Ulcer, LegNCT05285930
Effect of Bee Venom Phonophoresis on Healing of Chronic Lower Limb Ulcers
A study testing Bee venom phonophoresis and low intensity ultrasound in people with Ulcer, Leg, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: to determine the impact of bee venom phonophoresis in accelerating ulcers healing. BACKGROUND: Bee venom (BV) phonophoresis has been suggested as a noninvasive treatment for a number of inflammatory conditions and in healing of ulcers. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Ulcer, Leg
- What is being tested?
- Bee venom phonophoresis and low intensity ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 25 Feb 2022
- 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
- Eligible patients ranged in age from 40 to 60 years.
- They had not undertaken another physical therapy modality for ulcer healing
- non-smokers
- under their own prescribed medications, and controlled diet therapy as described by their physicians.
- All patients in the diabetic foot ulcer group (group B) were non-insulin dependent and had controlled blood glucose levels.
Who cannot join
- Patients with life-threatening disorders such as renal failure, myocardial infarction.
- any systemic diseases that may interfere with the study's objectives were excluded.
- patients with skin disease.
- any disease that can lead to ulcer rather than diabetes for the diabetic foot ulcer group only, as varicose veins, trauma, peripheral vascular diseases, and/or active malignancy.
- Ulcer with surface area of less than 2 cm2 or more than 8 cm2 would be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
PURPOSE: to determine the impact of bee venom phonophoresis in accelerating ulcers healing.
BACKGROUND: Bee venom (BV) phonophoresis has been suggested as a noninvasive treatment for a number of inflammatory conditions and in healing of ulcers.
Read more
Ulceration due to vascular causes is often multifactorial and can be caused by both arterial and venous disease. Hypertension and atherosclerosis of the peripheral vessels lead to arterial disease associated with ischemic ulcers. Chronic venous insufficiency and the resulting venous hypertension cause venous ulcers.
There are lack in knowledge and information in published studies about the efficacy of bee venom phonophoresis as physical therapy modality in accelerating ulcers healing.
So, this study will be designed to provide a guideline about the efficacy of of bee venom phonophoresis in accelerating ulcers healing.
HYPOTHESES:
It will be hypothesized that:
It was hypothesized that Bee venom phonophoresis has no or limited effect in accelerating ulcers healing.
RESEARCH QUESTION: Does Bee venom phonophoresis an effect in accelerating ulcers healing?
Read the detailed description
- A verbal explanation about the importance of this research procedure, main aims and conceptual approaches were explained to every participant. • Every participant was given his written informed consent for bee venom phonophoresis treatment • The procedures of this study were divided into two main parts: part one (measurement procedures) and part two (treatment procedures).
Bee venom allergy test: The participants had been tested for BV allergy; diluted BV, 0.05 ml, in normal saline (1 mg/ml) was injected intra-dermally into the forearm. If the tested lesion resulted in a wheal with a diameter of less than 10 mm and erythema with a diameter of less than 26.5 mm after 10 to 15 minutes, subjects were participated in this study.
- Measurement procedure: A- Ulcer surface area Ulcer surface (UAS) would be calculated by placing a piece of sterilized transparency film over the ulcer and tracing the ulcer perimeter on the film with fine tipped transparency marker. A separate transparency was used for each Ulcer. The tracing is then placed over metric graph paper and the number of 1mm the tracing was counted (only full 1 millimeter squares inside the perimeter is counted and the area was converted to square centimeters). Ulcer area was measured before the beginning of the study and at the end of the first and second months of therapy and this process was repeated a minimum of three times for each measurement with the value obtained two or more times was reported. B-Ulcer volume measurement in cm3 (width x length x depth):
- The patient would be positioned in a relaxed position with the ulcer directed upward.
- The ulcer would be traced on transparent paper and placed over the metric graph paper to have the longest length and width.
- A measuring tape would be directed into the deepest point of the ulcer to record the ulcer depth.
- (width x length x depth)would be calculated to have the volume of the ulcer. B-Ulcer volume measurement in cm3 (width x length x depth):
- The patient would be positioned in a relaxed position with the ulcer directed upward.
- The ulcer would be traced on transparent paper and placed over the metric graph paper to have the longest length and width.
- A measuring tape would be directed into the deepest point of the ulcer to record the ulcer depth.
- (width x length x depth) would be calculated to have the volume of the ulcer
- Treatment procedures:
Participants treated as outpatients, they were given information about the measurement and treatment procedures as well as about the bee venom phonophoresis before the beginning of the treatment, each participant history sheet was taken, they were asked to follow the surgeon and physical therapist instruction and asked to avoid heavy objects lifting as well as smoking.
Steps of the bee venom phonophoresis treatment procedures:
- Position of the participant: Put the participant in the most comfortable and relaxed position which is supine lying position then Remove any clothes above the abdomen to avoid restriction.
