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

• ClinicalTrials.gov Identifier: NCT01531517
• Recruitment Status: Terminated
• First Posted: February 13, 2012
• Last Update Posted: February 20, 2015
• Sponsor: European Egyptian Pharmaceutical Industries
• Information provided by (Responsible Party): European Egyptian Pharmaceutical Industries

Tracking Information

• First Submitted Date: February 6, 2012
• First Posted Date: February 13, 2012
• Last Update Posted Date: February 20, 2015
• Study Start Date: July 2011
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 10, 2012): Healing of the Ulcer [ Time Frame: within 5 months or complete healing whichever comes first ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 10, 2012)

• reduction of infection in the ulcer site [ Time Frame: 5 months ]
• local reaction that may be due to study drug [ Time Frame: 5 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diabetic Foot Ulcer

Intervention

• Drug: Royal Jelly and Panthenol (PedyPhar® 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
  Other Names:

  • Pedyphar
  • Panthenol
  • Royal Jelly
  • Ointment
  • Diabetic Foot Ulcer
• 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 Panthenol on a dressing and then apply the dressing to the ulcer
     • Fix the dressing to the ulcer
  Other Names:

  • Panthenol
  • Ointment
  • Diabetic foot Ulcer

Study Arms

• Experimental: Pedyphar
  Ointment
  Intervention: Drug: Royal Jelly and Panthenol (PedyPhar® Ointment)
• Active Comparator: Panthenol
  Ointment
  Intervention: Drug: Panthenol Ointment

• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 19, 2015): 47
• Original Estimated Enrollment (submitted: February 10, 2012): 120
• Actual Study Completion Date: July 2013
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT01531517
• Other Study ID Numbers: Pedyphar2012
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: European Egyptian Pharmaceutical Industries
• Study Sponsor: European Egyptian Pharmaceutical Industries
• Collaborators: Not Provided

Investigators

• Principal Investigator: Samir H Assaad, PhD; Alexandria University Hospitals
• Principal Investigator: Hesham M Abdel Samad, PhD; Cairo University Hospitals

• PRS Account: European Egyptian Pharmaceutical Industries
• Verification Date: February 2012