Dermofural-diabetic foot ulcers

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000211
• Date of registration: 11/03/2016
• Prospective Registration: Yes
• Primary sponsor: Chemical Bioactive Center
• Public title: Dermofural-diabetic foot ulcers
• Scientific title: Effect and safety of Dermofural® 0.15% ointment in the treatment of bacterial infection in patients with mild diabetic foot ulcers
• Date of first enrolment: 16/01/2017
• Target sample size: 37
• Recruitment status: Complete
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000211-En
• Study type: Interventional
• Study design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment
• Phase: 2

Countries of recruitment

Cuba

Contacts

• Name: Mirleida Santos Marcelo
• Affiliation: Chemical Bioactive Center

• Name: Yenni González Lugo
• Affiliation: Chemical Bioactive Center

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Diabetic foot ulcers

Diabetic Neuropathies

Diabetic Angiopathies

Diabetes Complications

Skin Ulcer

Cardiovascular Diseases

Leg Ulcer

Endocrine System Diseases

Vascular Diseases

Diabetic Foot

Foot Ulcer

Intervention(s)

Anti-Bacterial Agents

Dermofural, Topical antibacterial

Anti-Infective Agents

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.

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.

Secondary Outcome(s)

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.

Secondary ID(s)

CBQ/DFU/PD/1500

Source(s) of Monetary Support

Chemical Bioactive Center "Arnaldo Milian Castro" University Hospital

Secondary Sponsor(s)

Not applicable