Phase III clinical trial: Dermofural®. Mild infection in diabetic foot ulcer

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.

Acronym of Public Title:

Dermofural® - DFU

Scientific title:

Phase III clinical trial in two stages, placebo-controlled, randomized, double-blind for the evaluation of the efficacy and safety of Dermofural® 0.15% ointment as an antibacterial in adult patients with mild infection in diabetic foot ulcers.

Acronym of Scientific Title:

EC III: Dermofural® - DFU

Secondary indentifying numbers:

CBQ/DFU/PD/2200

Issuing authority of the secondary identifying numbers:

Chemical Bioactive Center

Source(s) of monetary or material support:

Chemical Bioactive Center. Provincial Directorate of Health of Villa Clara.

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)

Reference number:

In process

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

Affiliation:

"Arnaldo Milián Castro" University Clinical Surgical Provincial Hospital

Postal address:

Avenida Hospital Nuevo e/ Circunvalación y Doble Vía

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:

Villa Clara, Policlínico Santa Clara, Dra. María Luisa González del Sol (Specialist of first degree in MGI)

Villa Clara, Policlínico XX Aniversario, Dra. Maritza Artiles Morales (Specialist of first degree in MGI)

Villa Clara, Policlínico Marta Abreu, Dra. Haydee López García (Specialist of first degree in MGI)

Villa Clara, Policlínico Chiqui Gómez, Dra. Miriam Fernández Castañeda (Specialist of first degree in MGI)

Villa Clara, Policlínico José Ramón León Acosta, Dra. Vilma Ferrer Suárez (Specialist of first degree in MGI)

Villa Clara, Policlínico Capitán Roberto Fleites, Dra. María Cecilia García Granela (Specialist of first degree in MGI)

Villa Clara, Policlínico Juan B Contreras, Dra. Dayrelis Quintero Quintero (Specialist of first degree in MGI)

Villa Clara, Policlínico Manuel Piti Fajardo, Dra. Nora Clavelo González (Specialist of first degree in MGI)

Villa Clara, 50 Aniversario, Dra. Anabel Enjamio Gallardo (Specialist of first degree in MGI)

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

07/06/2023

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 ulcer with mild infection

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):

Group 1 (study) Dermofural®, a daily application of the ointment, for 7 days, topical. First, the lesion will be cleaned with physiological saline or distilled water at room temperature. After drying, the product will be applied and a bandage will be placed. Group 2 (control) Placebo, a daily application of the ointment, for 7 days, topical. First, the lesion will be cleaned with physiological saline or distilled water at room temperature. After drying, the placebo will be applied and a bandage will be placed.

Intervention code:

Anti-Bacterial Agents

Anti-Infective Agents

Ointments

Placebos

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 (will be evaluated taking into account the severity of the infection according to the Criteria of the American Society of Infectious Diseases -IDSA- in the categories of: non-infected, mild, moderate and severe. A satisfactory clinical response will be considered when the lesion is in the non-infected category, that is, it does not present any signs or clinical symptoms of infection such as inflammation, induration, sensitivity, edema, redness, erythema, pain, local heat and purulent discharge). Measurement time: before starting treatment with Dermofural®/placebo and 48 hours after finishing it. Microbiological response (The presence or absence of bacterial growth in the samples taken from closed abscesses or secretions in the diabetic foot ulcer will be determined. Microbiological culture and antibiogram will be performed). Measurement time: before starting treatment with Dermofural®/placebo and 48 hours after finishing it. Global response (combination of clinical and microbiological response). It will be evaluated in the categories "Satisfactory" and "Unsatisfactory" where: - Satisfactory: when 48 hours after the last application of the assigned treatment, the clinical response of the lesion is in the non-infected category (no presence of any clinical signs and symptoms: inflammation, induration, tenderness, edema , redness, erythema, pain, local heat, hyperesthesia and purulent discharge) and present microbiological response (absence of bacterial growth in the DFU or healed ulcer). - Unsatisfactory: when 48 hours after the last application of the assigned treatment, the clinical response of the lesion is in the mild, moderate or severe categories and there is no microbiological response (there is bacterial growth in the DFU) or presents satisfactory clinical response (absence of clinical signs and symptoms) without microbiological response (there is bacterial growth).

