Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01531517
Recruitment Status : Terminated (inability to recruit patients)
First Posted : February 13, 2012
Last Update Posted : February 20, 2015
Sponsor:
Information provided by (Responsible Party):
European Egyptian Pharmaceutical Industries

Tracking Information
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
 (submitted: February 10, 2012)
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
 (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  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

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 19, 2015)
47
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2012)
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:

  • 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  ICMJE
Sexes Eligible for Study: All
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
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP