Efficacy & Safety of Pedyphar Ointment in Diabetic Foot Ulcer Treatment

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 pasthistory of Diabetes Mellitus and/or the use of anti-diabetic medications for thetreatment 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 TexasUniversity 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 yearsprior to screening.

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

8. Mild ( Presence of ≥ 2 manifestations of inflammation (purulence, or erythema,pain, tenderness, warmth, or indurations),any cellulitis/erythema extending ≤ 2cm around the ulcer, and infection is limited to the skin or superficialsubcutaneous tissues; no other local complications or systemic illness). Or:

9. Moderate Infection (as above) in a patient who is systemically well andmetabolically stable but which has ≥1 of the following characteristics:cellulitis extending >2 cm, lymphangitic streaking, spread beneath thesuperficial fascia, deep-tissue abscess, gangrene, and involvement of muscle,tendon, joint or bone.

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

11. Be willing and able to participate in the study as an outpatient, make the requiredvisits to the study center during the treatment periods, and comply with studyrequirements.

12. 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, severehyperglycemia, 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 [Hyperpigmentation, Venous dermatitis, Chronic cellulitis, Cutaneous infarction (atrophieblanche), Ulceration]

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

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

14. History of moderate to severe ischemic heart disease or any history of congestiveheart 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 approvetheir participation in the study.

17. Refusal to give informed consent.

18. Pregnant or Breastfeeding subjects.