Study of the Efficacy of PedyPhar® Ointment on the Diabetic Foot Ulcers (PED111)

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

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 Overview

• Status: Terminated
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Drug: Royal Jelly and Panthenol (PedyPhar® Ointment); Drug: Panthenol Ointment

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria University Hospitals
  • Alexandria, Egypt
    • Cairo University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pedyphar; Ointment	Drug: Royal Jelly and Panthenol (PedyPhar® Ointment); 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 ulcerIrrigation 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 ulcerFix the dressing to the ulcer; Other Names: Pedyphar; Panthenol; Royal Jelly; Ointment; Diabetic Foot Ulcer
Active Comparator: Panthenol; Ointment	Drug: Panthenol Ointment; 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 ulcerIrrigation 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 ulcerFix the dressing to the ulcer; Other Names: Panthenol; Ointment; Diabetic foot Ulcer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: European Egyptian Pharmaceutical Industries
• Investigators: Principal Investigator: Samir H Assaad, PhD, Alexandria University Hospitals; Principal Investigator: Hesham M Abdel Samad, PhD, Cairo University Hospitals

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 6, 2012
• First Submitted That Met QC Criteria: February 10, 2012
• First Posted (Estimate): February 13, 2012

Study Record Updates

• Last Update Posted (Estimate): February 20, 2015
• Last Update Submitted That Met QC Criteria: February 19, 2015
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Diabetic; Healing; Ointment; Foot Ulcer; Pedyphar
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Physiological Effects of Drugs; Anti-Infective Agents; Micronutrients; Vitamins; Vitamin B Complex; Propolis; Pantothenic Acid
• Other Study ID Numbers: Pedyphar2012