Pressure SoreNCT06936228
Evaluation of the Effect of Local Propolis Application on the Healing of Pressure Ulcers
A study testing Propolis spray in people with Pressure Sore, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to evaluate the effect of local propolis application in patients with pressure ulcers. A total of 62 patients were included in this randomized controlled experimental study, with 31 patients in the propolis group and 31 in the control group. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pressure Sore
- What is being tested?
- Propolis spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2022to 30 Nov 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient or their caregiver is able to communicate verbally, Hospitalized in palliative care or intensive care units for at least one week, Has a Stage 1, 2, or 3 pressure ulcer according to NPUAP (13), The wound has not been closed by a physician, Agrees to participate in the study, Expected to stay in the hospital for at least 21 days.
Who cannot join
- The patient or their caregiver is unable to communicate verbally, Has a Stage 4 or unstageable pressure ulcer according to NPUAP, The wound has been closed by a physician, Does not agree to participate in the study, Expected to stay in the hospital for less than 21 days.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bakanlığı Ordu Üniversitesi Eğitim ve Araştırma Hastanei
Ordu, 52100
About this study
Official title: Evaluation of the Effect of Local Propolis Application on the Healing of Pressure Sores
The study was conducted to evaluate the effect of local propolis application in patients with pressure ulcers. A total of 62 patients were included in this randomized controlled experimental study, with 31 patients in the propolis group and 31 in the control group. While the control group received the clinic's standard wound care treatment protocol, the propolis group was administered 30% pure propolis extract in addition to the standard wound care treatment protocol. For data collection, the following tools were used: the Introductory Characteristics Form, which includes patients' socio-demographic and medical information; the Propolis Application Follow-up Form; the Pressure Ulcer Healing Assessment Scale; pain assessment tools including the Visual Analog Scale (VAS) for conscious patients and the Face Pain Scale for unconscious patients; Katz's Index of Activities of Daily Living; and the Charlson Comorbidity Index (CCI).
- Conditions
- Pressure Sore
- Being tested
- Propolis spray
- Keywords
- Pressure ulcer, Propolis application, Apitherapy
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propolis sprayDietary supplement
The product obtained from 30% pure Anatolian propolis was applied once daily.
| Study group | Role | What they receive |
|---|---|---|
| 1 Propolis | Experimental | Propolis was applied in addition to standard wound treatment administered in the hospital for 21 days. Receives: Dietary Supplement: Propolis spray |
| 2 control | No intervention | The control group received standard wound care treatment administered in the hospital for 21 days, and the researcher did not intervene in any way. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pressure Ulcer Healing: PUSH (Pressure Ulcer Scale for Healing)
It was developed by the EPUAP (European Pressure Ulcer Advisory Panel) to monitor changes in pressure ulcers. It includes three subdimensions: tissue type, exudate amount, and pressure ulcer area. To calculate the pressure ulcer area, the length and width of the wound are multiplied, resulting in a value in cm². This value is then evaluated on a 10-point scale. The amount of exudate is scored as follows: none - 0 points, slight - 1 point, moderate - 2 points, and heavy - 3 points. The third subdimension, tissue type, is scored as follows: 4 points if there is necrotic tissue, 3 points if there is no necrotic tissue but eschar is present, 2 points if granulation tissue is present and the wound is clean, 1 point if epithelialization is observed, and 0 points if the wound is completely closed. The total score, ranging from 0 to 17, provides information about the condition of the ulcer. An increase in the score indicates greater severity of the ulcer.
Measured: 21-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start12 Apr 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure SoreStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Collaborators
- Karadeniz Technical University
- Responsible party
- Principal investigator, Cigdem Kuralay, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936228
- Sponsor's protocol ID
- Çiğdem Kuralay
- Other IDs
- Çiğdem KURALAY
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Local Propolis Application on the Healing of Pressure Sores
- ClinicalTrials.gov ID
- NCT06936228
- Acronym / sponsor ID
- Çiğdem Kuralay
- Conditions
- Pressure Sore
- Keywords
- Pressure ulcer, Propolis application, Apitherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Collaborators
- Karadeniz Technical University
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 20 Apr 2025 (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 study was conducted to evaluate the effect of local propolis application in patients with pressure ulcers. A total of 62 patients were included in this randomized controlled experimental study, with 31 patients in the propolis group and 31 in the control group. While the control group received the clinic's standard wound care treatment protocol, the propolis group was administered 30% pure propolis extract in addition to the standard wound care treatment protocol. For data collection, the following tools were used: the Introductory Characteristics Form, which includes patients' socio-demographic and medical information; the Propolis Application Follow-up Form; the Pressure Ulcer Healing Assessment Scale; pain assessment tools including the Visual Analog Scale (VAS) for conscious patients and the Face Pain Scale for unconscious patients; Katz's Index of Activities of Daily Living; and the Charlson Comorbidity Index (CCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Propolis | Experimental | Dietary Supplement: Propolis sprayPropolis was applied in addition to standard wound treatment administered in the hospital for 21 days. |
| 2 control | No intervention | –The control group received standard wound care treatment administered in the hospital for 21 days, and the researcher did not intervene in any way. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The patient or their caregiver is able to communicate verbally, Hospitalized in palliative care or intensive care units for at least one week, Has a Stage 1, 2, or 3 pressure ulcer according to NPUAP (13), The wound has not been closed by a physician, Agrees to participate in the study, Expected to stay in the hospital for at least 21 days.
Key exclusion criteria (1 listed)
- The patient or their caregiver is unable to communicate verbally, Has a Stage 4 or unstageable pressure ulcer according to NPUAP, The wound has been closed by a physician, Does not agree to participate in the study, Expected to stay in the hospital for less than 21 days.
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 sprayThe product obtained from 30% pure Anatolian propolis was applied once daily. | Dietary supplement | 1 Propolis |
Primary outcome
Assessment of Pressure Ulcer Healing: PUSH (Pressure Ulcer Scale for Healing)
Time frame: 21-day follow-up
It was developed by the EPUAP (European Pressure Ulcer Advisory Panel) to monitor changes in pressure ulcers. It includes three subdimensions: tissue type, exudate amount, and pressure ulcer area. To calculate the pressure ulcer area, the length and width of the wound are multiplied, resulting in a value in cm². This value is then evaluated on a 10-point scale. The amount of exudate is scored as follows: none - 0 points, slight - 1 point, moderate - 2 points, and heavy - 3 points. The third subdimension, tissue type, is scored as follows: 4 points if there is necrotic tissue, 3 points if there is no necrotic tissue but eschar is present, 2 points if granulation tissue is present and the wound is clean, 1 point if epithelialization is observed, and 0 points if the wound is completely closed. The total score, ranging from 0 to 17, provides information about the condition of the ulcer. An increase in the score indicates greater severity of the ulcer.
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 20 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propolis spray in people with Pressure Sore, run by Ordu University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Assessment of Pressure Ulcer Healing: PUSH (Pressure Ulcer Scale for Healing) (time frame: 21-day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2025.