Diabetic Foot UlcerPhase 3PEDFUTNCT02379468
Efficacy & Safety of Pedyphar Ointment in Diabetic Foot Ulcer Treatment
A Phase 3 study testing Pedyphar Ointment and Panthenol in people with Diabetic Foot Ulcer, run by European Egyptian Pharmaceutical Industries at 4 sites in Egypt.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Pedyphar® ointment in the healing of foot ulceration in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Pedyphar Ointment and Panthenol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesEgypt
- Study dates
- Apr 2013to Oct 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Egypt4 sites
Alexandria University
Alexandria, Alexandria Governorate, 21500
Ain Shames University
Cairo
Suez Canal University
Suez
Tanta University
Tanta, Please Select
About this study
Official title: 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Pedyphar Ointment, Panthenol
- Keywords
- Diabetic, Foot, Ulcer
- Medical subject headings
- Diabetic Foot, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedyphar OintmentDrug
PanthenolDrug
Ointment
| Study group | Role | What they receive |
|---|---|---|
| Pedyphar | Experimental | Ointment Receives: Drug: Pedyphar Ointment |
| Panthenol | Active comparator | Ointment Receives: Drug: Panthenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of diabetic patients with successful healing of foot ulceration in treated with Pedyphar® ointment
Efficacy
Measured: 12 weeks
Time to complete wound healing within 12 weeks before the end of treatment duration.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 12 weeks
To identify the reasons of treatment failure and delayed response
Measured: 12 weeks
To identify adverse events associated with the application of Pedyphar® ointment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startApr 2013
- Primary completionAug 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Egyptian Pharmaceutical Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samir H. Asaad, Prof., Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379468
- Sponsor's protocol ID
- EEPI_ PED_001
- Acronym
- PEDFUT
- Status last verified
- Feb 2015
- First submitted
- 19 Feb 2015
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02379468
- Acronym / sponsor ID
- PEDFUT / EEPI_ PED_001
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic, Foot, Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- European Egyptian Pharmaceutical IndustriesIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pedyphar | Experimental | Drug: Pedyphar OintmentOintment |
| Panthenol | Active comparator | Drug: PanthenolOintment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pedyphar Ointment | Drug | Pedyphar |
| PanthenolOintment | Drug | Panthenol |
Primary outcome
Percentage of diabetic patients with successful healing of foot ulceration in treated with Pedyphar® ointment
Time frame: 12 weeks
Efficacy
Time to complete wound healing within 12 weeks before the end of treatment duration.
Time frame: 12 weeks
3 secondary outcomes
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
To identify the reasons of treatment failure and delayed response
Time frame: 12 weeks
To identify adverse events associated with the application of Pedyphar® ointment.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir H. Asaad, Prof. principal investigator
Alexandria University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pedyphar Ointment and Panthenol in people with Diabetic Foot Ulcer, run by European Egyptian Pharmaceutical Industries at 4 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of diabetic patients with successful healing of foot ulceration in treated with Pedyphar® ointment (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.