Study of the Efficacy of PedyPhar® Ointment on the Diabetic Foot Ulcers (PED111)
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ClinicalTrials.gov Identifier: NCT01531517 |
Recruitment Status :
Terminated
(inability to recruit patients)
First Posted : February 13, 2012
Last Update Posted : February 20, 2015
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Tracking Information | |||||||
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First Submitted Date ICMJE | February 6, 2012 | ||||||
First Posted Date ICMJE | February 13, 2012 | ||||||
Last Update Posted Date | February 20, 2015 | ||||||
Study Start Date ICMJE | July 2011 | ||||||
Actual Primary Completion Date | July 2012 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Healing of the Ulcer [ Time Frame: within 5 months or complete healing whichever comes first ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study of the Efficacy of PedyPhar® Ointment on the Diabetic Foot Ulcers | ||||||
Official Title ICMJE | 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 | ||||||
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 |
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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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Diabetic Foot Ulcer | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE |
47 | ||||||
Original Estimated Enrollment ICMJE |
120 | ||||||
Actual Study Completion Date ICMJE | July 2013 | ||||||
Actual Primary Completion Date | July 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Egypt | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01531517 | ||||||
Other Study ID Numbers ICMJE | Pedyphar2012 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | European Egyptian Pharmaceutical Industries | ||||||
Study Sponsor ICMJE | European Egyptian Pharmaceutical Industries | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | European Egyptian Pharmaceutical Industries | ||||||
Verification Date | February 2012 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |