Clinical trial NCT01531517: Study of the Efficacy of PedyPhar® Ointment on the Diabetic Foot Ulcers
Official title: Study of the Efficacy of Topical Application of Royal Jelly and Panthenol (PedyPhar® Ointment) on the Diabetic Foot Ulcers, An Open Label, Randomized, Non-placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Foot Ulcer
Keywords: Pedyphar
Ointment
Healing
Diabetic
Foot Ulcer
Lead sponsor: European Egyptian Pharmaceutical Industries
Sponsor class: INDUSTRY
First posted: 2012-02-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical Trial Phase III-b

Study Sponsor:

European Egyptian Pharmaceutical Industries

Sample Size:

120 patients (60 per arm)

Study Population:

Patients with Diabetic foot ulcer of any stage after proper surgical treatment - if needed. Those patients will be recruited from patients attending the Diabetic foot Center at Faculty of Medicine - Alexandria University and the outpatient clinic at Faculty of Medicine, Cairo University.

Recruitment Period: 9 months

Dose application: thick layer of 2-3 mm applied to the dressing then dressing applied to the ulcer.

Endpoints: Complete healing of the ulcer OR 5 months of application of the ointment whichever comes first

Detailed description: Study Design:

This is an open label randomized non-placebo study in which 120 subjects will be randomly allocated to treatment with PedyPhar ointment or Panthenol ointment for their diabetic foot ulcer. Treatment with the ointment will be preceded by appropriate surgical treatment to remove necrotic tissue as indicated by a surgeon for foot ulcer Wagner stages 3-5. Also, diabetic status will be controlled as part of the study. Ointment in either arm will be applied to the ulcer for a maximum of 5 months or till complete healing whichever happens first.

Patients will visit study center every 2 weeks where assessment of the ulcer will be done and patient will be given the ointment for the dressing enough for 2 weeks.

Blood flow in the affected leg will be assessed besides kidney functions complete blood picture besides kidney functions. Diabetic status will be monitored every months and glycosylated hemoglobin will be done every 3 months

Study Duration: 12 months

Study Agent/Intervention Description: PEDYPHAR® is a new patented local ointment composed of natural (Royal Jelly) and (Dexpanthenol) in an innovated, enriched alkaline ointment base.

Dose application: thick layer of 2-3 mm applied to the dressing then dressing applied to the ulcer.

Eligibility criteria: Inclusion Criteria:

* Adult diabetic foot syndrome subjects over 18 years of age of any sex
* All stages of diabetic foot syndrome including Wagner stage 5 - Mid-foot gangrene only after appropriate surgical treatment.
* Patients suffering from type 1 or type 2 diabetes mellitus with diabetic foot syndrome.
* Stable metabolic and pharmacological control at recruitment and during the trial period.
* Adequate perfusion of lower limb as measured by HHD and confirmed by APSV.

Exclusion Criteria:

* Non-diabetic foot ulceration (traumatic, thermal ulceration etc)
* Diabetic foot syndrome graded 5 on Wagner's scale - hind foot gangrene only.
* Any pathological state or disease which can affect the development and outcomes of diabetic foot syndrome such as liver cell failure and renal failure
* Severe limb ischemia (by clinical assessment and HHD) unless re-vascularized.
* Presence of slough or sequestrum unless debrided.
* Hemoglobin less than 8 g/dl unless corrected.
* Those receiving NSAIDs, steroids or anti-mitotic drugs.
* Septicemia patients requiring urgent amputation.

Primary outcomes:
measure: Healing of the Ulcer
timeFrame: within 5 months or complete healing whichever comes first
Secondary outcomes:
measure: reduction of infection in the ulcer site
timeFrame: 5 months
measure: local reaction that may be due to study drug
timeFrame: 5 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Hospitals
city: Alexandria
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Alexandria University Hospitals
name: Samir H Assaad, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University Hospitals
name: Hesham M Abdel Samad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yakoot M, Abdelatif M, Helmy S. Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study. Diabetes Metab Syndr Obes. 2019 Sep 2;12:1659-1665. doi: 10.2147/DMSO.S210680. eCollection 2019.