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Propolis as Adjuvant in the Healing of Human Diabetic Foot Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649243
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Hospital Regional de Talca
Information provided by (Responsible Party):
Jessica Zuñiga-Hernandez, University of Talca

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.


Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Propolis spray

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 31 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Months
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
Actual Study Start Date : October 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.

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)



Primary Outcome Measures :
  1. allergenic to propolis analysis [ Time Frame: through study completion, with an average of 8 months ]
    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.


Secondary Outcome Measures :
  1. obtaining biopses [ Time Frame: 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) ]
    obtaining wound biopsies for histological and molecular analysis


Biospecimen Retention:   Samples With DNA
biopsy of the ulcer site, after debridement


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649243


Sponsors and Collaborators
University of Talca
Hospital Regional de Talca
Investigators
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Study Director: elba Leiva, Mg University of Talca

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jessica Zuñiga-Hernandez, Head Laboratory, Unidad de Farmacología, Laboratorio de Investigaciones Médicas, Escuela de Medicina,, University of Talca
ClinicalTrials.gov Identifier: NCT03649243    
Other Study ID Numbers: 2015-c03
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica Zuñiga-Hernandez, University of Talca:
Diabetes
Foot wounds
oxidative stress
inflammation
propolis
Additional relevant MeSH terms:
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Diabetic Foot
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies
Propolis
Anti-Infective Agents