Bee VenomulcerNCT06374563
Tackling Pressure Ulcer Via Bee Venom Phonophoresis
A study testing group 1 received topical Bee venom gel and Group 2: Phonophoresis of Bee Venom gel in people with Bee Venom and Pressure Ulcers, run by Badr University at 1 site in Egypt.
Trial summary
This study aimed to investigate the efficiency of topical Bee Venom gel versus phonophoresis of Bee Venom gel to accelerate healing of chronic pressure ulcer Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Bee Venom, Pressure Ulcers, Phonophoresis
- What is being tested?
- group 1 received topical Bee venom gel and Group 2: Phonophoresis of Bee Venom gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Nov 2022to 1 Mar 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with stage II and III chronic neuropathic ulcers.
Who cannot join
- Patients with chronic cardiac,
- Patients with renal, and
- Patients with hepatic diseases and
- Diabetic patients. Additionally,
- Patients with immunosuppressive diseases,
- Patients with HIV, and
- Anemia Patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tackling Chronic Pressure Ulcer Via Bee Venom Phonophoresis
This study aimed to investigate the efficiency of topical Bee Venom gel versus phonophoresis of Bee Venom gel to accelerate healing of chronic pressure ulcer
Read the detailed description
In this study, the Bee Venom gel was prepared in a gel formula. Patients with chronic pressure ulcers were enrolled randomly into two different groups. Group 1 received a topical application of Bee Venom gel, 3 times per weeks. While group 2 received phonophoresis of Bee Venom gel using low frequency ultrasound, 3 times per week. The treatment lasted for 8 consecutive weeks. The Image J Software is used to measure the wound surface area before and after treatment.
- Conditions
- Bee Venom, Pressure Ulcers, Phonophoresis
- Being tested
- group 1 received topical Bee venom gel, Group 2: Phonophoresis of Bee Venom gel
- Keywords
- phonophoresis, bee venom
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group 1 received topical Bee venom gelOther
Group 1 received a topical application of Bee Venom gel, 3 times per weeks. The wound dressing changed day after day and was cleaned every time with normal saline.
Group 2: Phonophoresis of Bee Venom gelOther
group 2 received phonophoresis of Bee Venom gel using low frequency ultrasound, 3 times per weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 received topical application of Bee Venom gel, 3 times per week Receives: Other: group 1 received topical Bee venom gel |
| group 2 | Experimental | Group 1 received phonophoresis of Bee Venom gel using low intensity ultrasound, 3 times per week Receives: Other: Group 2: Phonophoresis of Bee Venom gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound surface area wound surface area
ImageJ Software was used to measure the wound size
Measured: Before starting treatment and after 8 weeks of treatment
wound volume
wound volume was measured through the volumetric measurement method using a syringe filled with saline
Measured: Before starting treatment and after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start9 Nov 2022
- Primary completion1 Jan 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bee VenomStudies 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
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Alaa, Badr University
- Investigators
- Ashraf Hassan, professor, Study director, Badr University in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374563
- Sponsor's protocol ID
- BUC-IACUC-221109-6
- Acronym
- ulcer
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 18 Apr 2024
- 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 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tackling Chronic Pressure Ulcer Via Bee Venom Phonophoresis
- ClinicalTrials.gov ID
- NCT06374563
- Acronym / sponsor ID
- ulcer / BUC-IACUC-221109-6
- Conditions
- Bee Venom, Pressure Ulcers, Phonophoresis
- Keywords
- phonophoresis, bee venom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 18 Apr 2024 (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.
This study aimed to investigate the efficiency of topical Bee Venom gel versus phonophoresis of Bee Venom gel to accelerate healing of chronic pressure ulcer
Detailed description
In this study, the Bee Venom gel was prepared in a gel formula. Patients with chronic pressure ulcers were enrolled randomly into two different groups. Group 1 received a topical application of Bee Venom gel, 3 times per weeks. While group 2 received phonophoresis of Bee Venom gel using low frequency ultrasound, 3 times per week. The treatment lasted for 8 consecutive weeks. The Image J Software is used to measure the wound surface area before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: group 1 received topical Bee venom gelGroup 1 received topical application of Bee Venom gel, 3 times per week |
| group 2 | Experimental | Other: Group 2: Phonophoresis of Bee Venom gelGroup 1 received phonophoresis of Bee Venom gel using low intensity ultrasound, 3 times per week |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with stage II and III chronic neuropathic ulcers.
Key exclusion criteria (7 listed)
- Patients with chronic cardiac,
- Patients with renal, and
- Patients with hepatic diseases and
- Diabetic patients. Additionally,
- Patients with immunosuppressive diseases,
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 |
|---|---|---|
| group 1 received topical Bee venom gelGroup 1 received a topical application of Bee Venom gel, 3 times per weeks. The wound dressing changed day after day and was cleaned every time with normal saline. | Other | Group 1 |
| Group 2: Phonophoresis of Bee Venom gelgroup 2 received phonophoresis of Bee Venom gel using low frequency ultrasound, 3 times per weeks | Other | group 2 |
Primary outcome
wound surface area wound surface area
Time frame: Before starting treatment and after 8 weeks of treatment
ImageJ Software was used to measure the wound size
wound volume
Time frame: Before starting treatment and after 8 weeks of treatment
wound volume was measured through the volumetric measurement method using a syringe filled with saline
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 18 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Bee Venom
RecruitingObservational study
Predominant Sensitizations to Single Bee Venom Allergens as a Risk Factor for Therapy Failure
Bee Venom Allergy
Not yet recruiting
Efficacy of Bee Venom Phonophoresis in Treating Chronic Sinusitis:
Chronic Sinusitis, Acute Sinusitis
Not yet recruiting
Phonophoresis With Bee Venom: Evaluating Its Efficacy in Managing Pain and Enhancing Mobility in Knee Osteoarthritis Patients
Knee Osteoarthritis, Osteoarthritis
Not yet recruiting
Virtual-reality Induced Immune Modulation in Allergic Patients
Hymenoptera Venom Allergy
Not yet recruitingPhase 1/2
Effect of Bee Venom on Chronic Kidney Disease-Mineral Bone Disorders in Hemodialysis Patients: a Randomized Controlled Trial
Chronic Kidney Disease, Bee Venom
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.
Ashraf Hassan, professor study director
Badr University in Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group 1 received topical Bee venom gel and Group 2: Phonophoresis of Bee Venom gel in people with Bee Venom and Pressure Ulcers, run by Badr University at 1 site in Egypt.
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 7 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 18 Apr 2024. 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 Egypt. 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?
wound surface area wound surface area (time frame: Before starting treatment and after 8 weeks of treatment). The study lists 2 primary outcomes in all. 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 18 Apr 2024.