- Ultrasound device preparation: the plug of the ultrasound unit was inserted into the main current supply.
- Bee venom gel: the treatment approach (phonophoresis application for bee venom gel) had been prepared. Bee venom gel had been used for the study group and pure ultrasound gel had been used for the control group. Each participant received 0.6 mg up to maximum 1 mg BV gel each session • Phonophoresis application for bee venom gel (study group): A pulsed ultrasound (applicator 1.9 cm 2 ) had been applied around the incision site, the movement was over the incision margins with pulsed duty cycle 40% (4 ms on, 6 ms off), and Power density 0.5 W/cm2 and Time was 5 minutes each session. Treatment sessions were 3 sessions a week, for 3 consecutive weeks .
- Low intensity ultrasound with pure gel (control group): A low intensity pulsed ultrasound (applicator 1.9 cm 2 ) had been applied over the incision margins with pulsed duty cycle 20% (2 ms on, 8 ms off), and Power density 0.8 W/ cm 2 and Time was 5 minutes each session. Treatment sessions were 3 sessions a week, for 3 consecutive weeks 35 and medical treatment.
- Conditions
- Ulcer, Leg
- Being tested
- Bee venom phonophoresis, low intensity ultrasound
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bee venom phonophoresisCombination product
Also called low intensity Ultrasound with bee venom gel
phonophoresis with Bee Venom gel in form of a noncontact low-frequency pulsed ultrasound delivered through Bee Venom gel as a topical treatment at a distance of between 5 and 15 mm from the ulcer wound bed, and time was 10 minutes for each session in addition to conservative treatment of medical ulcer care. The performance of the ultrasound applicator was tested regularly before and after each patient exposure; each test included all relevant acoustic field parameters (pressure amplitude, frequency) and uniformity of the field distribution. This type of test of the acoustic output of the applicators was important to eliminate the possibility of any malfunctioning of the devices.
low intensity ultrasoundDevice
a noncontact low-frequency pulsed ultrasound delivered through plain gel only at a distance of between 5 and 15 mm from the ulcer wound bed, and time was 10 minutes for each session in addition to conservative treatment of medical ulcer care.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | received phonophoresis with Bee Venom gel in form of a noncontact low-frequency pulsed ultrasound delivered through Bee Venom gel as a topical treatment at a distance of between 5 and 15 mm from the ulcer wound bed, and time was 10 minutes for each session in addition to conservative treatment of medical ulcer care. Receives: Combination Product: Bee venom phonophoresis |
| group B | Experimental | received phonophoresis with Bee Venom gel in form of a noncontact low-frequency pulsed ultrasound delivered through Bee Venom gel as a topical treatment at a distance of between 5 and 15 mm from the ulcer wound bed, and time was 10 minutes for each session in addition to conservative treatment of medical ulcer care. Receives: Combination Product: Bee venom phonophoresis |
| group C | Sham comparator | received a noncontact low-frequency pulsed ultrasound delivered through only plain gel without BV gel at a distance of between 5 and 15 mm from the ulcer wound bed, and time was 10 minutes for each session in addition to conservative treatment of medical ulcer care. Receives: Device: low intensity ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ulcer surface area
The ulcer surface area would be estimated by placing a piece of sterilized transparency film over the ulcer and using a fine-tipped transparency marker to trace the ulcer perimeter on the film. Each ulcer was treated with its own transparency. The trace was then placed on metric graph paper, and the count of 1mm squares within the perimeter was counted (only entire 1mm squares were counted, and the area was converted to square centimeters)
Measured: changes from baseline, 6 weeks, 12 weeks of therapy.
ulcer volume measurement
The patient would be in a comfortable position, with the ulcer facing upward. To have the longest length and width, the ulcer would be traced on translucent paper and placed over the metric graph paper. A disposable measuring tape would be directed into the deepest point of the ulcer to record the ulcer depth. The volume of the ulcer would be calculated to have the width x length x depth ratio
Measured: changes from baseline, 6 weeks, 12 weeks of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Aug 2021
- Primary completion20 Jan 2022
- Study completion25 Feb 2022
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 Ulcer, LegStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed othman, Cairo University
- Investigators
- eman othman, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285930
- Sponsor's protocol ID
- 012/003573
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in bee venom or ulcer . we will share the results of this study within 1 year following publication.
Publications
Othman EM, Hamada HA, Mohamed GI, Abdallah GA, Ahmed ZS, Al-Shenqiti AM, Kadry AM. Clinical and histopathological responses to bee venom phonophoresis in treating venous and diabetic ulcers: a single-blind randomized controlled trial. Front Med (Lausanne). 2023 Apr 20;10:1085544. doi: 10.3389/fmed.2023.1085544. eCollection 2023.
