- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02379468
Efficacy & Safety of Pedyphar Ointment in Diabetic Foot Ulcer Treatment (PEDFUT)
March 4, 2015 updated by: European Egyptian Pharmaceutical Industries
Phase IIIb, A Prospective, Open Label, Randomized, Controlled, Parallel Group, Multicenter Clinical Trial of 3 Months Duration Comparing Topical Application of Royal Jelly and Panthenol (PEDYPHAR® Ointment) to Panthenol Ointment Only for Diabetic Foot Ulcers Treatment.
The purpose of this study is to evaluate the efficacy and safety of Pedyphar® ointment in the healing of foot ulceration in diabetic patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alexandria, Egypt, 21500
- Alexandria University
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Cairo, Egypt
- Ain Shames University
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Suez, Egypt
- Suez Canal University
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Please select
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Tanta, Please select, Egypt
- Tanta University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written informed consent signed and dated by study subject.
- Male or Female patients.
- Age is ≥18 years old and ≤ 70 years old.
- Clinical diagnosis of Diabetes Mellitus Type I or II with diabetic foot ulcer. A past history of Diabetes Mellitus and/or the use of anti-diabetic medications for the treatment of Diabetes Mellitus with diabetic foot ulcer are sufficient.
- Presence of 1 or more DFU, less than 15 cm in its biggest diameter, with a Texas University grade ≤ 2 and ≤ grade 2 according to the Wagner Grading system.
- Diabetic foot ulcer has been present for at least 4 weeks and no more than 2 years prior to screening.
If there is Diabetic Foot Ulcer Infection, It must be:
Mild ( Presence of ≥ 2 manifestations of inflammation (purulence, or erythema, pain, tenderness, warmth, or indurations),any cellulitis/erythema extending ≤ 2 cm around the ulcer, and infection is limited to the skin or superficial subcutaneous tissues; no other local complications or systemic illness).
Or:
- Moderate Infection (as above) in a patient who is systemically well and metabolically stable but which has ≥1 of the following characteristics: cellulitis extending >2 cm, lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, and involvement of muscle, tendon, joint or bone.
- If subject is female and of childbearing potential, she agrees to use a medically acceptable physical barrier method contraceptive during the treatment phase.
- Be willing and able to participate in the study as an outpatient, make the required visits to the study center during the treatment periods, and comply with study requirements.
- Receiving medical care for diabetes.
Exclusion Criteria:
- DFU with a Texas score >2 and > grade 2 according to the Wagner Grading system.
- Severe Infected DFU with clinical or para-clinical findings suggesting osteomyelitis (Infection in a patient with systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, severe hyperglycemia, or azotemia)
- Clinically defined and documented severe arterial disease.
- History of radiation therapy to the ulcer site.
- If the study subject has Foot Ulcer of no diabetic pathophysiology.
- Receiving corticosteroids or immune suppressive agents.
- History of immune-vascular disease.
- Known hypersensitivity to any component of Pedyphar® or Panthenol.
- Patients undergoing hemodialysis.
- Insufficient blood supply to Lower Limb (ankle-brachial index < 0.9).
- Clinical findings suggesting complicated venous insufficiency of LL. Edema [Hyper pigmentation, Venous dermatitis, Chronic cellulitis, Cutaneous infarction (atrophie blanche), Ulceration]
- Received treatment with any other investigational drug or device within the last 30 days
- Unable to comply with the procedures described in the protocol
- History of moderate to severe ischemic heart disease or any history of congestive heart failure, or has had a myocardial infarction within the previous 6 months.
- Patients with a history of major hematological, renal or hepatic abnormalities.
- Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.
- Refusal to give informed consent.
- Pregnant or Breastfeeding subjects.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pedyphar
Ointment
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Active Comparator: Panthenol
Ointment
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Ointment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of diabetic patients with successful healing of foot ulceration in treated with Pedyphar® ointment
Time Frame: 12 weeks
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Efficacy
|
12 weeks
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Time to complete wound healing within 12 weeks before the end of treatment duration.
Time Frame: 12 weeks
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the healing process of Diabetic foot ulcer using Pedyphar® ointment compared with Panthenol ointment regarding changes of foot ulcer dimensions from baseline visit to the end of the study.
Time Frame: 12 weeks
|
12 weeks
|
To identify the reasons of treatment failure and delayed response
Time Frame: 12 weeks
|
12 weeks
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To identify adverse events associated with the application of Pedyphar® ointment.
Time Frame: 12 weeks
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12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Samir H. Asaad, Prof., Alexandria University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
February 19, 2015
First Submitted That Met QC Criteria
March 4, 2015
First Posted (Estimate)
March 5, 2015
Study Record Updates
Last Update Posted (Estimate)
March 5, 2015
Last Update Submitted That Met QC Criteria
March 4, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EEPI_ PED_001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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