Study of the Efficacy of PedyPhar® Ointment on the Diabetic Foot Ulcers

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Egyptian Pharmaceutical Industries
• Treatments: Pantothenic Acid; Propolis

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.