PubMed 37153087
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bee Venom Phonophoresis on Healing of Chronic Lower Limb Ulcers
- ClinicalTrials.gov ID
- NCT05285930
- Acronym / sponsor ID
- 012/003573
- Conditions
- Ulcer, Leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 18 Mar 2022 (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.
PURPOSE: to determine the impact of bee venom phonophoresis in accelerating ulcers healing.
BACKGROUND: Bee venom (BV) phonophoresis has been suggested as a noninvasive treatment for a number of inflammatory conditions and in healing of ulcers.
Ulceration due to vascular causes is often multifactorial and can be caused by both arterial and venous disease. Hypertension and atherosclerosis of the peripheral vessels lead to arterial disease associated with ischemic ulcers. Chronic venous insufficiency and the resulting venous hypertension cause venous ulcers.
There are lack in knowledge and information in published studies about the efficacy of bee venom phonophoresis as physical therapy modality in accelerating ulcers healing.
So, this study will be designed to provide a guideline about the efficacy of of bee venom phonophoresis in accelerating ulcers healing.
HYPOTHESES:
It will be hypothesized that:
It was hypothesized that Bee venom phonophoresis has no or limited effect in accelerating ulcers healing.
RESEARCH QUESTION: Does Bee venom phonophoresis an effect in accelerating ulcers healing?
Detailed description
- A verbal explanation about the importance of this research procedure, main aims and conceptual approaches were explained to every participant. • Every participant was given his written informed consent for bee venom phonophoresis treatment • The procedures of this study were divided into two main parts: part one (measurement procedures) and part two (treatment procedures).
Bee venom allergy test: The participants had been tested for BV allergy; diluted BV, 0.05 ml, in normal saline (1 mg/ml) was injected intra-dermally into the forearm. If the tested lesion resulted in a wheal with a diameter of less than 10 mm and erythema with a diameter of less than 26.5 mm after 10 to 15 minutes, subjects were participated in this study.
- Measurement procedure: A- Ulcer surface area Ulcer surface (UAS) would be calculated by placing a piece of sterilized transparency film over the ulcer and tracing the ulcer perimeter on the film with fine tipped transparency marker. A separate transparency was used for each Ulcer. The tracing is then placed over metric graph paper and the number of 1mm the tracing was counted (only full 1 millimeter squares inside the perimeter is counted and the area was converted to square centimeters). Ulcer area was measured before the beginning of the study and at the end of the first and second months of therapy and this process was repeated a minimum of three times for each measurement with the value obtained two or more times was reported. B-Ulcer volume measurement in cm3 (width x length x depth):
- The patient would be positioned in a relaxed position with the ulcer directed upward.
- The ulcer would be traced on transparent paper and placed over the metric graph paper to have the longest length and width.
- A measuring tape would be directed into the deepest point of the ulcer to record the ulcer depth.
- (width x length x depth)would be calculated to have the volume of the ulcer. B-Ulcer volume measurement in cm3 (width x length x depth):
- The patient would be positioned in a relaxed position with the ulcer directed upward.
- The ulcer would be traced on transparent paper and placed over the metric graph paper to have the longest length and width.
- A measuring tape would be directed into the deepest point of the ulcer to record the ulcer depth.
- (width x length x depth) would be calculated to have the volume of the ulcer
- Treatment procedures:
Participants treated as outpatients, they were given information about the measurement and treatment procedures as well as about the bee venom phonophoresis before the beginning of the treatment, each participant history sheet was taken, they were asked to follow the surgeon and physical therapist instruction and asked to avoid heavy objects lifting as well as smoking.
Steps of the bee venom phonophoresis treatment procedures:
- Position of the participant: Put the participant in the most comfortable and relaxed position which is supine lying position then Remove any clothes above the abdomen to avoid restriction.
- Ultrasound device preparation: the plug of the ultrasound unit was inserted into the main current supply.
- Bee venom gel: the treatment approach (phonophoresis application for bee venom gel) had been prepared. Bee venom gel had been used for the study group and pure ultrasound gel had been used for the control group. Each participant received 0.6 mg up to maximum 1 mg BV gel each session • Phonophoresis application for bee venom gel (study group): A pulsed ultrasound (applicator 1.9 cm 2 ) had been applied around the incision site, the movement was over the incision margins with pulsed duty cycle 40% (4 ms on, 6 ms off), and Power density 0.5 W/cm2 and Time was 5 minutes each session. Treatment sessions were 3 sessions a week, for 3 consecutive weeks .
