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

NCT ID: NCT01531517

Last Updated: 2015-02-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-07-31

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pedyphar

Ointment

Group Type: EXPERIMENTAL

Royal Jelly and Panthenol (PedyPhar® Ointment)

Intervention Type: DRUG

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

Panthenol

Ointment

Group Type: ACTIVE_COMPARATOR

Panthenol Ointment

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Pedyphar; Panthenol; Royal Jelly; Ointment; Diabetic Foot Ulcer; Panthenol; Ointment; Diabetic foot Ulcer

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Egyptian Pharmaceutical Industries

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samir H Assaad, PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University Hospitals

Hesham M Abdel Samad, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Alexandria University Hospitals

Alexandria, , Egypt

Cairo University Hospitals

Alexandria, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 31564933 (View on PubMed)

Other Identifiers

Pedyphar2012

Identifier Type: -

Identifier Source: org_study_id