Effect of Bee Venom Phonophoresis on Healing of Chronic Lower Limb Ulcers

NCT05285930 | Completed

• 1 other identifier: 012/003573
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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?

Conditions

Ulcer, Leg

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  changes from baseline, 6 weeks, 12 weeks of therapy.

Study Arms (3)

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.

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.

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.

Device: low intensity ultrasound

Interventions

Bee venom phonophoresis COMBINATION_PRODUCT

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.

Also known as: low intensity Ultrasound with bee venom gel

group A; group B

low intensity ultrasound DEVICE

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.

group C

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, 11432, Egypt

Location

Related Publications (1)

• 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.

  PMID: 37153087 DERIVED

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• eman othman, professor

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 18, 2022
• Study Start: August 1, 2021
• Primary Completion: January 20, 2022
• Study Completion: February 25, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: 1 year after publication
• Access Criteria: the criteria will be assessed by the publication of the trial in an international journals.

Locations

EG (1)