Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000209493
Ethics application status
Approved
Date submitted
28/03/2007
Date registered
16/04/2007
Date last updated
16/04/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a new local ointment for diabetic foot infection
Scientific title
A PILOT STUDY OF SAFETY AND EFFICACY OF A NEW LOCAL OINTMENT “PEDYPHAR” IN THE TREATMENT OF LIMB-THREATENING DIABETIC FOOT INFECTION.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic foot infection 1736 0
Condition category
Condition code
Metabolic and Endocrine 1827 1827 0 0
Diabetes
Skin 1828 1828 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sixty patients presented with limb threatening diabetic foot infection were treated with a new local treatment (PEDYPHAR) based on natural product of honey bees (Royal Jelly)1% and panthenol 5%, in an adjusted alkaline ointment base, after good irrigation and cleansing with normal saline. The lesions were occluded with dressing.
Application of the ointment and the dressing was changed daily for the first week, then 3 times per week thereafter,
Duration of intervention was 9 weeks, and all patients were followed up for a period of 6 months.
Intervention code [1] 1675 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2559 0
Percent of patients with complete healing, improvement of their lesions or treatment failure.
Timepoint [1] 2559 0
At 3 weeks, 9 and 24 weeks after intervention commencement.
Secondary outcome [1] 4405 0
Percent of patients suffering any adverse effects.
Timepoint [1] 4405 0
At week 1 and 9 after intervention commencement.
Secondary outcome [2] 4406 0
Percent of patients with large or ugly healing scars.
Timepoint [2] 4406 0
At week 9 after intervention commencement.

Eligibility
Key inclusion criteria
Patients presented with limb threatening diabetic foot infection. The lesions were then categorized into 3 main clinical groups we included the group 1 and 2 in analysis (1) skin ulcer (Wagner 1 and 2); (2) deep tissue infection and suspected osteomyelitis (Wagner 3).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We excluded group (3) with gangrenous lesion (Wagner 4 and 5).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 500 0
Egypt
State/province [1] 500 0

Funding & Sponsors
Funding source category [1] 1977 0
Self funded/Unfunded
Name [1] 1977 0
Dr. Mahmoud Abdel-Latif.
Country [1] 1977 0
Primary sponsor type
Individual
Name
Dr. Mostafa Yakoot; Dr. Mohamed Etman
Address
Country
Secondary sponsor category [1] 1790 0
None
Name [1] 1790 0
non
Address [1] 1790 0
Country [1] 1790 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3673 0
Amirya ethics commitee
Ethics committee address [1] 3673 0
Amirya, Alexandria
Ethics committee country [1] 3673 0
Egypt
Date submitted for ethics approval [1] 3673 0
Approval date [1] 3673 0
21/02/2005
Ethics approval number [1] 3673 0

Summary
Brief summary
The primary purpose was to study the efficacy and safety of a new local ointment for the treatment of the severe forms of diabetic foot infection as evidenced by the percentage of patients with healed lesions after 3, 9 and 24 weeks from starting treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27778 0
Address 27778 0
Country 27778 0
Phone 27778 0
Fax 27778 0
Email 27778 0
Contact person for public queries
Name 10864 0
Mostafa Yakoot
Address 10864 0
27 Green Street
Moharrem Bey 21121
Alexandria
Country 10864 0
Egypt
Phone 10864 0
+2033913725
Fax 10864 0
Email 10864 0
[email protected]
Contact person for scientific queries
Name 1792 0
Mostafa Yakoot
Address 1792 0
27 Green Street
Moharrem Bey 21121
Alexandria
Country 1792 0
Egypt
Phone 1792 0
+2033913725
Fax 1792 0
Email 1792 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.