Key secondary outcomes:

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: before starting treatment with Dermofural®/placebo and after finishing it. (Glucose mmol/L). Measuring time: daily, for 7 days (or Glycosylated hemoglobin %). Measuring time: before starting treatment with Dermofural®/placebo.

Selection criterias

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

Gender:

Male/Female

Minimum age:

19 year

Maximum age:

None

Inclusion criteria:

1. Patients with a microbiological and clinical diagnosis of mild DFU, newly diagnosed or previously treated, with a time elapsed since the last indicated treatment ≥ 4 weeks. 2. Grade 1 DFU according to Wagner's classification. 3. Neuropathic DFU. 4. Time elapsed since the last treatment indicated for DFU ≥ 4 weeks. 5. Patients ≥ 19 years old. 6. Patients who express their willingness in writing by signing the informed consent to participate in the research.

Exclusion criteria:

1. Pregnancy, puerperium or lactation. 2. History of allergy or hypersensitivity to Dermofural® /placebo or to any of its components. 3. Patients in whom the presence of bacterial infection is not confirmed in the initial microbiological culture of the lesion. 4. Chronic decompensated diseases including, but not limited to: diabetes mellitus, venous insufficiency, arterial hypertension, bronchial asthma, interstitial fibrosis, chronic renal failure, ischemic heart disease, symptomatic congestive heart failure, aortic stenosis, endocarditis, unstable angina pectoris , cardiac arrhythmia. 5. Patients who are being treated with immunotherapy or other cancer treatment or who have received it in the last three months prior to this study. 6. Autoimmune diseases. 7. History of psychiatric illnesses or mental incapacity that prevents you from expressing your willingness to participate in the study or makes your evaluation and treatment difficult. 8. Patient who has recently participated (1 month) or who is participating in another clinical trial at the time of selection. 9. Patients with active systemic or local infections that require the use of other antibacterial agents. 10. Patient with at least one DFU with moderate or severe infection. 11. Patients who have received systemic antibacterial treatment in the 72 hours prior to screening.

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:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

Stage 1: 60, Stage 2: NA

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. Master in Drug research and development.

Affiliation:

Chemical Bioactive Center

Postal Address:

Carretera a Camajuani, Km 5 1/2.

City:

Santa Clara, Villa Clara.

Country:

Cuba

Zip Code:

54830

Telephone:

+53-42281192 +53-42281473

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:

Cecilio

Last Name:

González Benavides

Specialty:

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

Affiliation:

"Arnaldo Milián Castro" University Clinical Surgical Provincial Hospital

Postal Address:

Nuevo Hospital e/ Circunvalacion y Doble Via

City:

Santa Clara, Villa Clara.

Country:

Cuba

Zip Code:

50100

Telephone:

+53-42270380

Email :

ceciliogonzalez@infomed.sld.cu [1]

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

"Arnaldo Milian Castro" University Clinical-Surgical Provincial Hospital (HAMC)

Budgeted Unit Municipal Health Directorate of Santa Clara

Status of evaluation:

In Evaluation

Status of evaluation date of Ethic Committee:

20/07/2022

Postal address of Ethic Committee :

Avenida Hospital Nuevo e/ Circunvalación y Doble Vía, Santa Clara, Villa Clara.

Buenviaje e/ Maceo y Unión, Santa Clara, Villa Clara

Telephone:

+53-42270033

+53-42205483

Email:

danielart@infomed.sld.cu

maritzaba@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

Study completion date:

15/01/2025

Date of available results:

17/12/2025

Date of first publication:

15/04/2025

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:

RPCEC00000423

Date of Registration in Primary Registry:

24/04/2023

Record Verification Date:

2023/04/24

Next update date:

2024/04/24

Link to the spanish version:

Click here [3]