesion will be performed with saline solution. Subsequent to drying, apply topical antimicrobial and placing bandage.

Intervention code:

Anti-Bacterial Agents

Anti-Infective Agents

Intervention keyword:

Dermofural, Topical antibacterial

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Clinical response (assessing the severity of infection according to the Infectious Diseases Society of America -IDSA- Criteria: uninfected, mild, moderate and severe). Measuring time: daily, during 7 days.

Key secondary outcomes:

1. Microbiological response (presence or absence of bacterial growth in the UPD). Measuring time: basal, end of treatment 2. Safety (identification of adverse events occurring during the application of the test product). Measuring time: daily, during 7 days.. Occurrence (yes/no), Description (EA presented is reported using an accurate medical terminology), Duration (date difference between the beginning and the end of the event), Intensity (mild, moderate or severe), Seriousness (serious/serious or not serious/not serious), Attitude toward the drug (unchanged or permanent discontinuation), Results (recovered, improved persists, worsens, death), Causation (likely/certain, probable, possible, unlikely, unrelated or not evaluable/unclassifiable), Local events (yes/no), Systemic events (yes/no). -Biochemical parameters (Hemoglobin g/L, total leukocyte count cells/L, neutrophils %, lymphocytes %, monocytes %, eosinophils %, basophils %, platelet count cells/L, erythro mm/h, creatinine mmol/L, TGO U/L, TGP U/L). Measuring time: baseline, end of treatment. (Glucose mmol/L). Measuring time: daily, for 7 days.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1. Patients who meet the established diagnostic criteria. 2. Patients older than 18 years. 3. Patients express voluntary by signing the informed consent to participate in research and completing the set exams.

Exclusion criteria:

1. Pregnancy, postpartum or breastfeeding. 2. History of allergy or hypersensitivity to Dermofural or any of its components. 3. Patients suffering or concern clinically determined by the physician either decompensated chronic illness. 4. Patients being treated with immunotherapy or other cancer treatment or who have received in the last three months prior to this study. 5. Patients with serious psychiatric disorders or mental disability that prevents him expressing their willingness to participate in the study or evaluation difficult. 6. Patients who are or have been recently involved (1 month) in another study. 7. Patients with other active infections requiring the use of antibacterial agents during the study. 8. Patients who have received systemic antibacterial therapy in the 72 hours before the start of the study. 9. Patients with more than one diabetic foot ulcer.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Yenni

Last Name:

González Lugo

Specialty:

Bachelor degree in Pharmaceutical Sciences

Affiliation:

Chemical Bioactive Center

Postal Address:

Carretera a Camajuani, Km 5 1/2.

City:

Santa Clara, Villa Clara

Country:

Cuba

Zip Code:

54830

Telephone:

+53-42-281192

Email :

yennig@uclv.edu.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Mirleida

Last Name:

Santos Marcelo

Specialty:

Bachelor degree in Pharmaceutical Sciences

Affiliation:

Chemical Bioactive Center

Postal Address:

Carretera a Camajuani, km 5 1/2

City:

Santa Clara, Villa Clara

Country:

Cuba

Zip Code:

54830

Telephone:

+53-42-281473

Email :

mirleida@uclv.edu.cu [3]

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000211

Date of Registration in Primary Registry:

11/03/2016

Record Verification Date:

2018/11/22

Next update date:

2019/11/22

Link to the spanish version:

Click here [4]