A Phase 3 interventional study of Royal Jelly and Panthenol (PedyPhar® Ointment) and Panthenol Ointment in Diabetic Foot Ulcer, sponsored by European Egyptian Pharmaceutical Industries. Terminated at 2 sites in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-02-20.
Sponsored by European Egyptian Pharmaceutical Industries · Phase 3, Interventional, and Treatment
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
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 47 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →European Egyptian Pharmaceutical Industries is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ointment
Drug: Royal Jelly and Panthenol (PedyPhar® Ointment)
Ointment
Drug: Panthenol Ointment
the following will be done to each patient depending on the number of the visit: 1. Assessment of the patient for inclusion/exclusion criteria 2. Informed consent process 3. Medical history of the patient 4. Blood withdrawn for investigation 5. Drainage of the ulcer if there is a collection 6. Revascularization as needed and indicated by APSV done at visit 0. 7. Swab from the ulcer for culture and micro-organism count: on detailed visits only. 8. Debridement as needed. 9. Dressing: * Inspection and assessment of the ulcer * Irrigation using 500 ml of saline or as required. * Drying of the ulcer (leave to dry) * Spread a layer of 3 - 5 mm of PedyPhar on a dressing and then apply the dressing to the ulcer * Fix the dressing to the ulcer
Also known as: Pedyphar, Panthenol, Royal Jelly, Ointment, Diabetic Foot Ulcer
the following will be done to each patient depending on the number of the visit: 1. Assessment of the patient for inclusion/exclusion criteria 2. Informed consent process 3. Medical history of the patient 4. Blood withdrawn for investigation 5. Drainage of the ulcer if there is a collection 6. Revascularization as needed and indicated by APSV done at visit 0. 7. Swab from the ulcer for culture and micro-organism count: on detailed visits only. 8. Debridement as needed. 9. Dressing: * Inspection and assessment of the ulcer * Irrigation using 500 ml of saline or as required. * Drying of the ulcer (leave to dry) * Spread a layer of 3 - 5 mm of Panthenol on a dressing and then apply the dressing to the ulcer * Fix the dressing to the ulcer
Also known as: Panthenol, Ointment, Diabetic foot Ulcer
Healing of the Ulcer
Time frame: within 5 months or complete healing whichever comes first
reduction of infection in the ulcer site
Time frame: 5 months
local reaction that may be due to study drug
Time frame: 5 months
This study is terminated, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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European Egyptian Pharmaceutical Industries