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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by European Egyptian Pharmaceutical Industries.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
European Egyptian Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01531517
First received: February 6, 2012
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Diabetic Foot Ulcer
Drug: Royal Jelly and Panthenol (PedyPhar® Ointment)
Drug: Panthenol Ointment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by European Egyptian Pharmaceutical Industries:

Primary Outcome Measures:
  • Healing of the Ulcer [ Time Frame: within 5 months or complete healing whichever comes first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reduction of infection in the ulcer site [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • local reaction that may be due to study drug [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  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
Active Comparator: Panthenol
Ointment
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531517

Contacts
Contact: Alaa Abou-Zeid, PhD +2 02 2690 9510 abouzeida@scidreco.com
Contact: Noha Sami, BSc.Pharm. +2 02 2690 9510 samin@scidreco.com

Locations
Egypt
Alexandria University Hospitals Recruiting
Alexandria, Egypt
Contact: Samir H Assaad, PhD    +2 0122 219 7789    assaadkhalils@gmail.com   
Principal Investigator: Samir H Assaad, PhD         
Cairo University Hospitals Recruiting
Alexandria, Egypt
Contact: Hesham M Abdel-Samad, PhD         
Principal Investigator: Hesham M Abdel-Samad, PhD         
Sponsors and Collaborators
European Egyptian Pharmaceutical Industries
Investigators
Principal Investigator: Samir H Assaad, PhD Alexandria University Hospitals
Principal Investigator: Hesham M Abdel Samad, PhD Cairo University Hospitals
  More Information

No publications provided

Responsible Party: European Egyptian Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01531517     History of Changes
Other Study ID Numbers: Pedyphar2012
Study First Received: February 6, 2012
Last Updated: February 10, 2012
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by European Egyptian Pharmaceutical Industries:
Pedyphar
Ointment
Healing
Diabetic
Foot Ulcer

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Foot Diseases
Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Vascular Diseases
Propolis
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014