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Effect of a new local ointment for diabetic foot infection

A PILOT STUDY OF SAFETY AND EFFICACY OF A NEW LOCAL OINTMENT “PEDYPHAR” IN THE TREATMENT OF LIMB-THREATENING DIABETIC FOOT INFECTION.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000209493
Enrollment
60
Registered
2007-04-16
Start date
2005-03-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 patie

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.

Sponsors

Dr. Mostafa Yakoot; Dr. Mohamed Etman
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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).

Exclusion criteria

We excluded group (3) with gangrenous lesion (Wagner 4 and 5).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026