Effect of Bee Venom Phonophoresis on Healing of Chronic Lower Limb Ulcers
Condition: Ulcer, Leg
MeSH terms: Leg Ulcer; Ulcer
Study type: Interventional

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?
    

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.

        1. 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

        2. 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.
    

Intervention name(s): Bee venom phonophoresis; low intensity ultrasound
Intervention type(s): Combination Product; Device
Intervention description(s): 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.; 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.
Other intervention name(s): low intensity Ultrasound with bee venom gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment