Propolis as Adjuvant in the Healing of Human Diabetic Foot Wounds

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03649243
• Other study ID #: 2015-c03
• Status: Completed
• Start date: October 2015
• Est. completion date: March 2017

Study information

• Verified date: August 2018
• Source: University of Talca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Foot

Intervention

Drug:
• Propolis spray
Propolis was added at the site of injury, 3 puff for any wound in the foot of patients. All the patients decide voluntary if they want to receive the propolis spray treatment or only receive they normal wound healing care.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Talca	Hospital Regional de Talca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	allergenic to propolis analysis	All patients were analyzed for the probability of allergenic reaction. It was done on the dermal reaction compared to the reaction to a single dose of histamine.	through study completion, with an average of 8 months
Secondary	obtaining biopses	obtaining wound biopsies for histological and molecular analysis	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)