Efficacy & Safety of Pedyphar Ointment in Diabetic Foot Ulcer Treatment

Diabetic Foot Ulcer Clinical Trial

— PEDFUT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379468
• Other study ID #: EEPI_ PED_001
• Status: Completed
• Phase: Phase 3
• First received: February 19, 2015
• Last updated: March 4, 2015
• Start date: April 2013
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: European Egyptian Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Written informed consent signed and dated by study subject.

2. Male or Female patients.

3. Age is =18 years old and = 70 years old.

4. 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.

5. 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.

6. Diabetic foot ulcer has been present for at least 4 weeks and no more than 2 years prior to screening.

7. If there is Diabetic Foot Ulcer Infection, It must be:

1. 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:

2. 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.

8. If subject is female and of childbearing potential, she agrees to use a medically acceptable physical barrier method contraceptive during the treatment phase.

9. 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.

10. Receiving medical care for diabetes.

Exclusion Criteria:

1. DFU with a Texas score >2 and > grade 2 according to the Wagner Grading system.

2. 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)

3. Clinically defined and documented severe arterial disease.

4. History of radiation therapy to the ulcer site.

5. If the study subject has Foot Ulcer of no diabetic pathophysiology.

6. Receiving corticosteroids or immune suppressive agents.

7. History of immune-vascular disease.

8. Known hypersensitivity to any component of Pedyphar® or Panthenol.

9. Patients undergoing hemodialysis.

10. Insufficient blood supply to Lower Limb (ankle-brachial index < 0.9).

11. Clinical findings suggesting complicated venous insufficiency of LL. Edema [Hyper pigmentation, Venous dermatitis, Chronic cellulitis, Cutaneous infarction (atrophie blanche), Ulceration]

12. Received treatment with any other investigational drug or device within the last 30 days

13. Unable to comply with the procedures described in the protocol

14. 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.

15. Patients with a history of major hematological, renal or hepatic abnormalities.

16. Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.

17. Refusal to give informed consent.

18. Pregnant or Breastfeeding subjects.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Drug:
• Pedyphar Ointment

• Panthenol
Ointment

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria
Egypt	Ain Shames University	Cairo
Egypt	Suez Canal University	Suez
Egypt	Tanta University	Tanta	Please select

Sponsors (1)

Lead Sponsor	Collaborator
European Egyptian Pharmaceutical Industries

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of diabetic patients with successful healing of foot ulceration in treated with Pedyphar® ointment	Efficacy	12 weeks	No
Primary	Time to complete wound healing within 12 weeks before the end of treatment duration.		12 weeks	No
Secondary	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.		12 weeks	No
Secondary	To identify the reasons of treatment failure and delayed response		12 weeks	No
Secondary	To identify adverse events associated with the application of Pedyphar® ointment.		12 weeks	Yes