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

NCT01531517 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2015-02-20

No results posted yet for this study

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

Conditions

  • Diabetic Foot Ulcer

Interventions

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 Blood withdrawn for investigation 5.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

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 Blood withdrawn for investigation 5.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

Sponsors & Collaborators

  • European Egyptian Pharmaceutical Industries

    lead INDUSTRY

Principal Investigators

  • Samir H Assaad, PhD · Alexandria University Hospitals

  • Hesham M Abdel Samad, PhD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-07-31
Completion
2013-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01531517 on ClinicalTrials.gov