- Low intensity ultrasound with pure gel (control group): A low intensity pulsed ultrasound (applicator 1.9 cm 2 ) had been applied over the incision margins with pulsed duty cycle 20% (2 ms on, 8 ms off), and Power density 0.8 W/ cm 2 and Time was 5 minutes each session. Treatment sessions were 3 sessions a week, for 3 consecutive weeks 35 and medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Combination Product: Bee venom phonophoresisreceived phonophoresis with Bee Venom gel in form of a noncontact low-frequency pulsed ultrasound delivered through Bee Venom gel as a topical treatment at a distance of between 5 and 15 mm from the ulcer wound bed, and time was 10 minutes for each session in addition to conservative treatment of medical ulcer care. |
| group B | Experimental | Combination Product: Bee venom phonophoresisreceived phonophoresis with Bee Venom gel in form of a noncontact low-frequency pulsed ultrasound delivered through Bee Venom gel as a topical treatment at a distance of between 5 and 15 mm from the ulcer wound bed, and time was 10 minutes for each session in addition to conservative treatment of medical ulcer care. |
| group C | Sham comparator | Device: low intensity ultrasoundreceived a noncontact low-frequency pulsed ultrasound delivered through only plain gel without BV gel at a distance of between 5 and 15 mm from the ulcer wound bed, and time was 10 minutes for each session in addition to conservative treatment of medical ulcer care. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Eligible patients ranged in age from 40 to 60 years.
- They had not undertaken another physical therapy modality for ulcer healing
- non-smokers
- under their own prescribed medications, and controlled diet therapy as described by their physicians.
- All patients in the diabetic foot ulcer group (group B) were non-insulin dependent and had controlled blood glucose levels.
Key exclusion criteria (5 listed)
- Patients with life-threatening disorders such as renal failure, myocardial infarction.
- any systemic diseases that may interfere with the study's objectives were excluded.
- patients with skin disease.
- any disease that can lead to ulcer rather than diabetes for the diabetic foot ulcer group only, as varicose veins, trauma, peripheral vascular diseases, and/or active malignancy.
- Ulcer with surface area of less than 2 cm2 or more than 8 cm2 would be excluded from the study.
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 |
|---|---|---|
| Bee venom phonophoresisAlso: low intensity Ultrasound with bee venom gelphonophoresis with Bee Venom gel in form of a noncontact low-frequency pulsed ultrasound delivered through Bee Venom gel as a topical treatment at a distance of between 5 and 15 mm from the ulcer wound bed, and time was 10 minutes for each session in addition to conservative treatment of medical ulcer care. The performance of the ultrasound applicator was tested regularly before and after each patient exposure; each test included all relevant acoustic field parameters (pressure amplitude, frequency) and uniformity of the field distribution. This type of test of the acoustic output of the applicators was important to eliminate the possibility of any malfunctioning of the devices. | Combination product | group A, group B |
| low intensity ultrasounda noncontact low-frequency pulsed ultrasound delivered through plain gel only at a distance of between 5 and 15 mm from the ulcer wound bed, and time was 10 minutes for each session in addition to conservative treatment of medical ulcer care. | Device | group C |
Primary outcome
The ulcer surface area
Time frame: changes from baseline, 6 weeks, 12 weeks of therapy.
The ulcer surface area would be estimated by placing a piece of sterilized transparency film over the ulcer and using a fine-tipped transparency marker to trace the ulcer perimeter on the film. Each ulcer was treated with its own transparency. The trace was then placed on metric graph paper, and the count of 1mm squares within the perimeter was counted (only entire 1mm squares were counted, and the area was converted to square centimeters)
ulcer volume measurement
Time frame: changes from baseline, 6 weeks, 12 weeks of therapy.
The patient would be in a comfortable position, with the ulcer facing upward. To have the longest length and width, the ulcer would be traced on translucent paper and placed over the metric graph paper. A disposable measuring tape would be directed into the deepest point of the ulcer to record the ulcer depth. The volume of the ulcer would be calculated to have the width x length x depth ratio
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 Mar 2022.
- Derived from this study: PubMed 37153087Othman EM, Hamada HA, Mohamed GI, Abdallah GA, Ahmed ZS, Al-Shenqiti AM, Kadry AM. Clinical and histopathological responses to bee venom phonophoresis in treating venous and diabetic ulcers: a single-blind randomized controlled trial. Front Med (Lausanne). 2023 Apr 20;10:1085544. doi: 10.3389/fmed.2023.1085544. eCollection 2023.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in bee venom or ulcer . we will share the results of this study within 1 year following publication.
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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.
eman othman, professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bee venom phonophoresis and low intensity ultrasound in people with Ulcer, Leg, run by Cairo 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 5 inclusion and 5 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 Mar 2022. 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. Some participants in this study may receive a placebo. 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?
The ulcer surface area (time frame: changes from baseline, 6 weeks, 12 weeks of therapy.). 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?
On the ClinicalTrials.gov record for NCT05285930, 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 18 Mar 2022.