Diabetes Mellitus, Type 2NCT03649243
Propolis as Adjuvant in the Healing of Human Diabetic Foot Wounds
An observational study of Diabetes Mellitus, Type 2, run by University of Talca.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Propolis spray
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Mar 2017
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- DM type 1 or 2 with complicated foot diabetics wounds.
- 18-80 years old
Who cannot join
- Propolis allergy
- Critical ischemia
- Severe infection
- Psycho-social conditions that avoid regular attendance at health aid.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Propolis spray
- Keywords
- Diabetes, Foot wounds, oxidative stress, inflammation, propolis
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propolis sprayDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, with an average of 8 months
Secondary outcomes (1)
obtaining biopses
obtaining wound biopsies for histological and molecular analysis
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Talca
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Regional de Talca
- Responsible party
- Principal investigator, Jessica Zuñiga-Hernandez, University of Talca
- Investigators
- elba Leiva, Mg, Study director, University of Talca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649243
- Sponsor's protocol ID
- 2015-c03
- Status last verified
- Aug 2018
- First submitted
- 12 Jun 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31612147
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03649243
- Acronym / sponsor ID
- 2015-c03
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Foot wounds, oxidative stress, inflammation, propolis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of TalcaUniversity, hospital or other
- Collaborators
- Hospital Regional de Talca
- Study start
- Oct 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propolis group | – | Drug: Propolis sprayThe patients receive propolis (3% in Propylene Glycol) in all the wound surface in each healing until cicatrisation or at least 8 weeks. (n=20) |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- DM type 1 or 2 with complicated foot diabetics wounds.
- 18-80 years old
Key exclusion criteria (4 listed)
- Propolis allergy
- Critical ischemia
- Severe infection
- Psycho-social conditions that avoid regular attendance at health aid.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propolis sprayPropolis 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. | Drug | Propolis group |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Derived from this study: PubMed 31612147Mujica 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
elba Leiva, Mg study director
University of Talca
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by University of Talca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
allergenic to propolis analysis (time frame: through study completion, with an average of 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03649243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.