NCT06374563

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

April 16, 2024

Last Update Submit

April 16, 2024

Conditions

Bee VenomPressure UlcersPhonophoresis

Keywords

phonophoresisbee venom

Outcome Measures

Primary Outcomes (2)

  • wound surface area wound surface area

    ImageJ Software was used to measure the wound size

    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

    Before starting treatment and after 8 weeks of treatment

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1 received topical application of Bee Venom gel, 3 times per week

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

Other: Group 2: Phonophoresis of Bee Venom gel

Interventions

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 1
Group 2: Phonophoresis of Bee Venom gelOTHER

group 2 received phonophoresis of Bee Venom gel using low frequency ultrasound, 3 times per weeks

group 2

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Patients with stage II and III chronic neuropathic ulcers.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr University in Cairo

Cairo, 11837, Egypt

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ashraf Hassan, professor

    Badr University in Cairo

    STUDY DIRECTOR

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
lecturer of physical therapy

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 18, 2024

Study Start

November 9, 2022

Primary Completion

January 1, 2024

Study Completion

March 1, 2024

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)