Propolis as Adjuvant in the Healing of Human Diabetic Foot Wounds

NCT03649243 | Completed DMC

• 1 other identifier: 2015-c03
• Study Type: observational
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Foot wounds; oxidative stress; inflammation; propolis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• obtaining biopses

  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)

Study Arms (2)

Propolis group

The patients receive propolis (3% in Propylene Glycol) in all the wound surface in each healing until cicatrisation or at least 8 weeks. (n=20)

Drug: Propolis spray

control group

the patients received the same care in the healing of their wounds, but no new component or propolis 3% was administered (n=8)

Interventions

Propolis spray DRUG

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.

Propolis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• DM type 1 or 2 with complicated foot diabetics wounds.
• years old

You may not qualify if:

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

Sponsors & Collaborators

• University of Talca: lead
• Hospital Regional de Talca: collaborator

Related Publications (1)

• 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.

  PMID: 31612147 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

biopsy of the ulcer site, after debridement

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Inflammation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• elba Leiva, Mg

  University of Talca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Laboratory, Unidad de Farmacología, Laboratorio de Investigaciones Médicas, Escuela de Medicina,

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: August 28, 2018
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2017
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share