Clinical trial NCT03649243: Propolis as Adjuvant in the Healing of Human Diabetic Foot Wounds
Official title: Propolis as Adjuvant in the Healing of Human Diabetic Foot Wounds Receiving Care in Diagnostic and Treatment Center From Regional Hospital of Talca
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Foot wounds
oxidative stress
inflammation
propolis
Lead sponsor: University of Talca
Sponsor class: OTHER
Collaborators: name: Hospital Regional de Talca
First posted: 2018-08-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population corresponds to patients undergoing treatment for diabetic foot in the regional hospital of Talca, are in personalized pharmacological treatment, nursing care for each of the diabetic foot ulcers and control at least 2 times a week for healing.

Brief summary: The general objective of the project is "To evaluate the effect of the administration of propolis extract as a coadjuvant in the treatment of diabetic foot ulcers in patients receiving cures in the Specialties Polyclinic of the Regional Hospital of Talca, Maule Region", which will be used Propolis produced in the area, (Laboratorios Rotterdam Ltda.) used in topical form.

It has been described that among the benefits produced by Propolis, is its anti-inflammatory, antioxidant effect and that the topical application of it is well tolerated, improving the healing of human diabetic foot ulcer.

Detailed description: They will be invited to enter the study, at no cost, to 72 patients seen in the Specialty Clinic of the Regional Hospital of Talca, who have a history of diabetic feet with ulcers and who are in treatment with cures and who meet the following criteria. inclusion:

* People with Diabetes Mellitus (DM), older than 18 years, type 1 or 2, with known evolution of their diabetes between 2 and 15 years.
* Carriers of diabetic foot ulcers
* Without other important diseases

Patients who present the following criteria will be excluded from the study:

* Propolis allergy
* Serious circulation problems
* Foot burns
* Psychological conditions, or distances that prevent regular attendance to all required cures.

According to the programmed, 72 people will be admitted to the study, of which half will receive Propolis application on their wound at the end of their usual healing, for a maximum period of 75 days; while the other half will maintain the usual cure without Propolis.

All participants must maintain the usual treatment of their illness, as well as the usual type and frequency of their cures and maintain their physical activity according to the medical indication during this period. After 75 days, those who did not receive Propolis will have the possibility to receive it in the same way for 75 days.

All patients in the study must have a recent basic evaluation of their Diabetes performed in their office or the Specialties Polyclinic of the Regional Hospital of Talca at the beginning (up to 30 days prior) and at the end of the treatment, consisting of glycemia and glycosylated hemoglobin.

Tissue samples will be taken from your wound to make measurements of inflammation, degree of healing, infectionand oxidative stress, at the beginning, week 3, 6 and at the end of the study (75 days). The sample at the end of the study will only be obtained if the wound is still open.

In addition, at the beginning and at the end a blood sample of 5cc will be taken to measure levels of inflammatory markers and oxidative stress in blood.

These samples will be taken in the same Specialty Clinic of the Regional Hospital of Talca, but they will be transferred to be processed in the Clinical Biochemistry Laboratory of the Faculty of Health Sciences and the School of Medicine of the University of Talca. . Samples will be stored frozen at -80 ° C, under a code to guarantee confidentiality, for a period of 2 years, after which they will be eliminated.

During the last care / healing that the nurse does to the patient, you will be asked to complete a survey with questions to collect personal opinions about the effect of topical propolis.

Benefits: It has been described that the topical application of Propolis can improve the healing of human diabetic foot ulcer.

Eligibility criteria: Inclusion Criteria:

* DM type 1 or 2 with complicated foot diabetics wounds.
* 18-80 years old

Exclusion Criteria:

* Propolis allergy
* Critical ischemia
* Severe infection
* Psycho-social conditions that avoid regular attendance at health aid.

Primary outcomes:
measure: allergenic to propolis analysis
timeFrame: through study completion, with an average of 8 months
Secondary outcomes:
measure: obtaining biopses
timeFrame: the first biopses was obtained at time zero of enrollment and every 4 weeks, until the wound close or at time 12 weeks (end point of the biopses obtaining)
Other outcomes:
Locations:
Study officials:
affiliation: University of Talca
name: elba Leiva, Mg
role: STUDY_DIRECTOR
References:
citation: Mujica V, Orrego R, Fuentealba R, Leiva E, Zuniga-Hernandez J. Propolis as an Adjuvant in the Healing of Human Diabetic Foot Wounds Receiving Care in the Diagnostic and Treatment Centre from the Regional Hospital of Talca. J Diabetes Res. 2019 Sep 12;2019:2507578. doi: 10.1155/2019/2507578. eCollection 2019.