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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Foot Ulcer | Drug: Royal Jelly and Panthenol (PedyPhar® Ointment) Drug: Panthenol Ointment | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2013 |

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:
Other Names:
|
Active Comparator: Panthenol
Ointment
|
Drug: Panthenol Ointment
the following will be done to each patient depending on the number of the visit:
Other Names:
|
- Healing of the Ulcer [ Time Frame: within 5 months or complete healing whichever comes first ]
- reduction of infection in the ulcer site [ Time Frame: 5 months ]
- local reaction that may be due to study drug [ Time Frame: 5 months ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531517
Egypt | |
Alexandria University Hospitals | |
Alexandria, Egypt | |
Cairo University Hospitals | |
Alexandria, Egypt |
Principal Investigator: | Samir H Assaad, PhD | Alexandria University Hospitals | |
Principal Investigator: | Hesham M Abdel Samad, PhD | Cairo University Hospitals |
Responsible Party: | European Egyptian Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT01531517 |
Other Study ID Numbers: |
Pedyphar2012 |
First Posted: | February 13, 2012 Key Record Dates |
Last Update Posted: | February 20, 2015 |
Last Verified: | February 2012 |
Pedyphar Ointment Healing Diabetic Foot Ulcer |
Diabetic Foot Foot Ulcer Ulcer Pathologic Processes Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases Diabetes Complications Diabetes Mellitus |
Endocrine System Diseases Diabetic Neuropathies Foot Diseases Pantothenic Acid Propolis Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Anti-Infective Agents |