Study of the Efficacy of PedyPhar® Ointment on the Diabetic Foot Ulcers
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Drug: Royal Jelly and Panthenol (PedyPhar® Ointment)
- Registration Number
- NCT01531517
- Lead Sponsor
- European Egyptian Pharmaceutical Industries
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 47
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pedyphar Royal Jelly and Panthenol (PedyPhar® Ointment) Ointment Panthenol Panthenol Ointment Ointment
- Primary Outcome Measures
Name Time Method Healing of the Ulcer within 5 months or complete healing whichever comes first
- Secondary Outcome Measures
Name Time Method local reaction that may be due to study drug 5 months reduction of infection in the ulcer site 5 months
Trial Locations
- Locations (2)
Alexandria University Hospitals
🇪🇬Alexandria, Egypt
Cairo University Hospitals
🇪🇬Alexandria, Egypt