Study of the Efficacy of PedyPhar® Ointment on the Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Drug: Royal Jelly and Panthenol (PedyPhar® Ointment)
* Drug: Panthenol Ointment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pedyphar<br>Ointment | Drug: Royal Jelly and Panthenol (PedyPhar® Ointment)<br>* the following will be done to each patient depending on the number of the visit: Assessment of the patient for inclusion/exclusion criteria Informed consent process Medical history of the patient Blood withdrawn for investigation Drainage of the ulcer if there is a collection Revascularization as needed and indicated by APSV done at visit 0. Swab from the ulcer for culture and micro-organism count: on detailed visits only. Debridement as needed. 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<br>* Other names: Diabetic Foot Ulcer;|
| Active Comparator: Panthenol<br>Ointment | Drug: Panthenol Ointment<br>* the following will be done to each patient depending on the number of the visit: Assessment of the patient for inclusion/exclusion criteria Informed consent process Medical history of the patient Blood withdrawn for investigation Drainage of the ulcer if there is a collection Revascularization as needed and indicated by APSV done at visit 0. Swab from the ulcer for culture and micro-organism count: on detailed visits only. Debridement as needed. 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<br>* Other names: Diabetic foot Ulcer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of the Ulcer |  | within 5 months or complete healing whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of infection in the ulcer site |  | 5 months | 
| local reaction that may be due to study drug |  | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pedyphar, Ointment, Healing, Diabetic, Foot Ulcer