Diabetic Foot UlcerPhase 3PED111NCT01531517
Study of the Efficacy of PedyPhar® Ointment on the Diabetic Foot Ulcers
A Phase 3 study testing Royal Jelly and Panthenol (PedyPhar® Ointment) and Panthenol Ointment in people with Diabetic Foot Ulcer, run by European Egyptian Pharmaceutical Industries at 2 sites in Egypt.
Trial 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. 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?
- Royal Jelly and Panthenol (PedyPhar® Ointment) and Panthenol Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesEgypt
- Study dates
- Jul 2011to Jul 2013
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Alexandria University Hospitals
Alexandria
Cairo University Hospitals
Alexandria
About this study
Official title: Study of the Efficacy of Topical Application of Royal Jelly and Panthenol (PedyPhar® Ointment) on the Diabetic Foot Ulcers, An Open Label, Randomized, Non-placebo-controlled Study
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
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Royal Jelly and Panthenol (PedyPhar® Ointment), Panthenol Ointment
- Keywords
- Pedyphar, Ointment, Healing, Diabetic, Foot Ulcer
- Medical subject headings
- Diabetic Foot, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Royal Jelly and Panthenol (PedyPhar® Ointment)Drug
Also called Pedyphar, Panthenol, Royal Jelly, Ointment
the following will be done to each patient depending on the number of the visit:
- Assessment of the patient for inclusion/exclusion criteria
- Informed consent process
- Medical history of the patient
- Blood withdrawn for investigation
- Drainage of the ulcer if there is a collection
- Revascularization as needed and indicated by APSV done at visit 0.
- Swab from the ulcer for culture and micro-organism count: on detailed visits only.
- Debridement as needed.
- 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
Panthenol OintmentDrug
Also called Panthenol, Ointment, Diabetic foot Ulcer
the following will be done to each patient depending on the number of the visit:
- Assessment of the patient for inclusion/exclusion criteria
- Informed consent process
- Medical history of the patient
- Blood withdrawn for investigation
- Drainage of the ulcer if there is a collection
- Revascularization as needed and indicated by APSV done at visit 0.
- Swab from the ulcer for culture and micro-organism count: on detailed visits only.
- Debridement as needed.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Pedyphar | Experimental | Ointment Receives: Drug: Royal Jelly and Panthenol (PedyPhar® Ointment) |
| Panthenol | Active comparator | Ointment Receives: Drug: Panthenol Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of the Ulcer
Measured: within 5 months or complete healing whichever comes first
Secondary outcomes (2)
reduction of infection in the ulcer site
Measured: 5 months
local reaction that may be due to study drug
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionJul 2013
Why it stopped: inability to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Egyptian Pharmaceutical Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samir H Assaad, PhD, Principal investigator, Alexandria University HospitalsHesham M Abdel Samad, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531517
- Sponsor's protocol ID
- Pedyphar2012
- Acronym
- PED111
- Status last verified
- Feb 2012
- First submitted
- 6 Feb 2012
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yakoot M, Abdelatif M, Helmy S. Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study. Diabetes Metab Syndr Obes. 2019 Sep 2;12:1659-1665. doi: 10.2147/DMSO.S210680. eCollection 2019.
PubMed 31564933
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of Topical Application of Royal Jelly and Panthenol (PedyPhar® Ointment) on the Diabetic Foot Ulcers, An Open Label, Randomized, Non-placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01531517
- Acronym / sponsor ID
- PED111 / Pedyphar2012
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Pedyphar, Ointment, Healing, Diabetic, Foot Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inability to recruit patients
- Enrolment
- 47 participants (actual)
- Lead sponsor
- European Egyptian Pharmaceutical IndustriesIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Feb 2012 (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.
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.
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: Royal Jelly and Panthenol (PedyPhar® Ointment)Ointment |
| Panthenol | Active comparator | Drug: Panthenol OintmentOintment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Royal Jelly and Panthenol (PedyPhar® Ointment)Also: Pedyphar, Panthenol, Royal Jelly, Ointmentthe 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 | Pedyphar |
| Panthenol OintmentAlso: Panthenol, Ointment, Diabetic foot Ulcerthe 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 | Drug | Panthenol |
Primary outcome
Healing of the Ulcer
Time frame: within 5 months or complete healing whichever comes first
2 secondary outcomes
reduction of infection in the ulcer site
Time frame: 5 months
local reaction that may be due to study drug
Time frame: 5 months
Results and safety
The study was stopped early (reason given: inability to recruit patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
- Derived from this study: PubMed 31564933Yakoot M, Abdelatif M, Helmy S. Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study. Diabetes Metab Syndr Obes. 2019 Sep 2;12:1659-1665. doi: 10.2147/DMSO.S210680. eCollection 2019.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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 Assaad, PhD principal investigator
Alexandria University Hospitals
Hesham M Abdel Samad, PhD principal investigator
Cairo University
2 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 Royal Jelly and Panthenol (PedyPhar® Ointment) and Panthenol Ointment in people with Diabetic Foot Ulcer, run by European Egyptian Pharmaceutical Industries at 2 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: inability to recruit patients). Results are not available in the source record.
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?
Healing of the Ulcer (time frame: within 5 months or complete healing whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01531517, which also lists 1 linked publication.
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 20 Feb 2015.